None listed
Conditions
Brief summary
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. The aim of this study is to assess the effectiveness of yeast protein for increasing muscle mass and strength compared to whey protein and a placebo in otherwise healthy adults aged over 40 years old. Yeast protein supplementation is hypothesised to result in equivalent muscle gains when compared to whey protein and superior gains when compared to a placebo.
Interventions
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.
Sponsors
Study design
Eligibility
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.
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.