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ACTIVE NOT RECRUITING

NCT07227701

A Comparison of Satiety Effects Two Commercially Available Snack Bars

Sponsor: Indiana University

View on ClinicalTrials.gov

Summary

The researchers are investigating the satiety effects of two commercially available snack bars. Qualified participants are age 18-65 with a body mass index of 18.5 to 29.9 kilograms of body weight per meter squared in height who are in good metabolic health. Participants will engage in two study visits conducted at the Indiana University--Bloomington Innovation Center. Study visits are separated by a 1-14 day washout period. Prior to each study visit, participants are asked to engage in normal activity and to refrain from strenuous exercise. Furthermore, subjects are asked to consume a typical diet the day prior to the study visit with one caveat; they are to consume standard frozen dinners (evening meal) of their choosing between 7-8 PM and to remain fasted afterward except for water and non-caloric beverages until the study visit the following day. The amount of food provided for the evening meal is estimated using a standard calorie calculator based on the Mifflin-St. Jeor equation and an estimate of their activity level. Subjects are instructed to consume only as much of the provided food as needed to become comfortably full as they would ordinarily. Subjects record their diet for the day. Upon arrival at the Innovation Center between 8-8:40 AM, compliance with the prior day protocol is verified through interview, and the diet record is reviewed. Participants consume 300 kcal of snack bars and complete visual analogue scales to assess hunger, fullness, desire to eat, and satisfaction at fasting and at 30 minute intervals from the fasting measurement for 2 hours. Immediately after consuming the snack bars, subjects complete a sensory evaluation of the snack bars. Fifteen to thirty minutes after completion of the final visual analogue scale, subjects will be presented with an individual buffet which they consume ad libitum until comfortably full. A second study visit that mirrors the first but with different bars is conducted after the washout period (1-14 days).

Official title: A Comparison of Satiety Effects of High Protein Snack Bars and High Carbohydrate Snack Bars

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-02-27

Completion Date

2026-03-31

Last Updated

2026-03-27

Healthy Volunteers

Yes

Conditions

Satiety

Interventions

OTHER

High carbohydrate snack bar

A snack bar containing 26 grams of carbohydrate and 2 grams of protein.

OTHER

High protein snack bar

A snack bar containing 28 grams of protein and 2 grams of carbohydrate

Inclusion Criteria: * Persons 18 to 65 years of age, inclusive * BMI 18.5-29.9 kg/m2 inclusive * Subject understands the study procedures and signs forms documenting informed consent to participate in the study and is willing and able to complete study procedures. * Subject is judged by the Co-Investigator to be in general good health without diabetes, cardiovascular disease, or cancer that has not been in remission in the past 3 years on the basis of medical history and screening measurements. * Subject is willing and able to find their own transportation to the IU SPH metabolic kitchen for meal pickups and study visits. * Subject can comply with study food consumption and energy intake during each treatment condition and access to safe storage and preparation of the provided dinner. * Subject is willing to follow his/her usual physical activity throughout the study. Exclusion Criteria: * Subject is unwilling or unable to safely store, prepare (heat in a microwave oven), and consume the provided dinner meals and to control energy intake on the lead-in days. * Subject is unable to comply with the study timeline. * Because one of the dietary interventions contains eggs and whey, vegans and vegetarians who do not consume eggs or milk products are excluded. Lacto-ovo vegetarians are eligible to apply for participation. * Subjects reporting allergies to any ingredients listed on the ingredient lists of each snack bar are not eligible. It should be noted that eggs, tree and ground nuts, and dairy appear on the ingredient lists and are examples (non-exhaustive) of common allergens that might disqualify a participant. The ingredient lists for each product is provided as an attachment. * Subject is using medications known to affect appetite, blood lipids, body composition, body weight, or food intake such as statins and GLP-1 receptor agonists. * Subject has a previous history of eating or gastrointestinal disorders such as Inflammatory Bowel Disease, Irritable Bowel Syndrome, Celiac Disease, gluten intolerance, stomach ulcers etc. * Subject has had any form of bariatric surgery. * Subject is currently known to be pregnant or is lactating. * Subject has diagnosed metabolic diseases such as diabetes, cardiovascular disease such as hypertriglyceridemia, untreated hypercholesterolemia, or hypertension, that limits their intake of certain foods that may impact their health, or cancer within the last 3 years.

Locations (1)

Indiana University--Bloomington School of Public Health

Bloomington, Indiana, United States