Weight Loss
Conditions
Keywords
Active Nutrition
Brief summary
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).
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTmeal replacements and supplements
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
Sponsors
USANA Health Sciences
University of Memphis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Experimental randomly assigned unblinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* body mass index 28-39.9 kilograms per square meter * weigh less than 500 lbs * able to fast overnight (greater than 10 hours)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived wellness | 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 |
| Body Mass Index | 0 days of assigned diet (baseline) | body mass index will be calculated in kg per square meter from height and weight measurements. |
| Body composition percentages | 0 days of assigned diet (baseline) | body composition percentages of fat and lean mass will be determined via Dual-energy x-ray absorptiometry. |
| Lipids | 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). |
| Glucose | 0 days of assigned diet (baseline) | Glucose will be measured in whole blood using a glucometer in mg/dL. |
| Insulin | 0 days of assigned diet (baseline) | Insulin will be measured from serum in micro-international units per milliliter. |
| Body Weight | 0 days of assigned diet (baseline) | Body weight will determined in kilograms using a digital scale. |
| Waist circumference | 0 days of assigned diet (baseline) | Waist circumference will be measured in centimeter. |
| Hip circumference | 0 days of assigned diet (baseline) | Hip circumference will be measured in centimeter. |
| Body composition mass | 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. |
| Resting Heart Rate | 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. |
| Diastolic Blood Pressure | 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. |
| Systolic Blood Pressure | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Digital images | 0 days of assigned diet (baseline) | Digital images, for subjects consenting to photographing, will be collected from the subject's neck to knees from front, side, and back wearing form fitting clothing. |
Countries
United States
Outcome results
None listed