Active Nutrition Program on Weight Loss

Not Applicable

Completed

• Conditions: Weight Loss
• Interventions: Dietary Supplement: meal replacements and supplements

• Registration Number: NCT06249698
• Lead Sponsor: University of Memphis

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.

Study Timeline

• Study Start: 2022-02-22
• Primary Completion: 2023-08-19
• Study Completion: 2023-09-07
• Status Verified: 2024-01
• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-01-31
• Last Update Submitted: 2024-01-31
• Study First Posted: 2024-02-08
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Nutrition program	meal replacements and supplements	Subjects in this arm will follow the Active Nutrition program for 60 days with study visits at 0 days, 30 days, and 60 days.

Primary Outcome Measures

Name	Time	Method
Body composition mass	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.
Lipids	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	60 days of assigned diet	Insulin will be measured from serum in micro-international units per milliliter.
Body Weight	60 days of assigned diet	Body weight will determined in kilograms using a digital scale.
Hip circumference	60 days of assigned diet	Hip circumference will be measured in centimeter.
Body Mass Index	60 days of assigned diet	body mass index will be calculated in kg per square meter from height and weight measurements.
Body composition percentages	60 days of assigned diet	body composition percentages of fat and lean mass will be determined via Dual-energy x-ray absorptiometry.
Resting Heart Rate	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.
Diastolic Blood Pressure	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	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.
Perceived wellness	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
Glucose	60 days of assigned diet	Glucose will be measured in whole blood using a glucometer in mg/dL.
Waist circumference	60 days of assigned diet	Waist circumference will be measured in centimeter.

Trial Locations

Locations (1)

Center for Nutraceutical and Dietary Supplement Reseach; 🇺🇸 Memphis, Tennessee, United States