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

NCT03525197 | Completed

• 1 other identifier: HIREB 4449
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Skeletal Muscle Hypertrophy

Keywords

Muscle Physiology; Nutrition

Outcome Measures

Primary Outcomes (1)

• Muscle Mass and fiber cross-sectional area

  dual energy x-ray absorptiometry (DXA), ultrasound

  10 weeks

Secondary Outcomes (3)

• Satellite cell number, density, type I/type II fibre specific satellite cells and myonuclear domain

  10 weeks

• Strength

  10 weeks

• Fiber type distribution

  10 weeks

Study Arms (2)

Whey protein-based supplement

EXPERIMENTAL

Participants in the experimental condition will consume a supplement containing Whey Protein Isolate (20g) and other ingredients

Dietary Supplement: Whey protein-based supplement

Collagen protein-based supplement

ACTIVE COMPARATOR

Participants in the experimental condition will consume a supplement containing Collagen protein (20g) and other ingredients

Dietary Supplement: Collagen protein-based supplement

Interventions

Whey protein-based supplement DIETARY_SUPPLEMENT

High quality protein supplement to be consumed twice daily

Whey protein-based supplement

Collagen protein-based supplement DIETARY_SUPPLEMENT

Lower quality protein supplement to be consumed daily

Collagen protein-based supplement

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18-30 years old

You may not qualify if:

• Recreationally active (exercising \~2x/week) with some resistance training experience (no more than 2 times weekly) allowed
• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (2)

Exercise Metabolism Research Laboratory, McMaster Univeristy

Hamilton, Ontario, L8S 4K1, Canada

Location

Ivor Wynne Center

Hamilton, Ontario, L8S4K1, Canada

Location

Related Publications (10)

• Burke DG, Chilibeck PD, Davidson KS, Candow DG, Farthing J, Smith-Palmer T. The effect of whey protein supplementation with and without creatine monohydrate combined with resistance training on lean tissue mass and muscle strength. Int J Sport Nutr Exerc Metab. 2001 Sep;11(3):349-64. doi: 10.1123/ijsnem.11.3.349.

  PMID: 11591884 BACKGROUND

• 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. doi: 10.1152/ajpendo.00368.2003. Epub 2003 Oct 28.

  PMID: 14583440 BACKGROUND

• 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.

  PMID: 26864356 BACKGROUND

• 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.

  PMID: 20565767 BACKGROUND

• Coburn JW, Housh DJ, Housh TJ, Malek MH, Beck TW, Cramer JT, Johnson GO, Donlin PE. Effects of leucine and whey protein supplementation during eight weeks of unilateral resistance training. J Strength Cond Res. 2006 May;20(2):284-91. doi: 10.1519/R-17925.1.

  PMID: 16686554 BACKGROUND

• 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.

  PMID: 25156880 BACKGROUND

• 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. doi: 10.1139/H07-076.

  PMID: 18059587 BACKGROUND

• 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.

  PMID: 25646324 BACKGROUND

• Wageh M, Fortino SA, Pontello R, Maklad A, McGlory C, Kumbhare D, Phillips SM, Parise G. The Effect of Multi-Ingredient Protein versus Collagen Supplementation on Satellite Cell Properties in Males and Females. Med Sci Sports Exerc. 2024 Nov 1;56(11):2125-2134. doi: 10.1249/MSS.0000000000003505.

  PMID: 39475860 DERIVED

• Wageh M, Fortino SA, McGlory C, Kumbhare D, Phillips SM, Parise G. The Effect of a Multi-ingredient Supplement on Resistance Training-induced Adaptations. Med Sci Sports Exerc. 2021 Aug 1;53(8):1699-1707. doi: 10.1249/MSS.0000000000002641.

  PMID: 33756525 DERIVED

Study Officials

• Gianni Parise, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Stuart Phillips, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Each subject's supplement is coded with a different number, and neither the researchers nor the subjects are aware of the condition the subject is placed in.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel group design (with repeated measurements within each group)

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 15, 2018
• Study Start: September 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: July 1, 2019
• Last Updated: January 7, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)