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

NCT05384431 | Completed Phase 3

• 1 other identifier: 43396
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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

Overweight; Obesity

Keywords

Overweight; Obesity; Exercise; Supplementation; Aerobic training; Resistance training; Insulin sensitivity; Sex differences; Inflammation; Oxidative stress; Weight management; Antioxidants; Protein

Outcome Measures

Primary Outcomes (7)

• Bodyweight change

  scale

  baseline 0 weeks ("pre study") to 12 weeks ("post study")

• BMI change

  Body mass index (weight/height squared)

  baseline 0 weeks ("pre study") to 12 weeks ("post study")

• Fat mass change

  body composition by DEXA

  baseline 0 weeks ("pre study") to 12 weeks ("post study")

• Lean mass change

  body composition by DEXA

  baseline 0 weeks ("pre study") to 12 weeks ("post study")

• Lean mass/fat mass (body composition index) change

  body composition by DEXA

  baseline 0 weeks ("pre study") to 12 weeks ("post study")

• Percent body fat change

  body composition by DEXA

  baseline 0 weeks ("pre study") to 12 weeks ("post study")

• Waist-to-hip ratio change

  measure tape

  baseline 0 weeks ("pre study") to 12 weeks ("post study")

Secondary Outcomes (12)

• VO2max change

  baseline 0 weeks ("pre study") to 12 weeks ("post study")

• Lower body strength change

  baseline 0 weeks ("pre study") to 12 weeks ("post study")

• Upper body strength change

  baseline 0 weeks ("pre study") to 12 weeks ("post study")

• Appendicular lean mass change

  baseline 0 weeks ("pre study") to 12 weeks ("post study")

• Insulin sensitivity change

  baseline 0 weeks ("pre study") to 12 weeks ("post study")

Other Outcomes (7)

• Perceived stress change (Perceived Stress Scale)

  baseline 0 weeks ("pre study") to 12 weeks ("post study")

• Sleep quality change (Bergen Insomnia Scale)

  baseline 0 weeks ("pre study") to 12 weeks ("post study")

• Health-related quality of life (SF 36)

  baseline 0 weeks ("pre study") to 12 weeks ("post study")

Study Arms (2)

Muscle5 and TRIM7

ACTIVE COMPARATOR

MUSCLE5 and TRIM7 natural health product supplementation Name of natural health product (brand name, generic) - MUSCLE 5, chocolate Is this a market-approved natural health product (per Health Canada)? - Yes Dose - 1 scoop Ingredients (per dose) - Whey protein isolate (24g), milk protein isolate (16g), Creatine (3g), Calcium (450mg), Vitamin D (1000 IU) Frequency of administration - Once/day Duration (e.g., six weeks) - 12 weeks Route of administration - Oral Name of natural health product (brand name, generic) - TRIM7 Is this a market-approved natural health product (as per Health Canada)? Yes Dose - 3 capsules Ingredients (per dose) - Alpha lipoic acid (200mg), CoEnzyme Q10 (100mg), beet root extract (250mg), green coffee bean extract (250mg), green tea extract (250mg), forskolin (25mg), Vitamin E (22 mg AT) Frequency of administration - Twice/day Duration (e.g., six weeks) - 12 weeks Route of administration - Oral

Dietary Supplement: Muscle5 and TRIM7; Other: Mixed exercise

Placebo

PLACEBO COMPARATOR

Placebo collagen and microcrystalline cellulose intake Placebo Control 1 (Counter to MUSCLE5) Dose - 1 scoop Ingredients (per dose) - Collagen (40g) Frequency of administration - once/day Duration - 12 weeks Route of administration - Oral Placebo Control 2 (Counter to TRIM7) Dose - 3 capsules Ingredients (per dose) - Microcrystalline cellulose (400 mg) Frequency of administration - twice/day Duration - 12 weeks Route of administration - Oral

Other: Mixed exercise

Interventions

Muscle5 and TRIM7 DIETARY_SUPPLEMENT

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

Muscle5 and TRIM7

Mixed exercise OTHER

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

Muscle5 and TRIM7; Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age 18 - 45 years
• BMI \> 25 kg/m2
• low physical activity level \< 150 min/week (\< ACSM and CSEP recommendations)
• have had two doses of the COVID-19 vaccine

You may not qualify if:

• renal disease (creatinine \> 140)
• liver disease (i.e. diagnosed NAFLD, NASH, cirrhosis, previous liver transplant)
• GI disorders (i.e. Colitis, Crohns)
• cardiovascular disease (recent myocardial infarction (\< 6 months), hypertension requiring more than 2 medications, congestive heart failure requiring more than one medication for control, unstable arrhythmia, angina previous stroke with residual hemiparesis)
• severe osteoarthritis
• significant weight loss in the 3-month period prior to the study (10% of total body weight)
• muscular dystrophy
• severe peripheral neuropathy
• severe osteoporosis
• uncontrolled hypertension (\>140/90 mmHg)
• orthopedic problems
• type I or II diabetes
• respiratory conditions (i.e. chronic pulmonary obstructive disorder), chronic obstructive pulmonary disease (FVC or FEV1 \< 70% of age predicted mean value), and asthma requiring more than two medications
• individuals with prior bariatric surgery
• women who have ammenorrhea, dysregulated menstrual cycle, are peri-menopausal, menopausal, pregnant, looking to become pregnant, or nursing

Sponsors & Collaborators

• Exerkine Corporation: lead
• University of Waterloo: collaborator

Study Sites (1)

Michaela Devries-Aboud

Waterloo, Ontario, N2L3G1, Canada

Location

MeSH Terms

Conditions

Overweight; Obesity; Motor Activity; Insulin Resistance; Inflammation

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Pathologic Processes

Study Officials

• Michaela Devries-Aboud, PhD

  Kinesiology and Health Sciences, University of Waterloo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All Exerkine and University of Waterloo research staff will be blinded to the study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, placebo controlled, parallel group design.

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 20, 2022
• Study Start: August 15, 2022
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)