Mixed Exercise Training and Novel Multi-Nutrient Supplementation in Young Adults

NCT06231069 | Withdrawn DMC

• 1 other identifier: 7405
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to elucidate the effects of 12 weeks of novel multi-nutrient supplementation combined with mixed aerobic/resistance exercise training on skeletal muscle function in young adults. It is hypothesized that multi-nutrient supplementation and mixed aerobic/resistance exercise training (AET/RET) will have interactive effects on muscle fitness.

Conditions

Sarcopenia

Keywords

Muscle

Outcome Measures

Primary Outcomes (6)

• Percent change in DXA-obtained muscle mass

  Pre to post change in DXA-obtained muscle mass (%)

  12 weeks

• Percent change in DXA-obtained fat mass

  Pre to post change in DXA-obtained fat mass (%)

  12 weeks

• Percent change in DXA-obtained muscle mass to fat mass ratio

  Pre to post change in DXA-obtained muscle mass to fat mass ratio (%)

  12 weeks

• Percent change in bodyweight

  Pre to post change in bodyweight (%)

  12 weeks

• Percent change in body mass index

  Pre to post change in body mass index (%)

  12 weeks

• Percent change in waist to hip ratio

  Pre to post change in waist to hip ratio (%)

  12 weeks

Secondary Outcomes (9)

• Percent change in slow muscle fiber areas

  12 weeks

• Percent change in fast muscle fiber areas of quadriceps

  12 weeks

• Percent change in quadriceps circumference

  12 weeks

• Percent change in essential amino acid blood levels

  12 weeks

• Percent change in inflammatory cytokine blood levels (interluekins)

  12 weeks

Study Arms (2)

Multi-nutrient supplementation during training

EXPERIMENTAL

Dietary Supplement: Multi-nutrient supplement; Other: Exercise

Placebo during training

PLACEBO COMPARATOR

Other: Exercise

Interventions

Multi-nutrient supplement DIETARY_SUPPLEMENT

12 weeks of supplement intake of milk proteins, N-3 PUFAs, creatine, and vitamin D at levels previously shown to augment muscle protein synthesis in young individuals.

Multi-nutrient supplementation during training

Exercise OTHER

12 weeks of short-duration mixed endurance and resistance exercise.

Multi-nutrient supplementation during training; Placebo during training

Eligibility Criteria

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

You may qualify if:

• non-smoking
• non-diabetic
• apparently healthy
• minimally recreationally active
• males and females aged 18-30 years

You may not qualify if:

• pregnancy
• breast feeding
• smoking
• obesity
• diabetes mellitus
• cardiovascular disease (recent myocardial infarction (≤ 6 months)
• hypertension requiring more than 2 medications
• congestive heart failure requiring more than one medication,
• renal disease (creatinine \> 130),
• previous stroke with residual hemiparesis,
• active musculoskeletal injuries and/or severe osteoarthritis,
• significant weight loss in the 3-month period prior to the study,
• vegan diet,
• dairy protein allergy,
• muscular dystrophy,

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University Medical Center

Hamilton, Ontario, L8N 3Z5, Canada

Location

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 A Tarnopolsky, 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: Following stratification (balanced by age, gender, dietary patterns, and PA levels), randomization into supplement vs. placebo groups will be done by an outside party. Thereafter, GCP (good clinical practice)-certified research coordinators will administer the supplements and collect the baseline/post data in a blinded fashion. These data will be locked and the code for randomization will not be broken until the study is completed. The integrity of the data and the quality of the data analyses will be verified by an outside source. Compliance to GCP will be checked regularly throughout the study period.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The present study is a randomized, double-blind, placebo-controlled 12-week mixed training and supplementation study (placebo vs. active supplement), with data collection occurring at several different time-points (pre, mid, and post) in young males and females (18-30 years of age).

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: January 30, 2024
• Study Start (Estimated): January 20, 2030
• Primary Completion (Estimated): April 20, 2030
• Study Completion (Estimated): December 15, 2030
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)