Impact of Active Nutrition Program on Weight Loss and Associated Measures of Health in Overweight and Obese Men and Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Resting Heart Rate
研究概览
简要总结
The study will evaluate the impact of the Active Nutrition 60-day program from USANA on weight loss and related measures, such as body composition, physical appearance/body shape, perceived wellness, and biochemical markers of health (e.g., blood lipids, glucose, insulin).
详细描述
To date, no controlled study exists to evaluate the impact of the Active Nutrition program from USANA on weight loss and related measures, such as body composition, physical appearance/body shape, perceived wellness, and biochemical markers of health (e.g., blood lipids, glucose, insulin). Therefore, the purpose of the proposed study is to evaluate the Active Nutrition weight loss program on body weight and related variables in a sample of overweight and obese men and women. Subjects in the Active Nutrition group will be compared to a control group of men and women following their standard diet, for a period of 60 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •body mass index 28-39.9 kilograms per square meter
- •weigh less than 500 lbs
- •able to fast overnight (greater than 10 hours)
排除标准
- •tobacco user
- •diagnosed with type 1 or 2 diabetes
- •diagnosed with liver disease
- •adversity to fiber or protein supplements
- •allergic to any of the ingredients
- •taking a weight loss dietary supplement or adhering to a weight loss plan for the month prior to or during the study
- •consumption of alcohol within 24 hours of study visit
- •consumption of caffeine within 24 hours of study visit
- •strenuous exercise within 24 hours of study visit
- •self-reported active infection or illness
- •pregnant or lactating
研究组 & 干预措施
Active Nutrition program
Subjects in this arm will follow the Active Nutrition program for 60 days with study visits at 0 days, 30 days, and 60 days.
干预措施: meal replacements and supplements (Dietary Supplement)
Regular Diet
Subjects in this arm will follow their regular diet for 60 days with study visits at 0 days, 30 days, and 60 days.
结局指标
主要结局
Resting Heart Rate
时间窗: 60 days of assigned diet
Heart Rate will be determined in beats per minute using an automated blood pressure cuff following a 10 minute rest.
Perceived wellness
时间窗: 60 days of assigned diet
Perceived wellness will be self-reported using a 100 millimeter visual analog scale from 0 (very low) to 10 (extremely high) for self-esteem, energy level, motivation, irritability, focus, hunger, endurance, life satisfaction, physical appearance, and strength
Diastolic Blood Pressure
时间窗: 60 days of assigned diet
Diastolic blood pressure will be determined in millimeters mercury using an automated blood pressure cuff following a 10 minute rest.
Systolic Blood Pressure
时间窗: 60 days of assigned diet
Systolic blood pressure will be determined in millimeters mercury using an automated blood pressure cuff following a 10 minute rest.
Lipids
时间窗: 60 days of assigned diet
Blood lipids (cholesterol, high density lipids, low density lipids, triglycerides and very low density lipids) will be measured in mg/dL.
Insulin
时间窗: 60 days of assigned diet
Insulin will be measured from serum in micro-international units per milliliter.
Body Weight
时间窗: 60 days of assigned diet
Body weight will determined in kilograms using a digital scale.
Hip circumference
时间窗: 60 days of assigned diet
Hip circumference will be measured in centimeter.
Body Mass Index
时间窗: 60 days of assigned diet
body mass index will be calculated in kg per square meter from height and weight measurements.
Glucose
时间窗: 60 days of assigned diet
Glucose will be measured in whole blood using a glucometer in mg/dL.
Waist circumference
时间窗: 60 days of assigned diet
Waist circumference will be measured in centimeter.
Body composition mass
时间窗: 60 days of assigned diet
Body composition masses of fat, lean mass, visceral fat, and bone mineral in grams will be determined via Dual-energy x-ray absorptiometry.
Body composition percentages
时间窗: 60 days of assigned diet
body composition percentages of fat and lean mass will be determined via Dual-energy x-ray absorptiometry.
Lipids
时间窗: 0 days of assigned diet (baseline)
Blood lipids (cholesterol, high density lipids, low density lipids, triglycerides and very low density lipids) will be measured in milligram per deciliter (mg/dL).
Lipids
时间窗: 30 days of assigned diet
Blood lipids (cholesterol, high density lipids, low density lipids, triglycerides and very low density lipids) will be measured in mg/dL.
Glucose
时间窗: 0 days of assigned diet (baseline)
Glucose will be measured in whole blood using a glucometer in mg/dL.
Waist circumference
时间窗: 30 days of assigned diet
Waist circumference will be measured in centimeter.
Glucose
时间窗: 30 days of assigned diet
Glucose will be measured in whole blood using a glucometer in mg/dL.
Insulin
时间窗: 0 days of assigned diet (baseline)
Insulin will be measured from serum in micro-international units per milliliter.
Insulin
时间窗: 30 days of assigned diet
Insulin will be measured from serum in micro-international units per milliliter.
Body Weight
时间窗: 0 days of assigned diet (baseline)
Body weight will determined in kilograms using a digital scale.
Body Weight
时间窗: 30 days of assigned diet
Body weight will determined in kilograms using a digital scale.
Waist circumference
时间窗: 0 days of assigned diet (baseline)
Waist circumference will be measured in centimeter.
Hip circumference
时间窗: 0 days of assigned diet (baseline)
Hip circumference will be measured in centimeter.
Hip circumference
时间窗: 30 days of assigned diet
Hip circumference will be measured in centimeter.
Body Mass Index
时间窗: 0 days of assigned diet (baseline)
body mass index will be calculated in kg per square meter from height and weight measurements.
Body Mass Index
时间窗: 30 days of assigned diet
body mass index will be calculated in kg per square meter from height and weight measurements.
Body composition percentages
时间窗: 0 days of assigned diet (baseline)
body composition percentages of fat and lean mass will be determined via Dual-energy x-ray absorptiometry.
Body composition percentages
时间窗: 30 days of assigned diet
body composition percentages of fat and lean mass will be determined via Dual-energy x-ray absorptiometry.
Body composition mass
时间窗: 0 days of assigned diet (baseline)
Body composition masses of fat, lean mass, visceral fat, and bone mineral in grams will be determined via Dual-energy x-ray absorptiometry.
Body composition mass
时间窗: 30 days of assigned diet
Body composition masses of fat, lean mass, visceral fat, and bone mineral in grams will be determined via Dual-energy x-ray absorptiometry.
Resting Heart Rate
时间窗: 0 days of assigned diet (baseline)
Heart Rate will be determined in beats per minute using an automated blood pressure cuff following a 10 minute rest.
Resting Heart Rate
时间窗: 30 days of assigned diet
Heart Rate will be determined in beats per minute using an automated blood pressure cuff following a 10 minute rest.
Diastolic Blood Pressure
时间窗: 0 days of assigned diet (baseline)
Diastolic Blood Pressure will be determined in millimeters mercury using an automated blood pressure cuff following a 10 minute rest.
Diastolic Blood Pressure
时间窗: 30 days of assigned diet
Diastolic blood pressure will be determined in millimeters mercury using an automated blood pressure cuff following a 10 minute rest.
Systolic Blood Pressure
时间窗: 0 days of assigned diet (baseline)
Systolic blood pressure will be determined in millimeters mercury using an automated blood pressure cuff following a 10 minute rest.
Systolic Blood Pressure
时间窗: 30 days of assigned diet
Systolic blood pressure will be determined in millimeters mercury using an automated blood pressure cuff following a 10 minute rest.
Perceived wellness
时间窗: 0 days of assigned diet (baseline)
Perceived wellness will be self-reported using a 100 millimeter visual analog scale from 0 (very low) to 10 (extremely high) for self-esteem, energy level, motivation, irritability, focus, hunger, endurance, life satisfaction, physical appearance, and strength
Perceived wellness
时间窗: 30 days of assigned diet
Perceived wellness will be self-reported using a 100 millimeter visual analog scale from 0 (very low) to 10 (extremely high) for self-esteem, energy level, motivation, irritability, focus, hunger, endurance, life satisfaction, physical appearance, and strength
次要结局
未报告次要终点