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Completed

NCT Number: NCT04740112

Beta-glucan, Product Claims and Satiety

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.

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Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

No physical visit to a research facility is required.

Minneapolis, Minnesota, 55427, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Foods with beta-glucan from oats and barley

Other

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

Other names: Food

Primary outcomes

  1. Hunger

    Time frame: 30 minutes after consumption

    Hunger as measured by visual analog scales in mm using appetite questionnaires

  2. Hunger

    Time frame: 60 minutes after consumption

    Hunger as measured by visual analog scales in mm using appetite questionnaires

  3. Hunger

    Time frame: 90 minutes after consumption

    Hunger as measured by visual analog scales in mm using appetite questionnaires

  4. Hunger

    Time frame: 120 minutes after consumption

    Hunger as measured by visual analog scales in mm using appetite questionnaires

  5. Hunger

    Time frame: 180 minutes after consumption

    Hunger as measured by visual analog scales in mm using appetite questionnaires

  6. Fullness

    Time frame: 30 minutes after consumption

    Fullness as measured by visual analog scales in mm using appetite questionnaires

  7. Fullness

    Time frame: 60 minutes after consumption

    Fullness as measured by visual analog scales in mm using appetite questionnaires

  8. Fullness

    Time frame: 90 minutes after consumption

    Fullness as measured by visual analog scales in mm using appetite questionnaires

  9. Fullness

    Time frame: 120 minutes after consumption

    Fullness as measured by visual analog scales in mm using appetite questionnaires

  10. Fullness

    Time frame: 180 minutes after consumption

    Fullness as measured by visual analog scales in mm using appetite questionnaires

  11. Desire to eat

    Time frame: 30 minutes after test meal consumption

    Desire to eat as measured by visual analog scales in mm using appetite questionnaires

  12. Desire to eat

    Time frame: 60 minutes after test meal consumption

    Desire to eat as measured by visual analog scales in mm using appetite questionnaires

  13. Desire to eat

    Time frame: 90 minutes after test meal consumption

    Desire to eat as measured by visual analog scales in mm using appetite questionnaires

  14. Desire to eat

    Time frame: 120 minutes after test meal consumption

    Desire to eat as measured by visual analog scales in mm using appetite questionnaires

  15. Desire to eat

    Time frame: 180 minutes after test meal consumption

    Desire to eat as measured by visual analog scales in mm using appetite questionnaires

  16. Prospective consumption

    Time frame: 30 minutes after test meal consumption

    Prospective consumption as measured by visual analog scales in mm using appetite questionnaires

  17. Prospective consumption

    Time frame: 60 minutes after test meal consumption

    Prospective consumption as measured by visual analog scales in mm using appetite questionnaires

  18. Prospective consumption

    Time frame: 90 minutes after test meal consumption

    Prospective consumption as measured by visual analog scales in mm using appetite questionnaires

  19. Prospective consumption

    Time frame: 120 minutes after test meal consumption

    Prospective consumption as measured by visual analog scales in mm using appetite questionnaires

  20. Prospective consumption

    Time frame: 180 minutes after test meal consumption

    Prospective consumption as measured by visual analog scales in mm using appetite questionnaires

Secondary outcomes

  1. Flavor rating

    Time frame: 30 minutes after test meal consumption

    Subjective ratings on liking of the product flavor using Likert scales

  2. Sweetness rating

    Time frame: 30 minutes after test meal consumption

    Subjective ratings on sweetness of the product using Likert scales

  3. Texture rating

    Time frame: 30 minutes after test meal consumption

    Subjective ratings on liking of the product texture using Likert scales

  4. Overall product liking

    Time frame: 30 minutes after test meal consumption

    Subjective ratings on overall liking of the product using Likert scales

  5. Purchase intent

    Time frame: 180 minutes after test meal consumption

    Likelihood of buying the product using Likert scales

Sponsors and collaborators

Lead sponsor

General Mills

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2021
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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