Active Nutrition Program on Weight Loss

January 31, 2024 updated by: University of Memphis

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lipids
Time Frame: 0 days of assigned diet (baseline)
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
Time Frame: 30 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.
30 days of assigned diet
Lipids
Time Frame: 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.
60 days of assigned diet
Glucose
Time Frame: 0 days of assigned diet (baseline)
Glucose will be measured in whole blood using a glucometer in mg/dL.
0 days of assigned diet (baseline)
Glucose
Time Frame: 30 days of assigned diet
Glucose will be measured in whole blood using a glucometer in mg/dL.
30 days of assigned diet
Glucose
Time Frame: 60 days of assigned diet
Glucose will be measured in whole blood using a glucometer in mg/dL.
60 days of assigned diet
Insulin
Time Frame: 0 days of assigned diet (baseline)
Insulin will be measured from serum in micro-international units per milliliter.
0 days of assigned diet (baseline)
Insulin
Time Frame: 30 days of assigned diet
Insulin will be measured from serum in micro-international units per milliliter.
30 days of assigned diet
Insulin
Time Frame: 60 days of assigned diet
Insulin will be measured from serum in micro-international units per milliliter.
60 days of assigned diet
Body Weight
Time Frame: 0 days of assigned diet (baseline)
Body weight will determined in kilograms using a digital scale.
0 days of assigned diet (baseline)
Body Weight
Time Frame: 30 days of assigned diet
Body weight will determined in kilograms using a digital scale.
30 days of assigned diet
Body Weight
Time Frame: 60 days of assigned diet
Body weight will determined in kilograms using a digital scale.
60 days of assigned diet
Waist circumference
Time Frame: 0 days of assigned diet (baseline)
Waist circumference will be measured in centimeter.
0 days of assigned diet (baseline)
Waist circumference
Time Frame: 30 days of assigned diet
Waist circumference will be measured in centimeter.
30 days of assigned diet
Waist circumference
Time Frame: 60 days of assigned diet
Waist circumference will be measured in centimeter.
60 days of assigned diet
Hip circumference
Time Frame: 0 days of assigned diet (baseline)
Hip circumference will be measured in centimeter.
0 days of assigned diet (baseline)
Hip circumference
Time Frame: 30 days of assigned diet
Hip circumference will be measured in centimeter.
30 days of assigned diet
Hip circumference
Time Frame: 60 days of assigned diet
Hip circumference will be measured in centimeter.
60 days of assigned diet
Body Mass Index
Time Frame: 0 days of assigned diet (baseline)
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
Time Frame: 30 days of assigned diet
body mass index will be calculated in kg per square meter from height and weight measurements.
30 days of assigned diet
Body Mass Index
Time Frame: 60 days of assigned diet
body mass index will be calculated in kg per square meter from height and weight measurements.
60 days of assigned diet
Body composition percentages
Time Frame: 0 days of assigned diet (baseline)
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
Time Frame: 30 days of assigned diet
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
Time Frame: 60 days of assigned diet
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
Time Frame: 0 days of assigned diet (baseline)
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
Time Frame: 30 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.
30 days of assigned diet
Body composition mass
Time Frame: 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.
60 days of assigned diet
Resting Heart Rate
Time Frame: 0 days of assigned diet (baseline)
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
Time Frame: 30 days of assigned diet
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
Time Frame: 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.
60 days of assigned diet
Diastolic Blood Pressure
Time Frame: 0 days of assigned diet (baseline)
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
Time Frame: 30 days of assigned diet
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
Time Frame: 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.
60 days of assigned diet
Systolic Blood Pressure
Time Frame: 0 days of assigned diet (baseline)
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
Time Frame: 30 days of assigned diet
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
Time Frame: 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.
60 days of assigned diet
Perceived wellness
Time Frame: 0 days of assigned diet (baseline)
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
Time Frame: 30 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
30 days of assigned diet
Perceived wellness
Time Frame: 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
60 days of assigned diet

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Digital images
Time Frame: 0 days of assigned diet (baseline)
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
Time Frame: 30 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
Time Frame: 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.
60 days of assigned diet

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Memphis

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
USANA Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michelle Stockton, PhD, University of Memphis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 19, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 7, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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