Exercise and Nutritional Supplementation

NCT03536871 | Completed DMC

• 1 other identifier: 4656
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

To understand the effects of a novel dietary supplement when used in conjunction with a healthy lifestyle exercise program and to define biomarkers that are specific to sarcopenia. A primary aim in the present study is to determine whether a relationship exists between positive changes in body composition through increases in lean mass and reductions in body fat following oral supplementation of naturally occurring food components in combination with exercise. The purpose of the present study is to examine the effects of a multi-nutrient supplement in combination with an endurance and resistance based exercise intervention in a cohort of older adult men with varying degrees of sarcopenia as compared to younger male controls (McMaster/CIHR/Exerkine project). A sub-purpose nested within the study is to provide serum and muscle samples for use in an aging/sarcopenia biomarker discovery study taken at pre-intervention for the young and older men (Buck Institute/Astellas project).

Conditions

Sarcopenia; Healthy Elderly; Healthy Young

Outcome Measures

Primary Outcomes (3)

• Body Composition

  Fat-Free and Fat Mass

  12 weeks

• Muscle Strength

  Knee extension isometric strength and leg press

  12 weeks

• Functional Outcomes

  6 Minute Walk Test

  12 weeks

Secondary Outcomes (6)

• Mitochondrial Function

  12 weeks

• Muscle Fibre Size

  12 weeks

• Inflammatory markers

  12 weeks

• Quality of Life assessment

  12 weeks

• Glycemia measurements

  12 weeks

Study Arms (4)

Multinutrient Supplement

ACTIVE COMPARATOR

Participants will be allocated in a randomized double-masked manner to receive a multi-nutrient supplement (protein and creatine sachet and omega-3 oil) or placebo during a 12 week home-based exercise program and we will assess the influence on the primary and secondary outcomes.

Dietary Supplement: multi-nutrient supplement

Age biological and chronological

NO INTERVENTION

The primary and secondary outcomes will be compared between the younger and older age groups as a function of both exercise and nutritional supplementation.

Sarcopenia grades

NO INTERVENTION

The baseline primary and secondary outcomes will be compared for each of the 3 older adults males groups as a function of muscle mass (healthy active, mild sarcopenia and moderate sarcopenia).

Exercise - home based programme

EXPERIMENTAL

Each of the older participants will undergo a 12 week home-based exercise program (endurance = increased steps; resistance = body weight and elastic band exercise) to determine the effects on the primary and secondary outcomes.

Other: Exercise

Interventions

multi-nutrient supplement DIETARY_SUPPLEMENT

Compare the effects of a multi-nutrient supplement following a healthy lifestyles program in healthy young men and women, healthy older men, and sarcopenic older men.

Multinutrient Supplement

Exercise OTHER

We will evaluate the effect of 12 weeks of combined endurance and resistance home-based exercise in younger and older adults.

Exercise - home based programme

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inactive younger men (\< 1 hour of formal exercise/week) in the overweight BMI category (25 - 29.9 kg/m2).
• Healthy older male participants will have a body mass index \< 30 kg/m2, muscle mass index \> 7.23 kg/m2, and a 4-meter walk test \> 0.8 m/s.
• Men in the older adult "sarcopenia" group will be individuals that have a body mass index \< 30 kg/m2, a muscle mass index between 8.51-10.75 kg/m2, and a 4-meter walk test \< 0.8m/s.

You may not qualify if:

• Current smokers
• On more than one anti-diabetic drug
• Cardiovascular disease (myocardial infarction and/or hypertension requiring more than 2 medications)
• Congestive heart failure
• Renal disease (creatinine \> 130)
• Previous stroke
• Hypertension requiring more than two-pharmacological agents
• Active musculoskeletal injuries and/or severe osteoarthritis
• Significant weight loss in the 3-month period prior to the study
• Vegan diet
• Dairy protein allergy
• History of muscle and/or bone wasting diseases
• Concurrent medications known to affect protein metabolism (i.e. corticosteroids, or prescription strength acne medications)
• Inability to consent
• Chronic obstructive pulmonary disease (FVC or FEV1 \< 80% of age predicted mean value or requiring any medication other than a puffer as needed)

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University Medical Center

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (7)

• Brose A, Parise G, Tarnopolsky MA. Creatine supplementation enhances isometric strength and body composition improvements following strength exercise training in older adults. J Gerontol A Biol Sci Med Sci. 2003 Jan;58(1):11-9. doi: 10.1093/gerona/58.1.b11.

  PMID: 12560406 RESULT

• Tarnopolsky M, Zimmer A, Paikin J, Safdar A, Aboud A, Pearce E, Roy B, Doherty T. Creatine monohydrate and conjugated linoleic acid improve strength and body composition following resistance exercise in older adults. PLoS One. 2007 Oct 3;2(10):e991. doi: 10.1371/journal.pone.0000991.

  PMID: 17912368 RESULT

• Bell KE, Snijders T, Zulyniak M, Kumbhare D, Parise G, Chabowski A, Phillips SM. A whey protein-based multi-ingredient nutritional supplement stimulates gains in lean body mass and strength in healthy older men: A randomized controlled trial. PLoS One. 2017 Jul 18;12(7):e0181387. doi: 10.1371/journal.pone.0181387. eCollection 2017.

  PMID: 28719669 RESULT

• Murphy CH, Saddler NI, Devries MC, McGlory C, Baker SK, Phillips SM. Leucine supplementation enhances integrative myofibrillar protein synthesis in free-living older men consuming lower- and higher-protein diets: a parallel-group crossover study. Am J Clin Nutr. 2016 Dec;104(6):1594-1606. doi: 10.3945/ajcn.116.136424. Epub 2016 Nov 9.

  PMID: 27935521 RESULT

• Churchward-Venne TA, Breen L, Di Donato DM, Hector AJ, Mitchell CJ, Moore DR, Stellingwerff T, Breuille D, Offord EA, Baker SK, Phillips SM. Leucine supplementation of a low-protein mixed macronutrient beverage enhances myofibrillar protein synthesis in young men: a double-blind, randomized trial. Am J Clin Nutr. 2014 Feb;99(2):276-86. doi: 10.3945/ajcn.113.068775. Epub 2013 Nov 27.

  PMID: 24284442 RESULT

• Nilsson MI, Mikhail A, Lan L, Di Carlo A, Hamilton B, Barnard K, Hettinga BP, Hatcher E, Tarnopolsky MG, Nederveen JP, Bujak AL, May L, Tarnopolsky MA. A Five-Ingredient Nutritional Supplement and Home-Based Resistance Exercise Improve Lean Mass and Strength in Free-Living Elderly. Nutrients. 2020 Aug 10;12(8):2391. doi: 10.3390/nu12082391.

  PMID: 32785021 RESULT

• Perez K, Ciotlos S, McGirr J, Limbad C, Doi R, Nederveen JP, Nilsson MI, Winer DA, Evans W, Tarnopolsky M, Campisi J, Melov S. Single nuclei profiling identifies cell specific markers of skeletal muscle aging, frailty, and senescence. Aging (Albany NY). 2022 Dec 13;14(23):9393-9422. doi: 10.18632/aging.204435. Epub 2022 Dec 13.

  PMID: 36516485 RESULT

Related Links

• Pubmed link primary publication (Nilsson et al.)
• Pubmed link to aging biomarker publication (Perez et al.)

MeSH Terms

Conditions

Sarcopenia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mark Tarnopololsky, MD/PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The nutritional supplement will be delivered to a 3rd party contract research organization and the allocation will only be un-blinded after data lock.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor, Director of Neuromuscular and Neurometabolic Clinic

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: May 25, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)