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

Obesity Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Obesity
• Overweight
• Weight Loss

• NCT number: NCT05384431
• Study type: Interventional
• Source: Exerkine Corporation
• Contact: Michaela Devries-Aboud, PhD
• Phone: 9054147897
• Email: m4devrie@uwaterloo.ca
• Status: Recruiting
• Phase: Phase 3
• Start date: August 15, 2022
• Completion date: March 15, 2024