Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000212853
Ethics application status
Approved
Date submitted
1/12/2020
Date registered
3/03/2021
Date last updated
16/03/2023
Date data sharing statement initially provided
3/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Yeast protein compared to whey protein and a placebo on muscle mass and performance in an Adult Population – A double blind, randomised controlled trial.
Scientific title
Effect of Yeast protein compared to whey protein and a placebo on muscle mass and performance in an Adult Population – A double blind, randomised controlled trial.
Secondary ID [1] 302913 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle mass 319929 0
Muscle performance 319930 0
Condition category
Condition code
Physical Medicine / Rehabilitation 317867 317867 0 0
Other physical medicine / rehabilitation
Musculoskeletal 317868 317868 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a double blind, randomised, clinical study with 3 groups (2 active ingredient groups and 1 inactive placebo group). AnPro ® is a novel brand of yeast protein extracted from the nutritional yeast species Saccharomyces cerevisiae.

Once enrolled in the study, participants will attend the clinic and be randomly allocated to either a placebo group or one of two active intervention groups and undertake baseline testing. Baseline testing will include a full body scan for muscle mass (dual energy x ray absorptiometry – DXA via referral), muscle strength and endurance test, blood test for safety markers, anthropometric measures (waist and hips circumferences, height and weight), a food frequency questionnaire and 24-hr diet recall.
At the completion of baseline testing, trial product will be provided according to participant randomisation and participants will be asked to start consuming the product taken as a total 40mg dosage in powder form to be made into a drink (20mg in the morning and 20mg at lunch) daily for the duration of the study (8 weeks).

The whey protein in powder form to be made into a drink (taken as a total 40mg dosage (20mg in the morning and 20mg at lunch) daily for the duration of the study (8 weeks) using a commercially available whey protein.

Following the start of trial product, participants will be contacted fortnightly (e.g text message and/or email) to confirm they are still enrolled, still taking product as prescribed and if they have experienced any adverse events and/or study specific symptoms. Participants will be asked to undertake an 8-week training program that can be undertaken anywhere using bodyweight for intensity. Each session is administered by an accredited exercise physiologist. The training program will consist of resistance training of major muscle groups both in the upper and lower body and sessions will be approximately 30 minutes long. All exercises within the program are body weight bearing exercises such as push ups, squats, lunges, burpees, sit-ups and dips. Participants will complete 3 training sessions per week during weeks 1-3 and 5-7 and 2 sessions during assessment weeks 4 and 8. The sessions will be emailed out to participants using a pre-recorded instructional video which they need to play on an electronic device (e.g. smartphone or laptop). Compliance to the exercise program will be monitored throughout the study using a phone based exercise app (e.g. Strava or PhysiTrack) to track each session. During week 4, participants will return to the clinic to repeat the strength and endurance testing and anthropometric measures and return at week 8 to repeat all baseline measurements.

Adherence will be monitored by return and logging of any remaining study product at completion of intervention period.
Intervention code [1] 319197 0
Treatment: Other
Comparator / control treatment
The placebo will be dosed in an identical manner to the yeast protein and whey protein in powder form to be made into a drink (taken as a total 40mg dosage (20mg in the morning and 20mg at lunch) daily for the duration of the study (8 weeks) using carbohydrate placebo.
Control group
Placebo

Outcomes
Primary outcome [1] 325886 0
Changes in lean muscle mass as measured by dual energy x-ray absorptiometry
Timepoint [1] 325886 0
Baseline, week 8 post-intervention commencement
Secondary outcome [1] 389426 0
Muscle strength as measured by 1-RM leg press
Timepoint [1] 389426 0
Baseline, week 4 post-intervention commencement & week 8 post-intervention commencement
Secondary outcome [2] 389427 0
Muscle strength as measured by 1-RM Bench press
Timepoint [2] 389427 0
Baseline, week 4 post-intervention commencement & week 8 post-intervention commencement
Secondary outcome [3] 389428 0
Muscular endurance as measured by 80% 1-Rm leg press reps to fatigue
Timepoint [3] 389428 0
Baseline, week 4 post-intervention commencement & week 8 post-intervention commencement
Secondary outcome [4] 389429 0
Muscle endurance as measured by 80% 1-RM bench press reps to fatigue
Timepoint [4] 389429 0
Baseline, week 4 post-intervention commencement & week 8 post-intervention commencement
Secondary outcome [5] 389430 0
Change in additional body composition measurements (fat mass, % body fat as assessed by dual energy x-ray absorptiometry, BMI (mass assessed with digital scale, height assessed with stadiometer), Body weight, waist circumference, hip circumference) as composite outcome
Timepoint [5] 389430 0
Baseline, week 4 post-intervention commencement & week 8 post-intervention commencement
Secondary outcome [6] 391195 0
Changes in dietary intake as measured by food frequency questionnaire and 24-hour recall
Timepoint [6] 391195 0
Baseline and 8 weeks post intervention commencement
Secondary outcome [7] 391213 0
Changes in safety markers (E/LFT) as measured by serum assay
Timepoint [7] 391213 0
Baseline and 8 weeks post intervention commencement

Eligibility
Key inclusion criteria
• Male aged over 40 years old
• BMI 20.0-34.9
• Able to provide informed consent
• Undertaking low impact cardiovascular exercise including but not limited to cycling, swimming and walking not more than 5 x weekly
• Agree not to take other supplements (including protein or testosterone containing supplements) or medications (e.g. steroids) aimed at muscle mass growth for the duration of the trial.
Minimum age
40 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Currently undertaking resistance training exercise more than once a week
• Unstable or serious illness/impairment (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, Malignancy, lung conditions, chronic asthma, cognitive damage, mood disorders or neurological disorders such as MS)*
• Acute sickness experienced in the past 2 months
• Active smokers and/or nicotine or drug abuse
• Chronic alcohol use (>14 alcoholic drinks week)
• Allergic to any of the ingredients in active or placebo formula (e.g. milk, whey or yeast allergy)
• Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
• Participants who have participated in any other exercise based clinical study during the past 3 month
• People who have or have had treatment for cancer, HIV or use of anabolic steroids in the past year.
• History of orthopedic injuries or surgery in the past 6 months

*An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/03/2021
Actual
27/08/2021
Date of last participant enrolment
Anticipated
Actual
18/06/2022
Date of last data collection
Anticipated
Actual
20/08/2022
Sample size
Target
90
Accrual to date
Final
127
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 307333 0
Commercial sector/Industry
Name [1] 307333 0
Angel Yeast Co., Ltd.
Country [1] 307333 0
China
Primary sponsor type
Commercial sector/Industry
Name
RDC Global Pty Ltd.
Address
3B/76 Doggett street, Newstead QLD, 4006
Country
Australia
Secondary sponsor category [1] 307973 0
Commercial sector/Industry
Name [1] 307973 0
Angel Yeast Co., Ltd.
Address [1] 307973 0
168, Chengdong Avenue, Yichang, Hubei, 443003 P.R. China
Country [1] 307973 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307422 0
Bellberry Limited HREC
Ethics committee address [1] 307422 0
Ethics committee country [1] 307422 0
Australia
Date submitted for ethics approval [1] 307422 0
19/10/2020
Approval date [1] 307422 0
03/06/2021
Ethics approval number [1] 307422 0

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

Contacts
Principal investigator
Name 107186 0
Dr David Briskey
Address 107186 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead QLD 4006
Country 107186 0
Australia
Phone 107186 0
+61 421 784 077
Fax 107186 0
Email 107186 0
[email protected]
Contact person for public queries
Name 107187 0
Amanda Rao
Address 107187 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead QLD 4006
Country 107187 0
Australia
Phone 107187 0
+61 414 488 559
Fax 107187 0
Email 107187 0
[email protected]
Contact person for scientific queries
Name 107188 0
Amanda Rao
Address 107188 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead QLD 4006
Country 107188 0
Australia
Phone 107188 0
+61 414 488 559
Fax 107188 0
Email 107188 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.