Beta-glucan, Product Claims and Satiety

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Foods with beta-glucan from oats and barley

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55427
      • No physical visit to a research facility is required.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control breakfast bar with low dietary fiber without product claims	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; Other Names: Food
Experimental: Test breakfast bar with high dietary fiber without product claims	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; Other Names: Food
Experimental: Test breakfast bar with high dietary fiber with product claims	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; Other Names: Food

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hunger	Hunger as measured by visual analog scales in mm using appetite questionnaires	30 minutes after consumption
Hunger	Hunger as measured by visual analog scales in mm using appetite questionnaires	60 minutes after consumption
Hunger	Hunger as measured by visual analog scales in mm using appetite questionnaires	90 minutes after consumption
Hunger	Hunger as measured by visual analog scales in mm using appetite questionnaires	120 minutes after consumption
Hunger	Hunger as measured by visual analog scales in mm using appetite questionnaires	180 minutes after consumption
Fullness	Fullness as measured by visual analog scales in mm using appetite questionnaires	30 minutes after consumption
Fullness	Fullness as measured by visual analog scales in mm using appetite questionnaires	60 minutes after consumption
Fullness	Fullness as measured by visual analog scales in mm using appetite questionnaires	90 minutes after consumption
Fullness	Fullness as measured by visual analog scales in mm using appetite questionnaires	120 minutes after consumption
Fullness	Fullness as measured by visual analog scales in mm using appetite questionnaires	180 minutes after consumption
Desire to eat	Desire to eat as measured by visual analog scales in mm using appetite questionnaires	30 minutes after test meal consumption
Desire to eat	Desire to eat as measured by visual analog scales in mm using appetite questionnaires	60 minutes after test meal consumption
Desire to eat	Desire to eat as measured by visual analog scales in mm using appetite questionnaires	90 minutes after test meal consumption
Desire to eat	Desire to eat as measured by visual analog scales in mm using appetite questionnaires	120 minutes after test meal consumption
Desire to eat	Desire to eat as measured by visual analog scales in mm using appetite questionnaires	180 minutes after test meal consumption
Prospective consumption	Prospective consumption as measured by visual analog scales in mm using appetite questionnaires	30 minutes after test meal consumption
Prospective consumption	Prospective consumption as measured by visual analog scales in mm using appetite questionnaires	60 minutes after test meal consumption
Prospective consumption	Prospective consumption as measured by visual analog scales in mm using appetite questionnaires	90 minutes after test meal consumption
Prospective consumption	Prospective consumption as measured by visual analog scales in mm using appetite questionnaires	120 minutes after test meal consumption
Prospective consumption	Prospective consumption as measured by visual analog scales in mm using appetite questionnaires	180 minutes after test meal consumption

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flavor rating	Subjective ratings on liking of the product flavor using Likert scales	30 minutes after test meal consumption
Sweetness rating	Subjective ratings on sweetness of the product using Likert scales	30 minutes after test meal consumption
Texture rating	Subjective ratings on liking of the product texture using Likert scales	30 minutes after test meal consumption
Overall product liking	Subjective ratings on overall liking of the product using Likert scales	30 minutes after test meal consumption
Purchase intent	Likelihood of buying the product using Likert scales	180 minutes after test meal consumption

Collaborators and Investigators

• Sponsor: General Mills

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2021
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2021/01/7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No