Active Nutrition Program on Weight Loss

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06249698
• Other study ID #: PRO-FY2022-181
• Status: Completed
• Phase: N/A
• Start date: February 22, 2022
• Est. completion date: September 7, 2023

Study information

• Verified date: January 2024
• Source: University of Memphis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 7, 2023
• Est. primary completion date: August 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	Center for Nutraceutical and Dietary Supplement Reseach	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
University of Memphis	USANA Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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
Other	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
Primary	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)
Primary	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
Primary	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
Primary	Glucose	Glucose will be measured in whole blood using a glucometer in mg/dL.	0 days of assigned diet (baseline)
Primary	Glucose	Glucose will be measured in whole blood using a glucometer in mg/dL.	30 days of assigned diet
Primary	Glucose	Glucose will be measured in whole blood using a glucometer in mg/dL.	60 days of assigned diet
Primary	Insulin	Insulin will be measured from serum in micro-international units per milliliter.	0 days of assigned diet (baseline)
Primary	Insulin	Insulin will be measured from serum in micro-international units per milliliter.	30 days of assigned diet
Primary	Insulin	Insulin will be measured from serum in micro-international units per milliliter.	60 days of assigned diet
Primary	Body Weight	Body weight will determined in kilograms using a digital scale.	0 days of assigned diet (baseline)
Primary	Body Weight	Body weight will determined in kilograms using a digital scale.	30 days of assigned diet
Primary	Body Weight	Body weight will determined in kilograms using a digital scale.	60 days of assigned diet
Primary	Waist circumference	Waist circumference will be measured in centimeter.	0 days of assigned diet (baseline)
Primary	Waist circumference	Waist circumference will be measured in centimeter.	30 days of assigned diet
Primary	Waist circumference	Waist circumference will be measured in centimeter.	60 days of assigned diet
Primary	Hip circumference	Hip circumference will be measured in centimeter.	0 days of assigned diet (baseline)
Primary	Hip circumference	Hip circumference will be measured in centimeter.	30 days of assigned diet
Primary	Hip circumference	Hip circumference will be measured in centimeter.	60 days of assigned diet
Primary	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)
Primary	Body Mass Index	body mass index will be calculated in kg per square meter from height and weight measurements.	30 days of assigned diet
Primary	Body Mass Index	body mass index will be calculated in kg per square meter from height and weight measurements.	60 days of assigned diet
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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