Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000298516
Ethics application status
Approved
Date submitted
7/02/2024
Date registered
21/03/2024
Date last updated
21/03/2024
Date data sharing statement initially provided
21/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Nutritional and botanical support for fatigue in burnout: A randomised controlled pilot and feasibility study
Scientific title
Nutritional and botanical support for fatigue in adults with burnout: A randomised controlled pilot and feasibility study
Secondary ID [1] 311366 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burnout 332636 0
Condition category
Condition code
Alternative and Complementary Medicine 329340 329340 0 0
Other alternative and complementary medicine
Mental Health 329341 329341 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of one botanical and nutritional preparation (2 capsules AM) and one nutritional supplement (1 scoop powder PM) or their active controls.
Duration 8 weeks.
Give Back Health RejuveGen AUST L 396075. Oral hard capsule (size OOel vegecap) with grey-green powder. Dose is two capsules every morning. Each capsule contains Astragalus membranaceus root 200 mg (Equivalent Astragalus membranaceus (Dry) 2 g); Bacopa monnieri whole plant 200 mg (Equivalent: Bacopa monnieri (Dry) 4 g); nicotinamide riboside chloride 50 mg
(Equivalent: ribose 25.82 mg); Panax ginseng root 100 mg (Equivalent: Panax ginseng (Dry) 400 mg); quercetin dihydrate 125 mg; Scutellaria baicalensis root 100 mg (Equivalent: Scutellaria baicalensis (Dry) 2 g).

Give Back Health MagRelax AUST L 375975. Oral powder (white) where dose is one scoop of a powder (5.3 g) per day which contains 350 mg of magnesium as magnesium citrate plus 3.0 grams L-glycine. Mix one included scoop (5.3 gram) with water and consume immediately. Take 30 mins before bed.

Adherence to the intervention will be monitored by return of all supplement bottles/containers at each clinic visit.
Intervention code [1] 327869 0
Treatment: Drugs
Comparator / control treatment
The comparator consists of one nutritional supplement (2 capsules AM) and one nutritional supplement (1 scoop powder PM).
Duration 8 weeks.
Give Back Health Immunity Plus AUST L 370572. Oral hard capsule (size O vegecap) with white powder. Dose is two capsules every morning. Each capsule contains ascorbic acid 250 mg; colecalciferol .0125 mg; zinc citrate dihydrate 15.58 mg (Equivalent: zinc 5 mg).

Adherence to comparator will be monitored by return of all supplement bottles/containers at each clinic visit.
Control group
Active

Outcomes
Primary outcome [1] 337246 0
Feasibility as a composite of three measures
Timepoint [1] 337246 0
i) Data will be collected and reported on the numbers of applicants through the whole screening, enrolling and consenting processes
ii) Compliance with the protocol will be checked through collecting and counting discarded products after the bottle exchanges at Study Clinic 2 (Week 4) and Study Clinic 3 (Week 8). iii) At the end of the supplementation phase clinic interview in Week 8.
Primary outcome [2] 337247 0
Safety of the interventions as a composite of two measures.
Timepoint [2] 337247 0
i) Blood tests will be taken within 72 hours after Baseline and within 72 hours after completion of supplements in Week 8
ii) Participants will also be encouraged to report any untoward event directly to the Clinical Trial Co-ordinator or the Chief Investigator. All adverse events associated with this study will be recorded and reported in the Client Report Form. During the trial, any adverse event that may have occured will also be recorded at Study Clinic 2 (Week 4), Study Clinic 3 (Week 8) and follow up (Week 10).
Secondary outcome [1] 431194 0
Burnout (composite)
Timepoint [1] 431194 0
Baseline, week 4, week 8 after commencement of the interventions, and follow-up at week 10.
Secondary outcome [2] 431195 0
Mental wellbeing
Timepoint [2] 431195 0
Baseline, week 4, week 8 after commencement of the interventions, and follow-up at week 10.
Secondary outcome [3] 431196 0
Stress
Timepoint [3] 431196 0
Baseline, week 4, week 8 after commencement of the interventions, and follow-up at week 10.
Secondary outcome [4] 431197 0
Fatigue
Timepoint [4] 431197 0
Baseline, week 4, week 8 after commencement of the interventions, and follow-up at week 10.
Secondary outcome [5] 431198 0
Patient reported outcomes
Timepoint [5] 431198 0
Baseline, week 4, week 8 after commencement of the interventions, and follow-up at week 10.

Eligibility
Key inclusion criteria
• Currently experiencing burnout, as indicated by a score of 50 or higher on the Sydney Burnout Measure (SBM)
• Read, speak, and understand the English language
• Have access to the internet on a computer or smartphone
• Otherwise healthy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• People with diagnosed depression, anxiety, schizophrenia, chronic fatigue syndrome, diabetes, heart disease or who have suffered a stroke, or metabolic disorders such as type II diabetes, polycystic ovary syndrome (PCOS), gastrointestinal disease requiring regular use of medications, gallbladder disease, bacterial or viral infections, epilepsy, neurological conditions such as Parkinson’s disease, and progressive diseases such as cancer will not be eligible for the study.
• People taking regular medication including but not limited to anticholinergics, levadopa/carbidopa, anticoagulant medications such as warfarin, antihypertensive medications including calcium channel blockers such as clozapine, other heart medications such as digoxin, antidiabetic medication, anti-inflammatory medications, such as aspirin or non-steroidal anti-inflammatories, or antibiotics or antiviral medications, or being treated for cancer.
• Current or 12-month history of illicit drug abuse, or alcohol problem
• Planned major life changes in the next 3 months (e.g., moving house)
• Participants (male/female) planning to conceiving within the next 3 months or currently pregnant or lactating
• People who have had a change in medication in the last 3 months or expectation to change during the study duration
• People unwilling to cease other nutritional and herbal supplements in the two weeks prior to the study
• People who have had a history of allergy or adverse or undesirable reactions to the intervention ingredients (magnesium, l-glycine, Panax ginseng, Bacopa monnieri, Astragalus membranaceus, Scutellaria baicalensis, Quercetin, Nicotinamide riboside, Zinc, Vitamin C or Vitamin D)
• People who have participated in other clinical trials within 12 weeks before enrolment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes, allocation concealment will involve contacting the holder of the allocation schedule at the central administration site. This individual is not otherwise involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generation random allocation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint/s
Safety
Statistical methods / analysis
As a pilot trial, sample size and statistical power calculations are not required. The study will aim to recruit 30 participants, to randomise to two groups of n = 15. This is consistent with the minimum 12 subjects per group recommended by Julious (2005). https://onlinelibrary.wiley.com/doi/abs/10.1002/pst.185

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/04/2024
Actual
Date of last participant enrolment
Anticipated
1/07/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 315626 0
Charities/Societies/Foundations
Name [1] 315626 0
Australian Traditional Medicine Society
Country [1] 315626 0
Australia
Primary sponsor type
University
Name
Southern Cross Univerisity
Address
Country
Australia
Secondary sponsor category [1] 317722 0
None
Name [1] 317722 0
Address [1] 317722 0
Country [1] 317722 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314509 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 314509 0
Ethics committee country [1] 314509 0
Australia
Date submitted for ethics approval [1] 314509 0
20/11/2023
Approval date [1] 314509 0
08/03/2024
Ethics approval number [1] 314509 0

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

Contacts
Principal investigator
Name 131838 0
Prof Sandra Grace
Address 131838 0
Faculty of Health Southern Cross Univerisity Military Rd Lismore NSW 2480
Country 131838 0
Australia
Phone 131838 0
+61 2 6620 3646
Fax 131838 0
Email 131838 0
[email protected]
Contact person for public queries
Name 131839 0
Sandra Grace
Address 131839 0
Faculty of Health Southern Cross Univerisity Military Rd Lismore NSW 2480
Country 131839 0
Australia
Phone 131839 0
+61 2 6620 3646
Fax 131839 0
Email 131839 0
[email protected]
Contact person for scientific queries
Name 131840 0
Joanne Bradbury
Address 131840 0
Faculty of Health Southern Cross Univerisy Souther Cross Drive Bilinga QLD 4225
Country 131840 0
Australia
Phone 131840 0
+61 7 5589 3244
Fax 131840 0
Email 131840 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


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.