NCT03395262已完成不适用
An Examination of a Novel Weight Loss Formula on Anthropometry and Indices of Cardiovascular Disease Risk
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Body Composition - Fat Mass
研究概览
简要总结
The aim of this study is to examine a novel weight loss formula with and without common stimulants on anthropometry and indices of cardiovascular disease risk.
详细描述
Obesity remains a problem for overall health and risk for cardiovascular disease worldwide. While dietary modification and increased levels of physical activity remain steadfast recommendations, alternative strategies related to supplementation remain an interest for the general populace and medical communities. A potential objection to the use of dietary supplements is that they often contain stimulants designed to increase metabolism. However, consumers and health practitioners alike are wary of such formulae; hence, the continued investigation of non-stimulant supplements is warranted. Therefore the aim of this study is to examine a novel weight loss formula with and without common stimulants on anthropometry and indices of cardiovascular disease risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) between 25 and 34.9
排除标准
- •Recent history of weight change (+/- 10 lbs. within the past 3 months)
- •Uncontrolled metabolic disorders
- •Uncontrolled cardiovascular disorders
- •Currently taking prescription medications (birth control is allowed)
- •Currently taking dietary supplements for weight loss
- •Pregnant or plan to become pregnant
- •Have an intolerance to caffeine or other natural stimulants
研究组 & 干预措施
Active with caffeine
Experimental
Novel formula with caffeine
干预措施: Active with caffeine (Dietary Supplement)
Active without caffeine
Active Comparator
Novel formula without caffeine
干预措施: Active without caffeine (Dietary Supplement)
Placebo
Placebo Comparator
Dextrose
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Body Composition - Fat Mass
时间窗: Measured every 4 weeks for 12 weeks
Changes in fat mass (kg) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Body Composition - Weight
时间窗: Measured every 4 weeks for 12 weeks
Changes in body weight (kg) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
Body Composition - Body Fat Percent
时间窗: Measured every 4 weeks for 12 weeks
Changes in body fat (%) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).
次要结局
- Body Composition - Fat Free Mass(Measured every 4 weeks for 12 weeks)
- Body Composition - Total Body Water(Measured every 4 weeks for 12 weeks)
- Dietary Energy Intake - Carbohydrate(Measured every 4 weeks for 12 weeks)
- Resting Hemodynamics - Systolic Blood Pressure(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - Glucose Homeostasis - Blood Glucose(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - Catabolic Markers - Alanine Amino Transaminase(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - White Blood Cell Counts - Mid-Range Count(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - Red Blood Cell Counts - Hematocrit(Measured every 4 weeks for 12 weeks)
- Body Composition - Lean Tissue Mass(Measured every 4 weeks for 12 weeks)
- Body Composition - Bone Mass(Measured every 4 weeks for 12 weeks)
- Resting Energy Expenditure - Caloric Expenditure(Measured every 4 weeks for 12 weeks)
- Anthropometric Measures - Hip Circumference(Measured every 4 weeks for 12 weeks)
- Anthropometric Measures - Waist to Hip Ratio(Measured every 4 weeks for 12 weeks)
- Resting Energy Expenditure - Respiratory Exchange Ratio(Measured every 4 weeks for 12 weeks)
- Anthropometric Measures - Waist Circumference(Measured every 4 weeks for 12 weeks)
- Resting Hemodynamics - Diastolic Blood Pressure(Measured every 4 weeks for 12 weeks)
- Anthropometric Measures - Body Mass Index(Measured every 4 weeks for 12 weeks)
- Dietary Energy Intake - Total Caloric Intake(Measured every 4 weeks for 12 weeks)
- Dietary Energy Intake - Fat(Measured every 4 weeks for 12 weeks)
- Resting Hemodynamics - Heart Rate(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - Glucose Homeostasis - Fasting Insulin(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - Glucose Homeostasis - Homeostatic Model Assessment of Insulin Resistance(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - Lipid Profile - Total Cholesterol(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - Lipid Profile - Total Cholesterol to HDL Ratio(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - Catabolic Markers - Creatinine(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - Catabolic Markers - Blood Urea Nitrogen(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - White Blood Cell Counts - White Blood Cells(Measured every 4 weeks for 12 weeks)
- Dietary Energy Intake - Protein(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - Lipid Profile - Triglyderides(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - Lipid Profile - High Density Lipoproteins(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - Lipid Profile - Low Density Lipoproteins(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - Catabolic Markers - Blood Urea Nitrogen to Creatinine Ratio(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - Catabolic Markers - Alkaline Phosphatase(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - Catabolic Markers - Creatine Kinase(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - Catabolic Markers - Lactate Dehydrogenase(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - Catabolic Markers - Aspartate Amino Transaminase(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular Volume(Measured every 4 weeks for 12 weeks)
- International Physical Activity Questionnaire (IPAQ) - Total Physical Activity Score(Measured every 4 weeks for 12 weeks)
- Satiety Questionnaire - Perceptions of Hunger(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - White Blood Cell Counts - Lymphocytes(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - White Blood Cell Counts - Granulocyte(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - Red Blood Cell Counts - Red Cells(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - Red Blood Cell Counts - Hemoglobin(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular Hemoglobin(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular Hemoglobin Concentration(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - Appetite Hormone - Leptin(Measured every 4 weeks for 12 weeks)
- International Physical Activity Questionnaire (IPAQ) - Work Domain(Measured every 4 weeks for 12 weeks)
- Satiety Questionnaire - Perceptions of Appetite(Measured every 4 weeks for 12 weeks)
- Satiety Questionnaire - Perceptions of Feelings of Fullness(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - Red Blood Cell Counts - Red Cell Distribution Width(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - Red Blood Cell Counts - Platelet Count(Measured every 4 weeks for 12 weeks)
- Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Platelet Volume(Measured every 4 weeks for 12 weeks)
- International Physical Activity Questionnaire (IPAQ) - Active Transportation Domain(Measured every 4 weeks for 12 weeks)
- International Physical Activity Questionnaire (IPAQ) - Domestic and Garden/Yard Work Domain(Measured every 4 weeks for 12 weeks)
- International Physical Activity Questionnaire (IPAQ) - Leisure-Time Domain(Measured every 4 weeks for 12 weeks)
- Satiety Questionnaire - Perceptions of Satisfaction with Food(Measured every 4 weeks for 12 weeks)
- Sleep Quality Questionnaire - Sleep Quality(Measured every 4 weeks for 12 weeks)
- Sleep Quality Questionnaire - Enthusiasm(Measured every 4 weeks for 12 weeks)
- Perceptions of Side Effects - Other Side Effects(Measured every 4 weeks for 12 weeks)
- Satiety Questionnaire - Perceptions of Diet / Eating Satisfaction(Measured every 4 weeks for 12 weeks)
- Perceptions of Side Effects - Tachycardia(Measured every 4 weeks for 12 weeks)
- Perceptions of Side Effects - Dyspnea(Measured every 4 weeks for 12 weeks)
- Perceptions of Side Effects - Nervousness(Measured every 4 weeks for 12 weeks)
- Sleep Quality Questionnaire - Sleep Duration(Measured every 4 weeks for 12 weeks)
- Perceptions of Side Effects - Dizziness(Measured every 4 weeks for 12 weeks)
- Perceptions of Side Effects - Headache(Measured every 4 weeks for 12 weeks)
- Perceptions of Side Effects - Palpitations(Measured every 4 weeks for 12 weeks)
- Sleep Quality Questionnaire - Sleep Disturbances(Measured every 4 weeks for 12 weeks)
- Perceptions of Side Effects - Blurred Vision(Measured every 4 weeks for 12 weeks)
研究者
Richard B. Kreider
Executive Director, Human Clinical Research Facility
Texas A&M University
研究点 (2)
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