Evaluation of a Supplement for Weight Management in Obese and Overweight Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Body mass index
研究概览
简要总结
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.
详细描述
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, overweight or obese physically inactive males, supplement, n = 12 Healthy, overweight or obese physically inactive females, supplement, n=12 Group 2: Placebo Group (n = 24) Healthy, overweight or obese physically inactive males, no supplement, n = 12 Healthy, overweight or obese physically inactive females, no supplement, n=12
Participants will be asked to make 5 visits.
Day 0 (Visit 1): Eligible participants that provided informed consent will complete a medical screening questionnaire to determine their readiness to perform exercise. Participants will thus complete the SF-36 and CSEP Get Active Questionnaire form. Participant characteristics will then be measured. At this time, anthropometric measurements (i.e., height, weight, waist circumference) and a dual energy x-ray absorptiometry (DXA) measurement will be performed. This must be done in order to verify that the participant meets the inclusion criteria of being overweight. Following this screening, participants will begin the following the study timeline.Upon completion, participants will be randomized into one of two groups.
Day 1 (Visit 2): Participants will arrive following an overnight fast (including no caffeine for 12 hours) and having abstained from any exercise for the prior 48 hours. Participants will enter the clinic, and rest quietly in the supine position for 25 minutes before having blood pressure with a non-invasive automated cuff and resting metabolic rate via metabolic cart measured. Following resting blood pressure and baseline metabolic rate assessment, blood will be drawn from an antecubital vein. Thereafter, functional metrics will be determined including strength (both upper and lower body muscles; and aerobic capacity (V02peak). Following testing, participants will be provided with a 3-day diet log (which will be completed every two weeks) and a pedometer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •overweight (BMI 25 - 29.9 kg/m2) or obese (BMI > 30 kg/m2)
- •Physically inactive (< 1 hour of formal exercise/week)
排除标准
- •Participants will be excluded and/or released from the study if they meet any one of the following:
- •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.
研究组 & 干预措施
Active Supplement
Participants will be allocated in a randomized, double-masked manner to receive a multi-faceted supplement for the 12-week duration of the study
干预措施: Active Supplement (Dietary Supplement)
Placebo
Participants will be allocated in a randomized, double-masked manner to receive a placebo supplement (the placebo will be made of microcrystalline cellulose, and will be matched in size, appearance, taste and caloric value) for the 12-week duration of the study
干预措施: Placebo supplement (Dietary Supplement)
结局指标
主要结局
Body mass index
时间窗: 12 weeks
Measure of body fat based on height and weight that applies to adult men and women
Body composition
时间窗: 12 weeks
Fat free mass and fat mass measured via DXA
次要结局
- Fuel source utilization(12 weeks)
- Muscle strength(12 weeks)
- Hemaglobin A1C in mmol/mol(12 weeks)
- Aerobic fitness(12 weeks)
- Blood pressure(12 weeks)
- Anthropometric measurements(12 weeks)
- Concentration of insulin in the blood(12 weeks)
- Concentration of lipids in the blood(12 weeks)
- Quality of Life rating(12 weeks)
研究者
Mark Tarnopolsky
Principal Investigator, Professor, Director of Neuromuscular and Neurometabolic Clinic
McMaster University