Can We Achieve 'high-quality' Weight Loss Through Supplementation and Exercise? the TRIM MUSCLE Study

NCT05384431 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-01-08

No results posted yet for this study

Summary

The purpose of this study is to determine whether the combination of two dietary supplements: MUSCLE 5, which contains protein, creatine and vitamin D and TRIM 7, which contains beet extract, caffeine, coenzyme Q10, alpha lipoic acid, forskolin extract, green coffee bean extract, green tea and vitamin E, plus exercise can induce greater 'high-quality' weight loss than exercise alone in overweight and obese men and women. First, the investigators will examine whether the addition of these two supplements to a mixed exercise regime (e.g., aerobic and resistance training) induces greater improvements in typical training adaptations (aerobic capacity, upper \& lower body muscle strength, lean mass, ASM, fat mass, % body fat, and lean mass/fat mass). Secondly, the investigators will assess improvements in pro- and anti-inflammatory factors, insulin sensitivity, and blood lipids. Third, the investigators will determine effects on perceived stress, sleep quality, hair \& nail growth, and health-related quality of life. Overweight men and women will be randomized to either exercise alone or exercise plus supplement for 12 weeks. Training will include mixed exercise (aerobic and resistance) three days per week and supplements will be taken on a daily basis. Before and after the 12-week training period the investigators will assess A) Body weight, BMI, DXA outcomes (total lean mass, total body fat, % body fat, ASM, and lean mass/fat mass), waist circumference, VO2max, and upper/lower body maximal strength, B) Circulatory inflammatory factors, antioxidants, blood lipids, and oral glucose tolerance/insulin sensitivity (OGTT), C) Perceived stress, sleep quality, hair \& nail growth, and health-related quality of life and D) Overall Health Index. Benefits of the study to participants may include weight loss and improved health (irrespective of weight loss). Benefits of the study to the scientific community include improved understanding of how high-quality protein- and antioxidant-containing supplements, combined with mixed exercise, affect weight loss and overall health in men and women. Thus, the investigators will be comparing men and women to determine if the response to supplementation and exercise is similar or different between the sexes.

Conditions

Interventions

DIETARY_SUPPLEMENT

Muscle5 and TRIM7

Intake of MUSCLE 5 and TRIM 7 supplements on a daily basis for 12 weeks

OTHER

Mixed exercise

Mixed exercise (aerobic and resistance) three days per week for 12 weeks

Sponsors & Collaborators

  • University of Waterloo

    collaborator OTHER
  • Exerkine Corporation

    lead INDUSTRY

Principal Investigators

  • Michaela Devries-Aboud, PhD · Kinesiology and Health Sciences, University of Waterloo

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2024-12-20
Completion
2024-12-20

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05384431 on ClinicalTrials.gov