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
Verified date | March 2024 |
Source | General Mills |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | No physical visit to a research facility is required. | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
General Mills |
United States,
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 |
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