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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05348694
Registration number
NCT05348694
Ethics application status
Date submitted
18/04/2022
Date registered
27/04/2022
Titles & IDs
Public title
OsteoPreP: Food Supplements for Postmenopausal Bone Health
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Scientific title
OsteoPreP: The Effect of Probiotic Supplementation on Bone, Muscle, and Glucose Metabolism in Postmenopausal Women: A Randomised Placebo-controlled Trial
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Secondary ID [1]
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2021-122HC
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Universal Trial Number (UTN)
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Trial acronym
OsteoPreP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Postmenopausal Osteopenia
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Bone Loss, Age Related
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Age-Related Sarcopenia
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Glucose Metabolism Disorders
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Age-related Cognitive Decline
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Condition category
Condition code
Musculoskeletal
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Osteoporosis
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Musculoskeletal
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Other muscular and skeletal disorders
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Metabolic and Endocrine
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0
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Metabolic disorders
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Metabolic and Endocrine
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Other metabolic disorders
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Mental Health
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Pendulum WBF-038
Treatment: Other - Pendulum Placebo
Active comparator: Pendulum WBF-038 - Pendulum WBF-038, a proprietary formulation of the following strains: Akkermansia muciniphila, Clostridium butyricum, Clostridium beijerinckii, Anaerobutyricum hallii, Bifidobacterium infantis, plus chicory inulin and magnesium stearate - 1 capsule with the morning meal and 1 capsule with the evening meal for 12 months.
Placebo comparator: Pendulum Placebo - Pendulum Placebo containing Magnesium stearate - 1 capsule with the morning meal and 1 capsule with the evening meal for 12 months.
Treatment: Other: Pendulum WBF-038
All bacteria contained in Pendulum WBF-038 are commensal organisms that have been repeatedly documented to inhabit the human gastrointestinal tract under normal circumstances. Pendulum's WBF-038 is a proprietary formulation of the following strains: Akkermansia muciniphila, Clostridium butyricum, Clostridium beijerinckii, Anaerobutyricum hallii, Bifidobacterium infantis, plus chicory inulin and magnesium stearate. The organisms were grown under controlled conditions consistent with Good Manufacturing Practices (GMP) and employ no animal-derived products. All ingredients utilized during manufacturing were food grade and qualified as generally recognized as safe (GRAS).
The product is provided as acid-resistant capsules in bottles that are to be stored refrigerated at 4?.
Treatment: Other: Pendulum Placebo
Pendulum placebo capsules containing magnesium stearate
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Total volumetric bone mineral density of the distal tibia
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Assessment method [1]
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Percentage change in total volumetric bone density measured using high resolution peripheral quantitative computed tomography (HR-pQCT) of the distal tibia.
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Timepoint [1]
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12 months
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Secondary outcome [1]
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Bone mineral density of the lumbar spine
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Assessment method [1]
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Relative change in lumbar spine (L1-L4) bone mineral density (BMD) measured using dual energy X-ray absorptiometry (DXA)
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Timepoint [1]
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12 months
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Secondary outcome [2]
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Bone mineral density of the hip
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Assessment method [2]
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Relative change in total hip BMD measured using DXA
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Timepoint [2]
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12 months
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Secondary outcome [3]
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Tibia and radius trabecular bone volume
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Assessment method [3]
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Relative change in tibia and radius trabecular bone volume fraction measured using HR-pQCT
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Timepoint [3]
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12 months
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Secondary outcome [4]
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Tibia and radius cortical area
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Assessment method [4]
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Relative change in tibia and radius cortical area measured using HR-pQCT
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Timepoint [4]
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12 months
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Secondary outcome [5]
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Tibia and radius cortical volumetric bone mineral density
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Assessment method [5]
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Relative change in tibia and radius cortical volumetric BMD measured using HR-pQCT
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Timepoint [5]
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12 months
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Secondary outcome [6]
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Total volumetric bone mineral density of the distal radius
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Assessment method [6]
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Relative change in total volumetric BMD of the distal radius measured using HRpQCT
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Timepoint [6]
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12 months
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Secondary outcome [7]
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Serum C-terminal cross-linking telopeptide of type I collagen (ßCTX-I) - bone turnover marker
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Assessment method [7]
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Relative change in ßCTX-I in serum
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Timepoint [7]
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6 months and 12 months
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Secondary outcome [8]
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Serum procollagen type 1 N-terminal propeptide (P1NP) - bone turnover marker
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Assessment method [8]
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Relative change in P1NP levels in serum
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Timepoint [8]
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6 months and 12 months
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Secondary outcome [9]
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Serum osteocalcin (OC) - bone turnover marker
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Assessment method [9]
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Relative change in OC in serum
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Timepoint [9]
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6 months and 12 months
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Secondary outcome [10]
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Short-chain fatty acids (SCFAs)
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Assessment method [10]
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Relative change in SCFA levels (including butyrate) in stool
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Timepoint [10]
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6 months, 12 months, and 2 weeks post intervention
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Secondary outcome [11]
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16s rRNA genetic sequencing of the gut microbiota
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Assessment method [11]
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Relative change in species-level gut microbiota composition in stool using 16s rRNA sequencing
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Timepoint [11]
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6 months, 12 months, and 2 weeks post intervention
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Secondary outcome [12]
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Fasting blood glucose
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Assessment method [12]
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Relative change in fasted blood glucose levels in circulating blood
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Timepoint [12]
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6 months and 12 months
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Secondary outcome [13]
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Glycated haemoglobin (HbA1c)
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Assessment method [13]
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Relative change in HbA1c levels in circulating blood
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Timepoint [13]
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6 months and 12 months
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Secondary outcome [14]
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Lower leg muscle area
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Assessment method [14]
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Relative change in lower leg muscle area measured using HR-pQCT
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Timepoint [14]
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12 months
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Secondary outcome [15]
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Lean body mass
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Assessment method [15]
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Relative change in appendicular lean body mass measured using DXA
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Timepoint [15]
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12 months
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Secondary outcome [16]
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Grip strength
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Assessment method [16]
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Relative change in left and right hand grip strength measured using a hand dynamometer
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Timepoint [16]
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6 months and 12 months
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Secondary outcome [17]
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High-sensitivity C-reactive protein (hs-CRP)
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Assessment method [17]
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Relative change in hs-CRP levels in serum
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Timepoint [17]
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6 months and 12 months
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Secondary outcome [18]
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Regulatory T lymphocytes (Tregs)
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Assessment method [18]
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Relative change in circulating number of Tregs in blood
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Timepoint [18]
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12 months
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Secondary outcome [19]
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Oral glucose tolerance test (OGTT)
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Assessment method [19]
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Relative change in oral glucose tolerance in circulating blood
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Timepoint [19]
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6 months and 12 months
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Secondary outcome [20]
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Muscle tissue glycogen content
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Assessment method [20]
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Relative change in muscle tissue glycogen content obtained from a muscle biopsy
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Timepoint [20]
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6 months and 12 months
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Secondary outcome [21]
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Muscle tissue triglyceride content
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Assessment method [21]
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Relative change in muscle tissue triglyceride content obtained from a muscle biopsy
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Timepoint [21]
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6 months and 12 months
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Secondary outcome [22]
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Muscle tissue type 1 fibre composition
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Assessment method [22]
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Relative change in muscle tissue type 1 fibre proportion obtained from a muscle biopsy
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Timepoint [22]
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6 months and 12 months
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Secondary outcome [23]
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Lipocalin2
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Assessment method [23]
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Relative change in Lipocalin2 (intestinal inflammation) in stool
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Timepoint [23]
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6 months, 12 months, and 2 weeks post intervention
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Secondary outcome [24]
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Cogstate One back Test Cognitive performance test
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Assessment method [24]
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Relative change in speed of performance and number of errors in the One Back Test using the Cogstate cognitive assessment tool. Lower score = better performance
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Timepoint [24]
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6 months and 12 months
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Secondary outcome [25]
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Cogstate Groton Maze Learning Test Cognitive performance test
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Assessment method [25]
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Relative change in number of errors in the Groton Maze Learning Test using the Cogstate cognitive assessment tool. Lower score = better performance
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Timepoint [25]
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6 months and 12 months
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Secondary outcome [26]
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Cogstate Continuous Paired Associate Learning Test Cognitive performance test
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Assessment method [26]
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Relative change in accuracy of performance and number of errors in the Continuous Paired Associate Learning Test using the Cogstate cognitive assessment tool. Lower score = better performance
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Timepoint [26]
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6 months and 12 months
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Secondary outcome [27]
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Cogstate Social Emotional Cognition Test Cognitive performance test
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Assessment method [27]
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Relative change in accuracy of performance in the Social Emotional Cognition Test using the Cogstate cognitive assessment tool. Higher score = better performance
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Timepoint [27]
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6 months and 12 months
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Secondary outcome [28]
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Depression, Anxiety and Stress Scale 21
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Assessment method [28]
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Relative change in depression, anxiety and stress measured using the Depression Anxiety and Stress Scale 21 (DASS-21) questionnaire. The DASS-21 has a minimum score of 0 and a maximum score of 63 with higher scores indicating a worse outcome.
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Timepoint [28]
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6 months and 12 months
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Secondary outcome [29]
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Gastrointestinal Symptom Rating Scale
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Assessment method [29]
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Relative change in gastrointestinal symptoms measured using the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire. The GSRS has a minimum score of 5 and a maximum score of 45 with higher scores indicating a worse outcome.
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Timepoint [29]
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6 months and 12 months
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Secondary outcome [30]
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Plasma glucagon-like peptide 1
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Assessment method [30]
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Relative change in gut hormone glucagon-like peptide 1 \[GLP-1\] in plasma
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Timepoint [30]
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6 months and 12 months
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Secondary outcome [31]
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Plasma peptide tyrosine-tyrosine
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Assessment method [31]
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Relative change in gut hormone peptide tyrosine-tyrosine \[PYY\] in plasma
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Timepoint [31]
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6 months and 12 months
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Secondary outcome [32]
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Plasma adiponectin
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Assessment method [32]
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Relative change adiponectin in plasma
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Timepoint [32]
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6 months and 12 months
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Secondary outcome [33]
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EuroQol Five Dimensions Quality of life Medical Outcome Survey
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Assessment method [33]
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Relative change in quality of life measured using the EuroQol Five Dimensions (EQ-5D) questionnaire. The EQ-5D has a minimum score of Level 1 and a maximum score of Level 5 with higher levels indicating a worse outcome
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Timepoint [33]
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6 months and 12 months
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Secondary outcome [34]
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Social Interaction Anxiety Scale
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Assessment method [34]
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Relative change in social anxiety measured using the Social Interaction Anxiety Scale (SIAS) questionnaire. The SIAS has a minimum score of 0 and a maximum score of 80 with higher scores indicating a worse outcome.
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Timepoint [34]
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6 months and 12 months
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Secondary outcome [35]
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The Warwick-Edinburgh Mental Wellbeing Scale
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Assessment method [35]
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Relative change in mental wellbeing measured using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) questionnaire. The WEMWBS has a minimum score of 14 and a maximum score of 70 with higher scores indicating a better outcome.
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Timepoint [35]
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6 months and 12 months
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Secondary outcome [36]
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Continuous blood glucose level monitoring for 10 days
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Assessment method [36]
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Relative change in blood glucose (area under the curve) over 10 days measured using a continuous glucose monitoring device
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Timepoint [36]
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6 months and 12 months
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Secondary outcome [37]
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Fasting blood insulin
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Assessment method [37]
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Relative change in fasted blood insulin levels in circulating blood
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Timepoint [37]
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6 months and 12 months
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Secondary outcome [38]
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Fat mass
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Assessment method [38]
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Relative change in total body fat mass measured using DXA
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Timepoint [38]
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12 months
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Secondary outcome [39]
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Blood metabolomics
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Assessment method [39]
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Relative change in blood metabolites using liquid chromatography-mass spectrometry
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Timepoint [39]
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12 months
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Secondary outcome [40]
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Office blood pressure
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Assessment method [40]
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Relative change in Systolic and Diastolic blood pressure measured using a sphygmomanometer
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Timepoint [40]
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6 months and 12 months
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Secondary outcome [41]
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The Visual Analogue Scale Pain Intensity
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Assessment method [41]
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Relative change in current pain intensity measured using a visual analogue scale (VAS) pain intensity scale. The VAS has a minimum score of 0 and a maximum score of 10 with higher scores indicating a worse outcome.
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Timepoint [41]
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6 months and 12 months
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Secondary outcome [42]
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Calprotectin
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Assessment method [42]
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Relative change in calprotectin (intestinal inflammation) in stool
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Timepoint [42]
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6 months, 12 months, and 2 weeks post intervention
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Secondary outcome [43]
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Muscle mass
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Assessment method [43]
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Relative change in total body muscle mass measured using DXA
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Timepoint [43]
0
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12 months
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Eligibility
Key inclusion criteria
* Postmenopausal women, 40-65 years old
* Caucasian (due to significant differences in BMD and bone remodelling between ethnicities)
* At least one year since final menses
* Signed informed consent
* Up to date Covid 19 vaccination status
* Able to walk without the use of an aid
* Stated availability throughout the entire study period
* Mental capacity to understand and willingness to fulfil all the details of the protocol
* Residing in Melbourne, Victoria, Australia
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Minimum age
40
Years
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Maximum age
65
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Diagnosis of osteoporosis
* T-score of -2.5 or less at the femoral neck or lumbar spine (L1-L4) on the DXA scan at screening visit
* HbA1c =6.5% at screening visit
* Blood pressure at screening visit of systolic >180 mmHg and/or diastolic >120 mmHg
* Untreated hyperthyroidism
* Rheumatoid arthritis
* Diagnosed with a disease-causing secondary osteoporosis or malabsorption: chronic obstructive pulmonary disease, inflammatory bowel disease, celiac disease, type 1/type 2 diabetes, or chronic liver disease
* Bariatric surgery
* Recently diagnosed malignancy (within the last 5 years)
* Current or recent oral corticosteroid use (any dose within the last 3 months, or 5mg of Prednisolone (or equivalent) or a higher daily dose for 14 days or more 3-12 months prior to screening)
* Use of antiresorptive therapy, including systemic hormone replacement therapy, bisphosphonates, strontium ranelate (current or during the last 3 years)
* Use of teriparatide (current or during the last 3 years)
* Participation in other clinical intervention trials
* Antibiotics treatment 2 months prior to inclusion
* Unwilling to cease taking other probiotic or prebiotic supplements (current use)
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2025
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Actual
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Sample size
Target
160
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Australian Catholic University - Melbourne
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Australian Catholic University
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
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0
Pendulum Therapeutics
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Address [1]
0
0
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Country [1]
0
0
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Other collaborator category [2]
0
0
Other
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Name [2]
0
0
Curtin University
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Address [2]
0
0
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Country [2]
0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
To evaluate the effect of 12 months of supplementation with a probiotic (probiotic plus prebiotic; 2 capsules per day) on relative change (%) in total volumetric bone density (measured using high resolution peripheral quantitative computed tomography \[HR-pQCT\]) of the distal tibia.
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Trial website
https://clinicaltrials.gov/study/NCT05348694
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
John Hawley, PhD
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Address
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Australian Catholic University
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Country
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0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
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0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05348694