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| Name | Class |
|---|---|
| USANA Health Sciences | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Nutrition program | Experimental | Subjects in this arm will follow the Active Nutrition program for 60 days with study visits at 0 days, 30 days, and 60 days. |
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| Regular Diet | No Intervention | Subjects in this arm will follow their regular diet for 60 days with study visits at 0 days, 30 days, and 60 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| meal replacements and supplements | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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. | 60 days of assigned diet |
| Glucose | Glucose will be measured in whole blood using a glucometer in mg/dL. | 0 days of assigned diet (baseline) |
| Glucose | Glucose will be measured in whole blood using a glucometer in mg/dL. | 30 days of assigned diet |
| Glucose | Glucose will be measured in whole blood using a glucometer in mg/dL. | 60 days of assigned diet |
| Insulin | Insulin will be measured from serum in micro-international units per milliliter. | 0 days of assigned diet (baseline) |
| Insulin |
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| Measure | Description | Time Frame |
|---|---|---|
| Digital images | 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. | 0 days of assigned diet (baseline) |
| Digital images |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Stockton, PhD | University of Memphis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Nutraceutical and Dietary Supplement Reseach | Memphis | Tennessee | 38152 | United States |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Experimental randomly assigned unblinded
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Insulin will be measured from serum in micro-international units per milliliter. |
| 30 days of assigned diet |
| Insulin | Insulin will be measured from serum in micro-international units per milliliter. | 60 days of assigned diet |
| Body Weight | Body weight will determined in kilograms using a digital scale. | 0 days of assigned diet (baseline) |
| Body Weight | Body weight will determined in kilograms using a digital scale. | 30 days of assigned diet |
| Body Weight | Body weight will determined in kilograms using a digital scale. | 60 days of assigned diet |
| Waist circumference | Waist circumference will be measured in centimeter. | 0 days of assigned diet (baseline) |
| Waist circumference | Waist circumference will be measured in centimeter. | 30 days of assigned diet |
| Waist circumference | Waist circumference will be measured in centimeter. | 60 days of assigned diet |
| Hip circumference | Hip circumference will be measured in centimeter. | 0 days of assigned diet (baseline) |
| Hip circumference | Hip circumference will be measured in centimeter. | 30 days of assigned diet |
| Hip circumference | Hip circumference will be measured in centimeter. | 60 days of assigned diet |
| Body Mass Index | body mass index will be calculated in kg per square meter from height and weight measurements. | 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. | 30 days of assigned diet |
| Body Mass Index | body mass index will be calculated in kg per square meter from height and weight measurements. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 60 days of assigned diet |
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.
| 30 days of assigned diet |
| Digital images | 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. | 60 days of assigned diet |