Status:
COMPLETED
Evaluation of a Supplement for Weight Management in Obese and Overweight Individuals
Lead Sponsor:
McMaster University
Conditions:
Overweight and Obesity
Men
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The purpose of this trial is to examine the effects of a novel, orally consumed dietary supplement (composed of naturally occurring components) on weight management and metabolic rate in individuals w...
Detailed Description
The present study is a randomized double-blind placebo controlled repeated measures design, with sampling of the cohorts on five separate occasions. Group 1: Intervention Group (n = 24) Healthy, over...
Eligibility Criteria
Inclusion
- Male or female
- overweight (BMI 25 - 29.9 kg/m2) or obese (BMI \> 30 kg/m2)
- Physically inactive (\< 1 hour of formal exercise/week)
Exclusion
- Participants will be excluded and/or released from the study if they meet any one of the following:
- Smoking
- Use of assistive walking devices (e.g., cane, or walker)
- Chronic use of analgesic or anti-inflammatory drugs
- Diabetes mellitus (more than one anti-diabetic drug)
- Cardiovascular disease (recent myocardial infarction (\< 6 months) and/or hypertension requiring more than 2 medications)
- Congestive heart failure requiring more than one medication for control
- Renal disease (creatinine \> 140)
- Previous stroke
- Active musculoskeletal injuries and/or severe osteoarthritis
- Significant weight loss in the 3-month period prior to the study
- Vegan diet
- Muscular dystrophy
- Severe peripheral neuropathy
- Severe osteoporosis
- Use medications known to affect protein metabolism (i.e. corticosteroids)
- Inability to consent
- Chronic obstructive pulmonary disease, and asthma requiring more than two medications.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2022
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT03812211
Start Date
March 1 2019
End Date
December 2 2022
Last Update
October 19 2023
Active Locations (1)
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1
McMaster University Medical Center
Hamilton, Ontario, Canada, L8N 3Z5