Clinical trial NCT06249698: Active Nutrition Program on Weight Loss
Official title: Impact of Active Nutrition Program on Weight Loss and Associated Measures of Health in Overweight and Obese Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Keywords: Active Nutrition
Lead sponsor: University of Memphis
Sponsor class: OTHER
Collaborators: name: USANA Health Sciences
First posted: 2024-02-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental randomly assigned unblinded
Primary purpose: BASIC_SCIENCE

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lipids
timeFrame: 0 days of assigned diet (baseline)
measure: Lipids
timeFrame: 30 days of assigned diet
measure: Lipids
timeFrame: 60 days of assigned diet
measure: Glucose
timeFrame: 0 days of assigned diet (baseline)
measure: Glucose
timeFrame: 30 days of assigned diet
measure: Glucose
timeFrame: 60 days of assigned diet
measure: Insulin
timeFrame: 0 days of assigned diet (baseline)
measure: Insulin
timeFrame: 30 days of assigned diet
measure: Insulin
timeFrame: 60 days of assigned diet
measure: Body Weight
timeFrame: 0 days of assigned diet (baseline)
measure: Body Weight
timeFrame: 30 days of assigned diet
measure: Body Weight
timeFrame: 60 days of assigned diet
measure: Waist circumference
timeFrame: 0 days of assigned diet (baseline)
measure: Waist circumference
timeFrame: 30 days of assigned diet
measure: Waist circumference
timeFrame: 60 days of assigned diet
measure: Hip circumference
timeFrame: 0 days of assigned diet (baseline)
measure: Hip circumference
timeFrame: 30 days of assigned diet
measure: Hip circumference
timeFrame: 60 days of assigned diet
measure: Body Mass Index
timeFrame: 0 days of assigned diet (baseline)
measure: Body Mass Index
timeFrame: 30 days of assigned diet
measure: Body Mass Index
timeFrame: 60 days of assigned diet
measure: Body composition percentages
timeFrame: 0 days of assigned diet (baseline)
measure: Body composition percentages
timeFrame: 30 days of assigned diet
measure: Body composition percentages
timeFrame: 60 days of assigned diet
measure: Body composition mass
timeFrame: 0 days of assigned diet (baseline)
measure: Body composition mass
timeFrame: 30 days of assigned diet
measure: Body composition mass
timeFrame: 60 days of assigned diet
measure: Resting Heart Rate
timeFrame: 0 days of assigned diet (baseline)
measure: Resting Heart Rate
timeFrame: 30 days of assigned diet
measure: Resting Heart Rate
timeFrame: 60 days of assigned diet
measure: Diastolic Blood Pressure
timeFrame: 0 days of assigned diet (baseline)
measure: Diastolic Blood Pressure
timeFrame: 30 days of assigned diet
measure: Diastolic Blood Pressure
timeFrame: 60 days of assigned diet
measure: Systolic Blood Pressure
timeFrame: 0 days of assigned diet (baseline)
measure: Systolic Blood Pressure
timeFrame: 30 days of assigned diet
measure: Systolic Blood Pressure
timeFrame: 60 days of assigned diet
measure: Perceived wellness
timeFrame: 0 days of assigned diet (baseline)
measure: Perceived wellness
timeFrame: 30 days of assigned diet
measure: Perceived wellness
timeFrame: 60 days of assigned diet
Secondary outcomes:
Other outcomes:
measure: Digital images
timeFrame: 0 days of assigned diet (baseline)
measure: Digital images
timeFrame: 30 days of assigned diet
measure: Digital images
timeFrame: 60 days of assigned diet
Locations:
city: Memphis
country: United States
facility: Center for Nutraceutical and Dietary Supplement Reseach
state: Tennessee
Study officials:
affiliation: University of Memphis
name: Michelle Stockton, PhD
role: PRINCIPAL_INVESTIGATOR
References: