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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
60
Consumed daily: 2 Nutrimeal Active meal replacement shake, 1 electrolyte replacement drink, 3 metabolism + supplements, 1 whole food meal, and whole food snacks consisting of fruits and vegetables. 1200-1600 calories per day
Center for Nutraceutical and Dietary Supplement Reseach
Memphis, Tennessee, United States
Lipids
Blood lipids (cholesterol, high density lipids, low density lipids, triglycerides and very low density lipids) will be measured in milligram per deciliter (mg/dL).
Time frame: 0 days of assigned diet (baseline)
Lipids
Blood lipids (cholesterol, high density lipids, low density lipids, triglycerides and very low density lipids) will be measured in mg/dL.
Time frame: 30 days of assigned diet
Lipids
Blood lipids (cholesterol, high density lipids, low density lipids, triglycerides and very low density lipids) will be measured in mg/dL.
Time frame: 60 days of assigned diet
Glucose
Glucose will be measured in whole blood using a glucometer in mg/dL.
Time frame: 0 days of assigned diet (baseline)
Glucose
Glucose will be measured in whole blood using a glucometer in mg/dL.
Time frame: 30 days of assigned diet
Glucose
Glucose will be measured in whole blood using a glucometer in mg/dL.
Time frame: 60 days of assigned diet
Insulin
Insulin will be measured from serum in micro-international units per milliliter.
Time frame: 0 days of assigned diet (baseline)
Insulin
Insulin will be measured from serum in micro-international units per milliliter.
Time frame: 30 days of assigned diet
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Insulin
Insulin will be measured from serum in micro-international units per milliliter.
Time frame: 60 days of assigned diet
Body Weight
Body weight will determined in kilograms using a digital scale.
Time frame: 0 days of assigned diet (baseline)
Body Weight
Body weight will determined in kilograms using a digital scale.
Time frame: 30 days of assigned diet
Body Weight
Body weight will determined in kilograms using a digital scale.
Time frame: 60 days of assigned diet
Waist circumference
Waist circumference will be measured in centimeter.
Time frame: 0 days of assigned diet (baseline)
Waist circumference
Waist circumference will be measured in centimeter.
Time frame: 30 days of assigned diet
Waist circumference
Waist circumference will be measured in centimeter.
Time frame: 60 days of assigned diet
Hip circumference
Hip circumference will be measured in centimeter.
Time frame: 0 days of assigned diet (baseline)
Hip circumference
Hip circumference will be measured in centimeter.
Time frame: 30 days of assigned diet
Hip circumference
Hip circumference will be measured in centimeter.
Time frame: 60 days of assigned diet
Body Mass Index
body mass index will be calculated in kg per square meter from height and weight measurements.
Time frame: 0 days of assigned diet (baseline)
Body Mass Index
body mass index will be calculated in kg per square meter from height and weight measurements.
Time frame: 30 days of assigned diet
Body Mass Index
body mass index will be calculated in kg per square meter from height and weight measurements.
Time frame: 60 days of assigned diet
Body composition percentages
body composition percentages of fat and lean mass will be determined via Dual-energy x-ray absorptiometry.
Time frame: 0 days of assigned diet (baseline)
Body composition percentages
body composition percentages of fat and lean mass will be determined via Dual-energy x-ray absorptiometry.
Time frame: 30 days of assigned diet
Body composition percentages
body composition percentages of fat and lean mass will be determined via Dual-energy x-ray absorptiometry.
Time frame: 60 days of assigned diet
Body composition mass
Body composition masses of fat, lean mass, visceral fat, and bone mineral in grams will be determined via Dual-energy x-ray absorptiometry.
Time frame: 0 days of assigned diet (baseline)
Body composition mass
Body composition masses of fat, lean mass, visceral fat, and bone mineral in grams will be determined via Dual-energy x-ray absorptiometry.
Time frame: 30 days of assigned diet
Body composition mass
Body composition masses of fat, lean mass, visceral fat, and bone mineral in grams will be determined via Dual-energy x-ray absorptiometry.
Time frame: 60 days of assigned diet
Resting Heart Rate
Heart Rate will be determined in beats per minute using an automated blood pressure cuff following a 10 minute rest.
Time frame: 0 days of assigned diet (baseline)
Resting Heart Rate
Heart Rate will be determined in beats per minute using an automated blood pressure cuff following a 10 minute rest.
Time frame: 30 days of assigned diet
Resting Heart Rate
Heart Rate will be determined in beats per minute using an automated blood pressure cuff following a 10 minute rest.
Time frame: 60 days of assigned diet
Diastolic Blood Pressure
Diastolic Blood Pressure will be determined in millimeters mercury using an automated blood pressure cuff following a 10 minute rest.
Time frame: 0 days of assigned diet (baseline)
Diastolic Blood Pressure
Diastolic blood pressure will be determined in millimeters mercury using an automated blood pressure cuff following a 10 minute rest.
Time frame: 30 days of assigned diet
Diastolic Blood Pressure
Diastolic blood pressure will be determined in millimeters mercury using an automated blood pressure cuff following a 10 minute rest.
Time frame: 60 days of assigned diet
Systolic Blood Pressure
Systolic blood pressure will be determined in millimeters mercury using an automated blood pressure cuff following a 10 minute rest.
Time frame: 0 days of assigned diet (baseline)
Systolic Blood Pressure
Systolic blood pressure will be determined in millimeters mercury using an automated blood pressure cuff following a 10 minute rest.
Time frame: 30 days of assigned diet
Systolic Blood Pressure
Systolic blood pressure will be determined in millimeters mercury using an automated blood pressure cuff following a 10 minute rest.
Time frame: 60 days of assigned diet
Perceived wellness
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
Time frame: 0 days of assigned diet (baseline)
Perceived wellness
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
Time frame: 30 days of assigned diet
Perceived wellness
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
Time frame: 60 days of assigned diet