Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000779774p
Ethics application status
Not yet submitted
Date submitted
26/05/2022
Date registered
31/05/2022
Date last updated
31/05/2022
Date data sharing statement initially provided
31/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of collagen and milk protein on joint comfort and skin appearance in postmenopausal women.
Scientific title
Effects of bovine collagen hydrolysate and hydrolysed milk protein on joint pain, osteoarthritis symptoms, biomarkers of collagen synthesis/degradation and inflammation and skin elasticity and hydration in postmenopausal women with knee pain related to osteoarthritis. A double-blind randomised placebo-controlled parallel study.
Secondary ID [1] 307194 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Joint health 326420 0
Osteoarthritis 326421 0
Inflammation 326422 0
Condition category
Condition code
Musculoskeletal 323703 323703 0 0
Osteoarthritis
Metabolic and Endocrine 323704 323704 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will consume 15g of collagen hydrolysate or hydrolysed milk protein or placebo per day for a total of 16 weeks. The supplements will be provided as powder in plain vacuum-sealed sachets; the powder will be added to drinks or cereal (normal components of the participant's daily diet). Once enrolled in the trial, participants will be randomly allocated to either one of the two active intervention groups or to the placebo comparator group.
All participants will also be provided with a low-dose multivitamin preparation (daily tablet to be taken concurrently with the supplement) to ensure micronutrients essential for collagen synthesis are not rate-limiting. The multivitamin will contain 100mg ascorbic acid, 5mg iron, 10mg zinc, 2mg manganese and 600[micro]g copper and will be supplied from Blackmores Ltd, Australia.
Participants will be monitored for compliance with the protocol by telephone and email communication and a compliance diary (to assess study compliance, nutrient intake and medication use; they will return unused sachets of supplement at the end of the trial.
Intervention code [1] 323643 0
Treatment: Other
Comparator / control treatment
The placebo will be 15g maltodextrin powder in identical sachets
Control group
Placebo

Outcomes
Primary outcome [1] 331452 0
Osteoarthritis symptoms (composite of knee pain and function) as measured by Knee injury and Osteoarthritis Outcome Score (KOOS)
Timepoint [1] 331452 0
Baseline (week 0) and 4, 8, 12 and 16 weeks after starting to take supplement.
Primary outcome [2] 331453 0
Visual analogue scale (VAS) pain score to assess current intensity of knee pain.
Timepoint [2] 331453 0
Baseline (week 0) and 4, 8, 12 and 16 weeks after starting to take supplement.
Primary outcome [3] 331454 0
Biomarker of collagen synthesis: N-terminal type I collagen pro-peptide (PRO-C1) as measured by blood test
Timepoint [3] 331454 0
Baseline (week 0) and 16 weeks after starting to take supplement.
Secondary outcome [1] 409942 0
Primary Outcome. Biomarkers of collagen degradation (C-terminal telopeptide of type II collagen (CTX-II) and cartilage oligomeric matrix protein precursor (COMP) as measured by blood (CTX-II and COMP) and urine tests (CTX-II).
Timepoint [1] 409942 0
Baseline (week 0) and 16 weeks after starting to take supplement.
Secondary outcome [2] 409943 0
Primary Outcome. Skin changes; viscoelasticity, hydration, transdermal water loss, dermal thicknesss as assessed by DermaLab Combo.
Timepoint [2] 409943 0
Baseline (week 0) and 16 weeks after starting to take supplement.
Secondary outcome [3] 409944 0
Quality of Life Bodily Pain Score as measured by 36-Item Short Form questionnaire (SF-36)
Timepoint [3] 409944 0
Baseline (week 0) and 4, 8, 12 and 16 weeks after starting to take supplement.
Secondary outcome [4] 409945 0
Isometric grip force (hand grip strength) assessed by a hand dynamometer..
Timepoint [4] 409945 0
Baseline (week 0) and 16 weeks after starting to take supplement.
Secondary outcome [5] 409946 0
Change in pain medication use as measured by diary
Timepoint [5] 409946 0
Baseline (week 0) and 4, 8, 12 and 16 weeks after starting to take supplement.
Secondary outcome [6] 409947 0
Inflammatory markers (cytokines IL-6, IL-1[beta], TNF[alpha]; high-sensitivity C-reactive protein; erythrocyte sedimentation rate) as measured by blood test
Timepoint [6] 409947 0
Baseline (week 0) and 16 weeks after starting to take supplement.
Secondary outcome [7] 409948 0
Composite outcome of: Body composition (lean:fat ratio) as assessed by whole-body Dual-energy X-ray absorptiometry (DXA) scan, air displacement plethysomography (BodPod) and bioelectrical impedance analysis (BIA); body mass index (BMI; height assessed by stadiometer, weight assessed by digital scales); waist:hip ratio (assessed by tape measure).
Timepoint [7] 409948 0
Baseline (week 0) and 16 weeks after starting to take supplement.
Secondary outcome [8] 409950 0
Lipid profile (serum total, high-density lipoprotein and low-density lipoprotein cholesterol; triglycerides) as measured by blood test
Timepoint [8] 409950 0
Baseline (week 0) and 16 weeks after starting to take supplement.
Secondary outcome [9] 409951 0
Fasting blood glucose as measured by blood test
Timepoint [9] 409951 0
Baseline (week 0) and 16 weeks after starting to take supplement.
Secondary outcome [10] 409952 0
Change in resting blood pressure as measured by Omron automatic blood pressure monitor.
Timepoint [10] 409952 0
Baseline (week 0) and 16 weeks after starting to take supplement.
Secondary outcome [11] 410150 0
Knee function and mobility as measured by Timed Up and Go (TUG) test.
Timepoint [11] 410150 0
Baseline (week 0) and 16 weeks after starting to take supplement.
Secondary outcome [12] 410151 0
Knee function and mobility as measured by 6-minute walk test.
Timepoint [12] 410151 0
Baseline (week 0) and 16 weeks after starting to take supplement.
Secondary outcome [13] 410152 0
Tensile strength of hair as measured by maximum stress (strain rate sensitivity i.e. force per unit cross-sectional area) that a hair can withstand when being pulled or stretched before it breaks.
Timepoint [13] 410152 0
Baseline (week 0) and 16 weeks after starting to take supplement.
Secondary outcome [14] 410153 0
Composite assessment: tensile strength of fingernail clippings assessed by force required to deform and cut nail; nail thickness measured by a handheld electronic micrometer.
Timepoint [14] 410153 0
Baseline (week 0) and 16 weeks after starting to take supplement.

Eligibility
Key inclusion criteria
Healthy post-menopausal (self-reported last menstrual period at least 5 years ago) women.
BMI 20-40
Presence of self-reported knee pain ("Yes" response to "During the past 6 months, have you had any knee pain for more than half the days in the month?") and KOOS pain score indicating mild osteoarthritis.
Willing to stop taking dietary supplements from 4 weeks before and during trial.
Minimum age
50 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Vegetarian
Taking medication (other than over the counter pain relief for osteoarthritis)
Known heart/renal/hepatic disease, rheumatoid arthritis or other autoimmune inflammatory disorders
History of trauma (or surgery) affecting knees
Heavy smoker
Heavy alcohol consumer (more than 2 units of alcohol per day)
High weekly intake of meat

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The supplements will be presented in sealed, coded, plain packaged sachets.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be stratified by age and BMI and assigned to the study groups with a 1:1:1 allocation by an independent researcher using a computer-generated blocked randomisation schedule.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was calculated using G*Power software version 3.0.10 and determined that 27 participants will be required for each group at a 90% power and an alpha level of 5%. To allow for attrition over the 120-day intervention period, the group size is increased to 33.
If necessary, data will be log transformed to achieve normal distributions and homogeneity of variance. SAS Version 9.1 will be used for statistical analysis. Mixed models approach to repeated measures ANOVA will be used and the reported P-values for the effects of treatment group, time, and their interaction will be based on a suitable covariance pattern model (e.g. compound symmetry or first-order autoregression). The baseline results will be included in the model as a covariate and the repeated measures analysis will be based on the results from the intervention period. ANOVA will be followed by post-hoc comparisons of treatment means using the Tukey-Kramer test. Differences between measurements will be considered to be meaningful if p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/07/2022
Actual
Date of last participant enrolment
Anticipated
28/02/2023
Actual
Date of last data collection
Anticipated
31/07/2023
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 24787 0
New Zealand
State/province [1] 24787 0
Manawatu
Country [2] 24788 0
New Zealand
State/province [2] 24788 0
Horowhenua

Funding & Sponsors
Funding source category [1] 311499 0
Government body
Name [1] 311499 0
National Science Challenge High Value Nutrition
Country [1] 311499 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Private Bag 11-222
Tennant Drive
Palmerston North 4444
Country
New Zealand
Secondary sponsor category [1] 312899 0
Commercial sector/Industry
Name [1] 312899 0
Southern Pastures Investments
Address [1] 312899 0
Baker Tilly Staples Rodway Waikato LP
Level 4, BNZ Building
354 Victoria Street
Hamilton
3204
Country [1] 312899 0
New Zealand
Secondary sponsor category [2] 312907 0
Commercial sector/Industry
Name [2] 312907 0
Ovation Ltd
Address [2] 312907 0
PO Box 2646
1st Floor, 210 Maraekakaho
Hastings
4154
Country [2] 312907 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 310959 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 310959 0
Ethics committee country [1] 310959 0
New Zealand
Date submitted for ethics approval [1] 310959 0
07/06/2022
Approval date [1] 310959 0
Ethics approval number [1] 310959 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119502 0
Prof Jane Coad
Address 119502 0
School of Food & Advanced Technology
Massey University
Palmerston North
4444
Country 119502 0
New Zealand
Phone 119502 0
+64 6 951 6321
Fax 119502 0
Email 119502 0
[email protected]
Contact person for public queries
Name 119503 0
Jane Coad
Address 119503 0
School of Food & Advanced Technology
Massey University
Palmerston North
4444
Country 119503 0
New Zealand
Phone 119503 0
+64 6 951 6321
Fax 119503 0
Email 119503 0
[email protected]
Contact person for scientific queries
Name 119504 0
Jane Coad
Address 119504 0
School of Food & Advanced Technology
Massey University
Palmerston North
4444
Country 119504 0
New Zealand
Phone 119504 0
+64 6 951 6321
Fax 119504 0
Email 119504 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
For ethical reasons no individual data will be reported. Data will be presented as group means and standard deviations.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.