Status:
COMPLETED
Can We Achieve 'high-quality' Weight Loss Through Supplementation and Exercise? the TRIM MUSCLE Study
Lead Sponsor:
Exerkine Corporation
Collaborating Sponsors:
University of Waterloo
Conditions:
Overweight
Obesity
Eligibility:
All Genders
18-45 years
Phase:
PHASE3
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2024
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT05384431
Start Date
August 15 2022
End Date
December 20 2024
Last Update
January 8 2025
Active Locations (1)
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1
Michaela Devries-Aboud
Waterloo, Ontario, Canada, N2L3G1