Active Nutrition Program on Weight Loss

Impact of Active Nutrition Program on Weight Loss and Associated Measures of Health in Overweight and Obese Men and Women

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).

Study Overview

• Status: Completed
• Conditions: Weight Loss
• Intervention / Treatment: Dietary supplement: meal replacements and supplements

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38152
      • Center for Nutraceutical and Dietary Supplement Reseach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: meal 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
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Memphis
• Collaborators: USANA Health Sciences
• Investigators: Principal Investigator: Michelle Stockton, PhD, University of Memphis

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2022
• Primary Completion (Actual): August 19, 2023
• Study Completion (Actual): September 7, 2023

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Active Nutrition
• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: PRO-FY2022-181

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No