Beta-glucan, Product Claims and Satiety

NCT ID: NCT04740112

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-28
• Study Completion Date: 2021-06-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Control breakfast bar with low dietary fiber without product claims

Group Type: PLACEBO_COMPARATOR

Foods with beta-glucan from oats and barley

Intervention Type: OTHER

Breakfast bars made with varying levels of total dietary fiber and beta-glucan, with or without claims on package image

Test breakfast bar with high dietary fiber without product claims

Group Type: EXPERIMENTAL

Foods with beta-glucan from oats and barley

Intervention Type: OTHER

Breakfast bars made with varying levels of total dietary fiber and beta-glucan, with or without claims on package image

Test breakfast bar with high dietary fiber with product claims

Group Type: EXPERIMENTAL

Foods with beta-glucan from oats and barley

Intervention Type: OTHER

Breakfast bars made with varying levels of total dietary fiber and beta-glucan, with or without claims on package image

Interventions

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

Intervention Type: OTHER

Other Intervention Names

Food

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

General Mills

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

No physical visit to a research facility is required.

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

2021/01/7

Identifier Type: -

Identifier Source: org_study_id