Skeletal Muscle Hypertrophy Clinical Trial
— SRCTOfficial title:
Effects of a Whey Protein-based Multi-ingredient Supplement on Muscle Strength, Hypertrophy, and the Acute Satellite Cell Response, in Men and Women: a Double-blinded Randomized Controlled Trial
Verified date | January 2020 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Resistance exercise training is a known stimulant for muscle protein synthesis (MPS) to occur, however the consumption of protein is also necessary to induce a shift towards a positive net protein balance. Other nutrients have been shown to be useful in the accretion of lean body mass and strength. Whey protein has been shown to improve muscle net protein balance after resistance exercise, more so when in conjunction with creatine. Furthermore, essential amino acids such as Leucine have been found to be important in moderating the shift towards a positive net protein balance, especially post-exercise and in combination with whey protein. Other vitamins and minerals have been shown to aid in permitting muscle protein synthesis rather than stimulating it, but are still necessary for optimal gains in hypertrophy. The effect of a multi-ingredient compound has rarely been investigated, and thus this study aims to combine whey protein, leucine, creatine, calcium citrate and vitamin D and test it in a resistance exercise training program over 12 weeks. Another novel aspect in this study will be testing this supplement against a placebo of equal amounts of protein and amino acids, the placebo will contain collagen protein and the non-essential amino acids alanine and glycine. Finally, this study will recruit both men and women (ages 18-30) to determine possible effects of the supplement on muscle hypertrophy in both sexes. We hypothesize that the synergistic effect of the ingredients in our supplement will induce hypertrophy to a larger degree than resistance exercise training with the placebo, and that these benefits will persist in both male and female participants.
Status | Completed |
Enrollment | 26 |
Est. completion date | July 1, 2019 |
Est. primary completion date | June 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility |
Inclusion Criteria: - Aged 18-30 years old - Healthy based on questionnaire responses (see exclusion criteria) - Recreationally active (exercising ~2x/week) with some resistance training experience (no more than 2 times weekly) allowed Exclusion Criteria: - Any acute or chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, insulin- or non-insulin dependent diabetes or other metabolic disorders-all ascertained through medical history screening questionnaires - Arthritic conditions - Individuals who consume any analgesic or anti-inflammatory drug(s), prescription or non-prescription, chronically will be excluded - A history of neuromuscular complications - Individuals on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications). - Extensive history of resistance training in the year prior to study entry. - Answers 'yes' to any question on the screening questionnaire |
Country | Name | City | State |
---|---|---|---|
Canada | Exercise Metabolism Research Laboratory, McMaster Univeristy | Hamilton | Ontario |
Canada | Ivor Wynne Center | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University |
Canada,
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Hulmi JJ, Lockwood CM, Stout JR. Effect of protein/essential amino acids and resistance training on skeletal muscle hypertrophy: A case for whey protein. Nutr Metab (Lond). 2010 Jun 17;7:51. doi: 10.1186/1743-7075-7-51. — View Citation
Paddon-Jones D, Sheffield-Moore M, Zhang XJ, Volpi E, Wolf SE, Aarsland A, Ferrando AA, Wolfe RR. Amino acid ingestion improves muscle protein synthesis in the young and elderly. Am J Physiol Endocrinol Metab. 2004 Mar;286(3):E321-8. Epub 2003 Oct 28. — View Citation
Rondanelli M, Klersy C, Terracol G, Talluri J, Maugeri R, Guido D, Faliva MA, Solerte BS, Fioravanti M, Lukaski H, Perna S. Whey protein, amino acids, and vitamin D supplementation with physical activity increases fat-free mass and strength, functionality, and quality of life and decreases inflammation in sarcopenic elderly. Am J Clin Nutr. 2016 Mar;103(3):830-40. doi: 10.3945/ajcn.115.113357. Epub 2016 Feb 10. — View Citation
Tang JE, Manolakos JJ, Kujbida GW, Lysecki PJ, Moore DR, Phillips SM. Minimal whey protein with carbohydrate stimulates muscle protein synthesis following resistance exercise in trained young men. Appl Physiol Nutr Metab. 2007 Dec;32(6):1132-8. — View Citation
Tomlinson PB, Joseph C, Angioi M. Effects of vitamin D supplementation on upper and lower body muscle strength levels in healthy individuals. A systematic review with meta-analysis. J Sci Med Sport. 2015 Sep;18(5):575-80. doi: 10.1016/j.jsams.2014.07.022. Epub 2014 Aug 11. Review. — View Citation
Verreijen AM, Verlaan S, Engberink MF, Swinkels S, de Vogel-van den Bosch J, Weijs PJ. A high whey protein-, leucine-, and vitamin D-enriched supplement preserves muscle mass during intentional weight loss in obese older adults: a double-blind randomized controlled trial. Am J Clin Nutr. 2015 Feb;101(2):279-86. doi: 10.3945/ajcn.114.090290. Epub 2014 Nov 26. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Muscle Mass and fiber cross-sectional area | dual energy x-ray absorptiometry (DXA), ultrasound | 10 weeks | |
Secondary | Satellite cell number, density, type I/type II fibre specific satellite cells and myonuclear domain | Histochemical methods will be used to determine how the supplement and training affect muscle growth and regenerative capacity, specifically the behaviour of satellite cells. | 10 weeks | |
Secondary | Strength | 1RM testing pre- and post-training will be compared to determine how the supplement and training affect muscular strength | 10 weeks | |
Secondary | Fiber type distribution | Histochemical methods will be used to determine how the supplement and training affect fiber type distribution (% type I vs. % type II fibers pre- and post-training) | 10 weeks |
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---|---|---|---|
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