Beta-glucan, Product Claims and Satiety

General Mills

Status: Completed

Conditions: Healthy

Treatments: Other: Foods with beta-glucan from oats and barley

Study type: Interventional

Funder types: Industry

Identifiers

NCT04740112

2021/01/7

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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130 participants in 3 patient groups, including a placebo group

Control breakfast bar with low dietary fiber without product claims

Placebo Comparator group

Treatment:

Other: Foods with beta-glucan from oats and barley

Test breakfast bar with high dietary fiber without product claims

Experimental group

Treatment:

Other: Foods with beta-glucan from oats and barley

Test breakfast bar with high dietary fiber with product claims

Experimental group

Treatment:

Other: Foods with beta-glucan from oats and barley