Clinical trial NCT05384431: Can We Achieve 'high-quality' Weight Loss Through Supplementation and Exercise? the TRIM MUSCLE Study
Official title: Can We Achieve 'high-quality' Weight Loss Through Supplementation and Exercise? the TRIM MUSCLE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overweight
Obesity
Keywords: Overweight
Obesity
Exercise
Supplementation
Aerobic training
Resistance training
Insulin sensitivity
Sex differences
Inflammation
Oxidative stress
Weight management
Antioxidants
Protein
Lead sponsor: Exerkine Corporation
Sponsor class: INDUSTRY
Collaborators: name: University of Waterloo
First posted: 2022-05-20
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo controlled, parallel group design.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bodyweight change
timeFrame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
measure: BMI change
timeFrame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
measure: Fat mass change
timeFrame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
measure: Lean mass change
timeFrame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
measure: Lean mass/fat mass (body composition index) change
timeFrame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
measure: Percent body fat change
timeFrame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
measure: Waist-to-hip ratio change
timeFrame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Secondary outcomes:
measure: VO2max change
timeFrame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
measure: Lower body strength change
timeFrame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
measure: Upper body strength change
timeFrame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
measure: Appendicular lean mass change
timeFrame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
measure: Insulin sensitivity change
timeFrame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
measure: Blood lipids change
timeFrame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
measure: Inflammation CRP change
timeFrame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
measure: Inflammation TNF-alpha change
timeFrame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
measure: Inflammation IL-1 change
timeFrame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
measure: Inflammation IL-10 change
timeFrame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
measure: Inflammation IL-6 change
timeFrame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
measure: Antioxidant capacity change
timeFrame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Other outcomes:
measure: Perceived stress change (Perceived Stress Scale)
timeFrame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
measure: Sleep quality change (Bergen Insomnia Scale)
timeFrame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
measure: Health-related quality of life (SF 36)
timeFrame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
measure: Male hair growth & quality (Merk & Co, 1996)
timeFrame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
measure: Female hair growth & quality (WHGQ)
timeFrame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
measure: Nail health
timeFrame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
measure: Nail growth change
timeFrame: baseline 0 weeks ("pre study"), 6 weeks ("midway"), and 12 weeks ("post study")
Locations:
city: Waterloo
country: Canada
facility: Michaela Devries-Aboud
state: Ontario
Study officials:
affiliation: Kinesiology and Health Sciences, University of Waterloo
name: Michaela Devries-Aboud, PhD
role: PRINCIPAL_INVESTIGATOR
References: