Weight LossNCT06249698
Active Nutrition Program on Weight Loss
A study testing meal replacements and supplements in people with Weight Loss, run by University of Memphis at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- meal replacements and supplements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2022to 7 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- body mass index 28-39.9 kilograms per square meter
- weigh less than 500 lbs
- able to fast overnight (greater than 10 hours)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Nutraceutical and Dietary Supplement Reseach
Memphis, Tennessee, 38152
About this study
Official title: 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).
Read the 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.
- Conditions
- Weight Loss
- Being tested
- meal replacements and supplements
- Keywords
- Active Nutrition
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meal replacements and supplementsDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Active Nutrition program | Experimental | Subjects in this arm will follow the Active Nutrition program for 60 days with study visits at 0 days, 30 days, and 60 days. Receives: Dietary Supplement: meal replacements and supplements |
| Regular Diet | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 60 days of assigned diet
Glucose
Glucose will be measured in whole blood using a glucometer in mg/dL.
Measured: 0 days of assigned diet (baseline)
Glucose
Glucose will be measured in whole blood using a glucometer in mg/dL.
Measured: 30 days of assigned diet
Glucose
Glucose will be measured in whole blood using a glucometer in mg/dL.
Measured: 60 days of assigned diet
Insulin
Insulin will be measured from serum in micro-international units per milliliter.
Measured: 0 days of assigned diet (baseline)
Insulin
Insulin will be measured from serum in micro-international units per milliliter.
Measured: 30 days of assigned diet
Insulin
Insulin will be measured from serum in micro-international units per milliliter.
Measured: 60 days of assigned diet
Body Weight
Body weight will determined in kilograms using a digital scale.
Measured: 0 days of assigned diet (baseline)
Body Weight
Body weight will determined in kilograms using a digital scale.
Measured: 30 days of assigned diet
Body Weight
Body weight will determined in kilograms using a digital scale.
Measured: 60 days of assigned diet
Waist circumference
Waist circumference will be measured in centimeter.
Measured: 0 days of assigned diet (baseline)
Waist circumference
Waist circumference will be measured in centimeter.
Measured: 30 days of assigned diet
Waist circumference
Waist circumference will be measured in centimeter.
Measured: 60 days of assigned diet
Hip circumference
Hip circumference will be measured in centimeter.
Measured: 0 days of assigned diet (baseline)
Hip circumference
Hip circumference will be measured in centimeter.
Measured: 30 days of assigned diet
Hip circumference
Hip circumference will be measured in centimeter.
Measured: 60 days of assigned diet
Body Mass Index
body mass index will be calculated in kg per square meter from height and weight measurements.
Measured: 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.
Measured: 30 days of assigned diet
Body Mass Index
body mass index will be calculated in kg per square meter from height and weight measurements.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 60 days of assigned diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start22 Feb 2022
- Primary completion19 Aug 2023
- Study completion7 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental randomly assigned unblinded
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Memphis
- Sponsor type
- University, hospital or other
- Collaborators
- USANA Health Sciences
- Responsible party
- Sponsor
- Investigators
- Michelle Stockton, PhD, Principal investigator, University of Memphis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249698
- Sponsor's protocol ID
- PRO-FY2022-181
- Status last verified
- Jan 2024
- First submitted
- 31 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Active Nutrition Program on Weight Loss and Associated Measures of Health in Overweight and Obese Men and Women
- ClinicalTrials.gov ID
- NCT06249698
- Acronym / sponsor ID
- PRO-FY2022-181
- Conditions
- Weight Loss
- Keywords
- Active Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MemphisUniversity, hospital or other
- Collaborators
- USANA Health Sciences
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 19 Aug 2023 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental randomly assigned unblinded
| Arm | Type | Receives |
|---|---|---|
| Active Nutrition program | Experimental | Dietary Supplement: meal replacements and supplementsSubjects in this arm will follow the Active Nutrition program for 60 days with study visits at 0 days, 30 days, and 60 days. |
| Regular Diet | No intervention | –Subjects in this arm will follow their regular diet for 60 days with study visits at 0 days, 30 days, and 60 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- body mass index 28-39.9 kilograms per square meter
- weigh less than 500 lbs
- able to fast overnight (greater than 10 hours)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| meal replacements and supplementsConsumed 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 | Dietary supplement | Active Nutrition program |
Primary outcome
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).
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.
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.
Glucose
Time frame: 0 days of assigned diet (baseline)
Glucose will be measured in whole blood using a glucometer in mg/dL.
Glucose
Time frame: 30 days of assigned diet
Glucose will be measured in whole blood using a glucometer in mg/dL.
Glucose
Time frame: 60 days of assigned diet
Glucose will be measured in whole blood using a glucometer in mg/dL.
Insulin
Time frame: 0 days of assigned diet (baseline)
Insulin will be measured from serum in micro-international units per milliliter.
Insulin
Time frame: 30 days of assigned diet
Insulin will be measured from serum in micro-international units per milliliter.
Insulin
Time frame: 60 days of assigned diet
Insulin will be measured from serum in micro-international units per milliliter.
Body Weight
Time frame: 0 days of assigned diet (baseline)
Body weight will determined in kilograms using a digital scale.
Body Weight
Time frame: 30 days of assigned diet
Body weight will determined in kilograms using a digital scale.
Body Weight
Time frame: 60 days of assigned diet
Body weight will determined in kilograms using a digital scale.
Waist circumference
Time frame: 0 days of assigned diet (baseline)
Waist circumference will be measured in centimeter.
Waist circumference
Time frame: 30 days of assigned diet
Waist circumference will be measured in centimeter.
Waist circumference
Time frame: 60 days of assigned diet
Waist circumference will be measured in centimeter.
Hip circumference
Time frame: 0 days of assigned diet (baseline)
Hip circumference will be measured in centimeter.
Hip circumference
Time frame: 30 days of assigned diet
Hip circumference will be measured in centimeter.
Hip circumference
Time frame: 60 days of assigned diet
Hip circumference will be measured in centimeter.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
Related trials for Weight Loss
Not yet recruitingPhase 3
SYNCHRONIZE®-START- A Study to Test Whether Survodutide Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
Obesity
Not yet recruitingPhase 1/2
Investigating the Effects of 24 Hour LEAP2 Infusion in Individuals With Overweight and Obesity
Obesity & Overweight
Recruiting
OverStitch NXT Endoscopic Suture System
Weight Loss
Recruiting
Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365')
Weight Loss
RecruitingPhase 2
Study to Assess the Effect and Safety of ALV-100 on Maintenance of Weight Loss
Overweight , Obesity, Adults
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Stockton, PhD principal investigator
University of Memphis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing meal replacements and supplements in people with Weight Loss, run by University of Memphis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipids (time frame: 0 days of assigned diet (baseline)). The study lists 39 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.