Beta-glucan, Product Claims and Satiety

Healthy Clinical Trial

Official title:

Effects of Beta-glucan and Product Claims for Breakfast Bars on Appetite Response and Consumer Preference: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04740112
• Other study ID #: 2021/01/7
• Status: Completed
• Phase: N/A
• Start date: January 28, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: March 2024
• Source: General Mills
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 30, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Foods with beta-glucan from oats and barley
Breakfast bars made with varying levels of total dietary fiber and beta-glucan, with or without claims on package image

Locations

Country	Name	City	State
United States	No physical visit to a research facility is required.	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
General Mills

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hunger	Hunger as measured by visual analog scales in mm using appetite questionnaires	30 minutes after consumption
Primary	Hunger	Hunger as measured by visual analog scales in mm using appetite questionnaires	60 minutes after consumption
Primary	Hunger	Hunger as measured by visual analog scales in mm using appetite questionnaires	90 minutes after consumption
Primary	Hunger	Hunger as measured by visual analog scales in mm using appetite questionnaires	120 minutes after consumption
Primary	Hunger	Hunger as measured by visual analog scales in mm using appetite questionnaires	180 minutes after consumption
Primary	Fullness	Fullness as measured by visual analog scales in mm using appetite questionnaires	30 minutes after consumption
Primary	Fullness	Fullness as measured by visual analog scales in mm using appetite questionnaires	60 minutes after consumption
Primary	Fullness	Fullness as measured by visual analog scales in mm using appetite questionnaires	90 minutes after consumption
Primary	Fullness	Fullness as measured by visual analog scales in mm using appetite questionnaires	120 minutes after consumption
Primary	Fullness	Fullness as measured by visual analog scales in mm using appetite questionnaires	180 minutes after consumption
Primary	Desire to eat	Desire to eat as measured by visual analog scales in mm using appetite questionnaires	30 minutes after test meal consumption
Primary	Desire to eat	Desire to eat as measured by visual analog scales in mm using appetite questionnaires	60 minutes after test meal consumption
Primary	Desire to eat	Desire to eat as measured by visual analog scales in mm using appetite questionnaires	90 minutes after test meal consumption
Primary	Desire to eat	Desire to eat as measured by visual analog scales in mm using appetite questionnaires	120 minutes after test meal consumption
Primary	Desire to eat	Desire to eat as measured by visual analog scales in mm using appetite questionnaires	180 minutes after test meal consumption
Primary	Prospective consumption	Prospective consumption as measured by visual analog scales in mm using appetite questionnaires	30 minutes after test meal consumption
Primary	Prospective consumption	Prospective consumption as measured by visual analog scales in mm using appetite questionnaires	60 minutes after test meal consumption
Primary	Prospective consumption	Prospective consumption as measured by visual analog scales in mm using appetite questionnaires	90 minutes after test meal consumption
Primary	Prospective consumption	Prospective consumption as measured by visual analog scales in mm using appetite questionnaires	120 minutes after test meal consumption
Primary	Prospective consumption	Prospective consumption as measured by visual analog scales in mm using appetite questionnaires	180 minutes after test meal consumption
Secondary	Flavor rating	Subjective ratings on liking of the product flavor using Likert scales	30 minutes after test meal consumption
Secondary	Sweetness rating	Subjective ratings on sweetness of the product using Likert scales	30 minutes after test meal consumption
Secondary	Texture rating	Subjective ratings on liking of the product texture using Likert scales	30 minutes after test meal consumption
Secondary	Overall product liking	Subjective ratings on overall liking of the product using Likert scales	30 minutes after test meal consumption
Secondary	Purchase intent	Likelihood of buying the product using Likert scales	180 minutes after test meal consumption