A Comparative Effectiveness Study Evaluating the Effects of Two Thermogenic Supplements on Body Composition Using a Double-Blinded Placebo-Controlled Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Body Composition (fat, fat-free mass and bone mineral density) as measured by Dual Energy X-ray Absorptiometry (DXA)
研究概览
简要总结
The purpose of this study is to determine whether subjects taking a supplement designed to increase metabolic rate will have a positive effect on body composition (fat mass, muscle mass, and bone density.)
详细描述
In a previous randomized double-blinded placebo-controlled pilot study, subjects taking the nutritional supplements contained in these two weight loss plans had a short-term statistically significant increase in their resting metabolic rates as compared to taking a placebo. No increases were found in blood pressure, resting heart rate, or self-reported discomfort when taking the supplement.
The current study was designed to extend the findings of the pilot study over a 60-day study period using a randomized double-blinded placebo-controlled protocol with the same weight loss interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must ensure with medical provider that there are no medical conditions that would preclude participation
- •Must be able to swallow capsules
- •Must be age 21 or above
排除标准
- •Pregnant or breast feeding
研究组 & 干预措施
Advantra Z
Proprietary ingredient for: stimulating thermogenesis, reducing weight, increasing lean muscle mass to total body mass, improving athletic performance, and suppressing appetite
干预措施: Advantra Z (Dietary Supplement)
Advantra Z + Naringin + Hesperiden
干预措施: Advantra Z + Naringin + Hesperiden (Dietary Supplement)
Sugar pill
Capsule contains inert ingredient.
干预措施: Sugar pill (Other)
结局指标
主要结局
Body Composition (fat, fat-free mass and bone mineral density) as measured by Dual Energy X-ray Absorptiometry (DXA)
时间窗: 0 and 60 days
This study goes beyond assessing changes in scale weight and BMI. DXA is used to assess changes in body composition (lean, fat and bone) associated with the weight loss interventions.
次要结局
- 43-item blood chemistry panel(0 and 60 days)
- Change from Baseline in Systolic and Diastolic Blood Pressure at 30 days(0 and 30 days)
- Change from Baseline in Resting Heart Rate at 30 days(0 and 30 days)
- Change from midpoint of study in Resting Heart Rate at 60 days(30 and 60 days)
- Change from Baseline in Systolic and Diastolic Blood Pressure at 60 days(0 and 60 days)
- Change from Baseline in Resting Heart Rate at 60 days(0 and 60 days)
- Change from Baseline in self-reported quality of life at 30 days.(0 and 30 days)
- Change from mid-point of study in self-reported quality of life at 60 days.(30 and 60 days)
- Change from Baseline in self-reported quality of life at 60 days.(0 and 60 days)
- Change from Baseline in self-reported eating behavior at 30 days.(0 and 30 days)
- Change from mid-point of study in self-reported eating behavior at 60 days(30 and 60 days)
- Change from Baseline in self-reported eating behavior at 60 days.(0 and 60 days)
- Change from mid-point of study in Systolic and Diastolic Blood Pressure at 60 days(30 and 60 days)
- Number of participants with adverse events(up to 60 days)
研究者
Gilbert R Kaats
Dr. Gilbert R. Kaats, PhD
Integrative Health Technologies, Inc.