Clinical trial NCT04740112: Beta-glucan, Product Claims and Satiety
Official title: Effects of Beta-glucan and Product Claims for Breakfast Bars on Appetite Response and Consumer Preference: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: General Mills
Sponsor class: INDUSTRY
First posted: 2021-02-05
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a digital clinical trial to investigate satiety and consumer preference in responses to three test breakfast bars with varying level of dietary fiber, beta-glucan, and product packages (with or without product claims) in healthy adults.


Eligibility criteria: Inclusion Criteria:

* Healthy adults 18-70 years.
* Habitual snack bar consumers (consume bars at least 3 times a week).
* Body mass index 20-29.9 kg/m² (based on self-reported weight and height).
* Understand the study procedures.
* Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
* Willing to follow study procedures on test days.
* Willing to abstain from strenuous exercise, consuming alcoholic drinks 24 hours before the test day.
* Willing to provide informed consent to participate in the study.
* Willing to maintain confidentiality of the study and test products.

Exclusion Criteria:

* Pregnant or lactating women, or women who are planning to become pregnant during the study
* Known food allergies, sensitivity, or intolerance to any food or food ingredients
* Participating in another clinical trial for food, investigational drug, nutritional supplement, or lifestyle modification
* Taking medications that affect appetite, metabolism, or blood pressure
* Taking supplements with dietary fiber
* Presence of acute diseases or infection
* Presence or history of chronic diseases
* Diagnosed with eating disorders
* Restraint eaters
* Lost or gained 5 pounds or more in the past 3 months

Primary outcomes:
measure: Hunger
timeFrame: 30 minutes after consumption
measure: Hunger
timeFrame: 60 minutes after consumption
measure: Hunger
timeFrame: 90 minutes after consumption
measure: Hunger
timeFrame: 120 minutes after consumption
measure: Hunger
timeFrame: 180 minutes after consumption
measure: Fullness
timeFrame: 30 minutes after consumption
measure: Fullness
timeFrame: 60 minutes after consumption
measure: Fullness
timeFrame: 90 minutes after consumption
measure: Fullness
timeFrame: 120 minutes after consumption
measure: Fullness
timeFrame: 180 minutes after consumption
measure: Desire to eat
timeFrame: 30 minutes after test meal consumption
measure: Desire to eat
timeFrame: 60 minutes after test meal consumption
measure: Desire to eat
timeFrame: 90 minutes after test meal consumption
measure: Desire to eat
timeFrame: 120 minutes after test meal consumption
measure: Desire to eat
timeFrame: 180 minutes after test meal consumption
measure: Prospective consumption
timeFrame: 30 minutes after test meal consumption
measure: Prospective consumption
timeFrame: 60 minutes after test meal consumption
measure: Prospective consumption
timeFrame: 90 minutes after test meal consumption
measure: Prospective consumption
timeFrame: 120 minutes after test meal consumption
measure: Prospective consumption
timeFrame: 180 minutes after test meal consumption
Secondary outcomes:
measure: Flavor rating
timeFrame: 30 minutes after test meal consumption
measure: Sweetness rating
timeFrame: 30 minutes after test meal consumption
measure: Texture rating
timeFrame: 30 minutes after test meal consumption
measure: Overall product liking
timeFrame: 30 minutes after test meal consumption
measure: Purchase intent
timeFrame: 180 minutes after test meal consumption
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: No physical visit to a research facility is required.
state: Minnesota
Study officials:
References: