NCT05384431CompletedPhase 3
Can We Achieve 'high-quality' Weight Loss Through Supplementation and Exercise? the TRIM MUSCLE Study
Source: ClinicalTrials.gov · Last updated 8 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 51 (actual)
- First submitted
- 10 May 2022
- Start date
- 15 Aug 2022
- Primary completion date
- 20 Dec 2024
- Lead sponsor
- Exerkine Corporation
- Diseases
- Obesity
- NCT number
- NCT05384431
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 51
- From 15 Aug 2022 to the primary completion date, 20 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- liver disease (i.e. diagnosed NAFLD, NASH, cirrhosis, previous liver transplant)
- 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)
- significant weight loss in the 3-month period prior to the study (10% of total body weight)
- individuals with prior bariatric surgery
- 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.
Other illness
- GI disorders (i.e. Colitis, Crohns)
- uncontrolled hypertension (\>140/90 mmHg)
- type I or II diabetes
- history of glaucoma or
- overactive bladder syndrome
- history of allergy, sensitivity or strong dislike towards any component of the study products (supplements)
Lab values
- renal disease (creatinine \> 140)
- 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).
Age
- 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
Other
- severe osteoarthritis
- muscular dystrophy
- severe peripheral neuropathy
- severe osteoporosis
- orthopedic problems
- women who have ammenorrhea, dysregulated menstrual cycle, are peri-menopausal, menopausal, pregnant, looking to become pregnant, or nursing
- inability to take part in the exercise program
- vegan
- smoking
- consumption of more than 10 drinks/week or 2 drinks/d for women and 15 drinks/week or 3 drinks/d for men.
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Michaela Devries-Aboud Coordinator of this site? Confirm its status | Waterloo | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.