Beta-glucan, Product Claims and Satiety

• Sponsor: General Mills (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04740112
• Collaborator: (none)
• Enrollment: 130
• Location: 1
• Arms: 3
• Actual Duration (Months): 5
• Patients Per Site Per Month: 25.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Foods with beta-glucan from oats and barley	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Effects of Beta-glucan and Product Claims for Breakfast Bars on Appetite Response and Consumer Preference: a Randomized Controlled Trial
• Actual Study Start Date: Jan 28, 2021
• Actual Primary Completion Date: Feb 28, 2021
• Actual Study Completion Date: Jun 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Hunger [30 minutes after consumption]

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

2. Hunger [60 minutes after consumption]

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

3. Hunger [90 minutes after consumption]

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

4. Hunger [120 minutes after consumption]

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

5. Hunger [180 minutes after consumption]

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

6. Fullness [30 minutes after consumption]

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

7. Fullness [60 minutes after consumption]

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

8. Fullness [90 minutes after consumption]

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

9. Fullness [120 minutes after consumption]

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

10. Fullness [180 minutes after consumption]

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

11. Desire to eat [30 minutes after test meal consumption]

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

12. Desire to eat [60 minutes after test meal consumption]

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

13. Desire to eat [90 minutes after test meal consumption]

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

14. Desire to eat [120 minutes after test meal consumption]

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

15. Desire to eat [180 minutes after test meal consumption]

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

16. Prospective consumption [30 minutes after test meal consumption]

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

17. Prospective consumption [60 minutes after test meal consumption]

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

18. Prospective consumption [90 minutes after test meal consumption]

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

19. Prospective consumption [120 minutes after test meal consumption]

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

20. Prospective consumption [180 minutes after test meal consumption]

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

Secondary Outcome Measures

1. Flavor rating [30 minutes after test meal consumption]

   Subjective ratings on liking of the product flavor using Likert scales

2. Sweetness rating [30 minutes after test meal consumption]

   Subjective ratings on sweetness of the product using Likert scales

3. Texture rating [30 minutes after test meal consumption]

   Subjective ratings on liking of the product texture using Likert scales

4. Overall product liking [30 minutes after test meal consumption]

   Subjective ratings on overall liking of the product using Likert scales

5. Purchase intent [180 minutes after test meal consumption]

   Likelihood of buying the product using Likert scales

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	No physical visit to a research facility is required.	Minneapolis	Minnesota	United States	55427

Sponsors and Collaborators

• General Mills

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yong Zhu, Principal Investigator, General Mills
• ClinicalTrials.gov Identifier: NCT04740112
• Other Study ID Numbers: 2021/01/7
• First Posted: Feb 5, 2021
• Last Update Posted: Jul 12, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 12, 2021