Can we Achieve 'High-quality' Weight Loss Through Supplementation and Exercise? The TRIM MUSCLE Study

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Overweight
• Intervention / Treatment: Dietary supplement: Muscle5 and TRIM7; Other: Mixed exercise

Detailed Description

The purpose of the proposed study is to determine if the addition of two supplements (TRIM 7 and MUSCLE 5) to an exercise regime can induce more favorable effects on body weight, BMI, body composition (lean mass, fat mass, % body fat, ASM, and lean mass/fat mass), upper & lower body strength, aerobic fitness (VO2max), insulin sensitivity (OGTT), blood lipids (cholesterol and triglycerides), antioxidant capacity (total reducing capacity of plasma), inflammation (TNFα, IL6, CRP, IL- 10) and overall health in overweight men and women.

Primary objective/research question*:

-Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater 'high-quality' weight loss?

Co-primary objectives/research questions*:

• Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater loss of bodyweight?
• Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater improvement in body mass index (BMI)?
• Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater improvement in waist-to-hip ratio?
• Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater loss of fat mass?
• Can the addition of TRIM 7 and MUSCLE 5 to an exercise program maintain or improve lean mass?
• Can the addition of TRIM 7 and MUSCLE 5 to an exercise program maintain or improve lean mass/fat mass ratio (e.g., body composition index)?

Secondary objectives/research questions:

• Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater improvements in muscle strength and aerobic capacity?
• Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater improvements in insulin sensitivity?
• Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater reductions in inflammation and greater increases in antioxidant status?
• Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater improvements in sleep quality, perceived stress, health-related quality of life and the overall health index?
• Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater improvements in hair & nail growth?

Hypotheses:

• The addition of TRIM 7 and MUSCLE 5 will induce greater 'high-quality' weight loss than exercise alone as evidenced by A) greater loss of fat mass, B) greater gain (or maintenance) of lean mass, C) greater improvement in lean mass/fat mass ratio (e.g., body composition index) D) greater loss of bodyweight E) greater reduction in waist-to-hip ratio and/or F) greater improvement in BMI.
• The addition of TRIM 7 and MUSCLE 5 will induce greater improvements in muscle strength and aerobic fitness than exercise alone as evidenced by a greater improvement in 1RM and VO2peak than exercise alone.
• The addition of TRIM 7 and MUSCLE 5 will induce greater improvements in insulin sensitivity (HOMA-IR, glycemic control during an OGTT, Matsuda Index) than exercise alone.
• The addition of TRIM 7 and MUSCLE 5 will induce a greater reduction in inflammation (TNFα, IL6, CRP, IL- 10) and induce a greater improvement in antioxidant status (GSH:GSSG, CuZn SOD, MnSOD, catalase, total reducing capacity of plasma) than exercise alone.
• The addition of TRIM 7 and MUSCLE 5 will induce greater improvements in sleep quality, perceived stress, health-related quality of life, and an overall health index than exercise alone.
• The addition of TRIM 7 and MUSCLE 5 will induce greater improvements in hair & nail growth than exercise alone.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Michaela Devries-Aboud, PhD; Phone Number: 9054147897; Email: m4devrie@uwaterloo.ca
• Study Contact Backup: Name: Jennifer Wilkinson; Phone Number: 9054147897; Email: j7wilkin@uwaterloo.ca

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L3G1
      • Recruiting
      • Michaela Devries-Aboud
      • Contact: Michaela Devries-Aboud; Phone Number: 9054147897; Email: m4devrie@uwaterloo.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• medications, including anti-inflammatory medications, more than one glucose lowering medication, insulin, platelet inhibitors, anti-coagulant medications, or Simvastatin (zocor), beta-blockers, or weight loss medications (Orlistat, Saxenda Contrave) or any other medications known to affect protein metabolism (i.e.corticosteroids).
• inability to take part in the exercise program
• vegan
• smoking
• history of glaucoma or
• overactive bladder syndrome
• consumption of more than 10 drinks/week or 2 drinks/d for women and 15 drinks/week or 3 drinks/d for men.
• history of allergy, sensitivity or strong dislike towards any component of the study products (supplements)
• have undergone a barium swallow or an infusion of a contrast agent in the past 3 weeks
• have an implantable electronic device
• inability to perform exercise as determined by the Get Active Questionnaire (GAQ)
• inability to consent
• participants on volitional dietary supplements will be considered on a case-by-case basis, but they will be asked to refrain from intake for at least 2 weeks prior to partaking in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Muscle5 and TRIM7; 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; 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
Placebo Comparator: Placebo; 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; Mixed exercise (aerobic and resistance) three days per week for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2max change	Maximal aerobic capacity test (gas exchange and indirect calorimetry measured using a metabolic cart and incremental cycle ergometry)	baseline 0 weeks ("pre study") to 12 weeks ("post study")
Lower body strength change	1-repetition and 5-repetition maximal strength	baseline 0 weeks ("pre study") to 12 weeks ("post study")
Upper body strength change	1-repitition maximal strength and 5-repeitition maximal strength	baseline 0 weeks ("pre study") to 12 weeks ("post study")
Appendicular lean mass change	body composition by DEXA	baseline 0 weeks ("pre study") to 12 weeks ("post study")
Insulin sensitivity change	Oral glucose tolerance test (OGTT)	baseline 0 weeks ("pre study") to 12 weeks ("post study")
Blood lipids change	cholesterol (LDL, HDL, and total cholesterol) and triglycerides	baseline 0 weeks ("pre study") to 12 weeks ("post study")
Inflammation CRP change	pro-inflammatory circulatory factor (ng/mL) by Luminex Performance Assay	baseline 0 weeks ("pre study") to 12 weeks ("post study")
Inflammation TNF-alpha change	pro inflammatory circulatory factor (pg/ml) by Luminex Performance Assay	baseline 0 weeks ("pre study") to 12 weeks ("post study")
Inflammation IL-1 change	pro inflammatory circulatory factor (pg/ml) by Luminex Performance Assay	baseline 0 weeks ("pre study") to 12 weeks ("post study")
Inflammation IL-10 change	anti-inflammatory circulatory factors (pg/mL) by Luminex Performance Assay	baseline 0 weeks ("pre study") to 12 weeks ("post study")
Inflammation IL-6 change	pro-inflammatory circulatory factor (pg/mL) by Luminex Performance Assay	baseline 0 weeks ("pre study") to 12 weeks ("post study")
Antioxidant capacity change	TEAC (trolox equivalent antioxidant assay)	baseline 0 weeks ("pre study") to 12 weeks ("post study")

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived stress change (Perceived Stress Scale)	Perceived Stress Scale (PSS-10; 0 = lowest stress, 40 = highest stress)	baseline 0 weeks ("pre study") to 12 weeks ("post study")
Sleep quality change (Bergen Insomnia Scale)	Bergen Insomnia Scale (0 = lowest insomnia, 42 = highest insomnia)	baseline 0 weeks ("pre study") to 12 weeks ("post study")
Health-related quality of life (SF 36)	36 Item Short Form Survey (SF 36; 0 = maximal disability, 100 = no disability)	baseline 0 weeks ("pre study") to 12 weeks ("post study")
Male hair growth & quality (Merk & Co, 1996)	5 item survey (Merk & Co; 38 = maximal score (highest quality), 5 = lowest score (lowest quality))	baseline 0 weeks ("pre study") to 12 weeks ("post study")
Female hair growth & quality (WHGQ)	4 item survey (WHGQ; 28 = maximal score (highest quality), 4 = lowest score (lowest quality))	baseline 0 weeks ("pre study") to 12 weeks ("post study")
Nail health	5 item survey (25 = maximal score, 5 = lowest score)	baseline 0 weeks ("pre study") to 12 weeks ("post study")
Nail growth change	Ten-day nail growth will be measured by a digital caliper (Mitotoyu 500) three times during the course of the study (baseline, midway, and post).	baseline 0 weeks ("pre study"), 6 weeks ("midway"), and 12 weeks ("post study")

Collaborators and Investigators

• Sponsor: Exerkine Corporation
• Collaborators: University of Waterloo
• Investigators: Principal Investigator: Michaela Devries-Aboud, PhD, Kinesiology and Health Sciences, University of Waterloo

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Estimated): March 15, 2024
• Study Completion (Estimated): March 15, 2024

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 20, 2022

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Antioxidants; Oxidative stress; Inflammation; Exercise; Obesity; Supplementation; Overweight; Aerobic training; Insulin sensitivity; Protein; Resistance training; Weight management; Sex differences
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: 43396

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plans of making the clinical trial data at the individual level available to researchers who were not part of the original study team

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No