NCT06249698

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 8, 2024

Completed
Last Updated

February 8, 2024

Status Verified

January 1, 2024

Enrollment Period

1.5 years

First QC Date

January 31, 2024

Last Update Submit

January 31, 2024

Conditions

Weight Loss

Keywords

Active Nutrition

Outcome Measures

Primary Outcomes (39)

  • 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 Outcomes (3)

  • Digital images

    0 days of assigned diet (baseline)

  • Digital images

    30 days of assigned diet

  • Digital images

    60 days of assigned diet

Study Arms (2)

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.

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.

Interventions

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

Active Nutrition program

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • body mass index 28-39.9 kilograms per square meter
  • weigh less than 500 lbs
  • able to fast overnight (greater than 10 hours)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Nutraceutical and Dietary Supplement Reseach

Memphis, Tennessee, 38152, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michelle Stockton, PhD

    University of Memphis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Experimental randomly assigned unblinded
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2024

First Posted

February 8, 2024

Study Start

February 22, 2022

Primary Completion

August 19, 2023

Study Completion

September 7, 2023

Last Updated

February 8, 2024

Record last verified: 2024-01

Locations

US(1)