Overweight and Obesity Clinical Trial
Official title:
Evaluation of a Supplement for Weight Management in Obese and Overweight Individuals
NCT number | NCT03812211 |
Other study ID # | 5754 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2019 |
Est. completion date | December 2, 2022 |
Verified date | October 2023 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 who are overweight or obese following a 12-week supplementation period. The investigator's primary outcome will be changes in body composition measured via dual energy x-ray absorptiometry (DXA), which will measure changes in fat and lean mass during the supplementation period. Another primary objective will be to determine whether or not the body mass index (BMI) changes during the supplementation period. A secondary objective of the study is to determine whether anthropometric measurements (waist-to-hip ratio) is altered following the supplementation period. Another secondary objective of this study is to determine whether metabolic rate (as measured in VO2 consumption at rest and during exercise) is changed following the supplementation period. Another secondary objective is to determine whether blood pressure (systolic and diastolic pressure, measured in mm Hg) and physical function (measured via VO2peak in mL/min/kg-1 and leg strength in kilograms) change when the supplement is administered over a 12-week period. Another secondary objective will determine how glycemic control, blood markers of inflammation and cholesterol are affected by this intervention.
Status | Completed |
Enrollment | 65 |
Est. completion date | December 2, 2022 |
Est. primary completion date | April 24, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
Canada | McMaster University Medical Center | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University |
Canada,
Bailey SJ, Winyard P, Vanhatalo A, Blackwell JR, Dimenna FJ, Wilkerson DP, Tarr J, Benjamin N, Jones AM. Dietary nitrate supplementation reduces the O2 cost of low-intensity exercise and enhances tolerance to high-intensity exercise in humans. J Appl Physiol (1985). 2009 Oct;107(4):1144-55. doi: 10.1152/japplphysiol.00722.2009. Epub 2009 Aug 6. — View Citation
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Maki KC, Reeves MS, Farmer M, Yasunaga K, Matsuo N, Katsuragi Y, Komikado M, Tokimitsu I, Wilder D, Jones F, Blumberg JB, Cartwright Y. Green tea catechin consumption enhances exercise-induced abdominal fat loss in overweight and obese adults. J Nutr. 2009 Feb;139(2):264-70. doi: 10.3945/jn.108.098293. Epub 2008 Dec 11. — View Citation
Rasool AH, Yuen KH, Yusoff K, Wong AR, Rahman AR. Dose dependent elevation of plasma tocotrienol levels and its effect on arterial compliance, plasma total antioxidant status, and lipid profile in healthy humans supplemented with tocotrienol rich vitamin E. J Nutr Sci Vitaminol (Tokyo). 2006 Dec;52(6):473-8. doi: 10.3177/jnsv.52.473. — View Citation
Thom E. The effect of chlorogenic acid enriched coffee on glucose absorption in healthy volunteers and its effect on body mass when used long-term in overweight and obese people. J Int Med Res. 2007 Nov-Dec;35(6):900-8. doi: 10.1177/147323000703500620. — View Citation
Zembron-Lacny A, Slowinska-Lisowska M, Szygula Z, Witkowski K, Stefaniak T, Dziubek W. Assessment of the antioxidant effectiveness of alpha-lipoic acid in healthy men exposed to muscle-damaging exercise. J Physiol Pharmacol. 2009 Jun;60(2):139-43. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body composition | Fat free mass and fat mass measured via DXA | 12 weeks | |
Primary | Body mass index | Measure of body fat based on height and weight that applies to adult men and women | 12 weeks | |
Secondary | Blood pressure | systolic and diastolic pressure, measured in mm Hg | 12 weeks | |
Secondary | Muscle strength | Leg strength measured via Biodex | 12 weeks | |
Secondary | Aerobic fitness | VO2peak in mL/min/kg-1 | 12 weeks | |
Secondary | Fuel source utilization | Consumed O2 compared to expired CO2 | 12 weeks | |
Secondary | Hemaglobin A1C in mmol/mol | Amount of glycated hemoglobin | 12 weeks | |
Secondary | Concentration of insulin in the blood | Measures the amount of insulin in the blood. | 12 weeks | |
Secondary | Concentration of lipids in the blood | Cholesterol, low density lipoprotein, high density lipoprotein, triglycerides in the blood | 12 weeks | |
Secondary | Quality of Life rating | RAND SF(short form health survey)-36 Questionnaire; The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability | 12 weeks | |
Secondary | Anthropometric measurements | Waist-to-hip ratio measurements (in cm) | 12 weeks |
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