Active Nutrition Program on Weight Loss

NCT ID: NCT06249698

Last Updated: 2024-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-22

Study Completion Date

2023-09-07

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Experimental randomly assigned unblinded
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

meal replacements and supplements

Intervention Type 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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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USANA Health Sciences

INDUSTRY

Sponsor Role collaborator

University of Memphis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle Stockton, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Memphis

Locations

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Center for Nutraceutical and Dietary Supplement Reseach

Memphis, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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PRO-FY2022-181

Identifier Type: -

Identifier Source: org_study_id

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