NCT03525197: SRCT

Effects of a Multi-ingredient Supplement Study: a Randomized Controlled Trial in Men and Women

Completed NA Last updated 7 January 2020

What this trial tests

NA trial testing Whey protein-based supplement in Skeletal Muscle Hypertrophy in 26 participants. Completed in 1 July 2019.

Timeline

1 September 2018

Primary endpoint
1 June 2019

1 July 2019

Quick facts

Lead sponsor	McMaster University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	26
Start date	1 September 2018
Primary completion	1 June 2019
Estimated completion	1 July 2019
Sites	2 locations across Canada

Drugs / interventions tested

• Whey protein-based supplement
• Collagen protein-based supplement

Conditions studied

• Skeletal Muscle Hypertrophy — all drugs for Skeletal Muscle Hypertrophy →

Sponsor

McMaster University

Who can join

Adults 18 to 30, any sex, with Skeletal Muscle Hypertrophy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Sex-Based Differences in the Myogenic Response and Inflammatory Gene Expression Following Eccentric Contractions in Humans.
   Fortino SA, Wageh M, Pontello R, McGlory C, et al · · 2022 · cited 15× · PMID 35574443 · DOI 10.3389/fphys.2022.880625