NCT07227701

Brief 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).

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 27, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 13, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

August 25, 2025

Last Update Submit

March 24, 2026

Conditions

Keywords

SatietyHungerfood intakesatisfactiondesire to eatsnack bars

Outcome Measures

Primary Outcomes (5)

  • Food Intake

    An individual buffet is provided in which participants consume as much food as they like until comfortably full. Buffet items include hamburgers, grilled chicken, buns, tomatoes, cheese, condiments (mayonnaise, mustard and ketchup), potato chips, mixed nuts, cookes, and a fruit tray of cantaloupe, watermelon, blueberries, strawberries, and pineapple with whipped cream offered as a condiment. Food are weighed before and after consumption of the buffet and macronutrient content is assessed from the nutrient facts label or from the USDA FoodData Central database.

    2:15-2:30 minutes postprandial

  • Hunger

    The study will assess hunger using 1-100 point visual analogue scales.

    Fasting and every 30 minutes for 2 hours (5 time points)

  • Fullness

    The study will assess fullness using 1-100 point visual analogue scales.

    Fasting and postprandial every 30 minutes for 2 hours (5 time points) at visits 1 and 2.

  • Desire to eat

    The study will assess subjective desire to eat using a 1-100 point visual analogue scale.

    This question will be presented at fasting and postprandially every 30 minute for 2 hours (5 time points) at visit 1 and visit 2.

  • Satisfaction with the meal

    Satisfaction with the meal will be assessed using a 1-100 point visual analogue scale.

    Presented at fasting, and every 30 minutes postprandially for 2 hours during visit 1 and 2

Other Outcomes (7)

  • Taste

    The sensory evaluation is completed after consumption of the snack bars on visit 1 and visit 2.

  • Sweetness

    The sensory evaluation is completed after the subjects consume the snack bars on visits 1 and 2.

  • Saltiness

    The sensory evaluation is completed after the subjects consume the bars on visits 1 and 2.

  • +4 more other outcomes

Study Arms (2)

Two high carbohydrate snack bars conferring 150 Kcal each for a total of 300 Kcal.

ACTIVE COMPARATOR

The snack bars are presented with ad libitum bottled water.

Other: High carbohydrate snack bar

Two high protein snack bars conferring 150 Kcal each for a total of 300 Kcal.

EXPERIMENTAL

This arm involves a snack bar with a different nutrient profile than the comparator.

Other: High protein snack bar

Interventions

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

Two high carbohydrate snack bars conferring 150 Kcal each for a total of 300 Kcal.

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

Two high protein snack bars conferring 150 Kcal each for a total of 300 Kcal.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University--Bloomington School of Public Health

Bloomington, Indiana, 47405, United States

Location

Related Publications (2)

  • Senn SS. Cross-over Trials in Clinical Research. 2nd edition. Chichester, Eng. ; New York: Wiley; 2002.

    BACKGROUND
  • Gadbury GL, Coffey CS, Allison DB. Modern statistical methods for handling missing repeated measurements in obesity trial data: beyond LOCF. Obes Rev 2003;4:175-84. https://doi.org/10.1046/j.1467-789X.2003.00109.x.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Acute, single blinded, randomized crossover design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 25, 2025

First Posted

November 13, 2025

Study Start

February 27, 2025

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

There is no need to share individual participant data.

Locations