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

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.

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.