NCT04740112

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

January 28, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

1 month

First QC Date

January 27, 2021

Last Update Submit

March 5, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (20)

  • Hunger

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

    30 minutes after consumption

  • Hunger

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

    60 minutes after consumption

  • Hunger

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

    90 minutes after consumption

  • Hunger

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

    120 minutes after consumption

  • Hunger

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

    180 minutes after consumption

  • Fullness

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

    30 minutes after consumption

  • Fullness

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

    60 minutes after consumption

  • Fullness

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

    90 minutes after consumption

  • Fullness

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

    120 minutes after consumption

  • Fullness

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

    180 minutes after consumption

  • Desire to eat

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

    30 minutes after test meal consumption

  • Desire to eat

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

    60 minutes after test meal consumption

  • Desire to eat

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

    90 minutes after test meal consumption

  • Desire to eat

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

    120 minutes after test meal consumption

  • Desire to eat

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

    180 minutes after test meal consumption

  • Prospective consumption

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

    30 minutes after test meal consumption

  • Prospective consumption

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

    60 minutes after test meal consumption

  • Prospective consumption

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

    90 minutes after test meal consumption

  • Prospective consumption

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

    120 minutes after test meal consumption

  • Prospective consumption

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

    180 minutes after test meal consumption

Secondary Outcomes (5)

  • Flavor rating

    30 minutes after test meal consumption

  • Sweetness rating

    30 minutes after test meal consumption

  • Texture rating

    30 minutes after test meal consumption

  • Overall product liking

    30 minutes after test meal consumption

  • Purchase intent

    180 minutes after test meal consumption

Study Arms (3)

Control breakfast bar with low dietary fiber without product claims

PLACEBO COMPARATOR
Other: Foods with beta-glucan from oats and barley

Test breakfast bar with high dietary fiber without product claims

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

Test breakfast bar with high dietary fiber with product claims

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

Interventions

Foods with beta-glucan from oats and barleyOTHER

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

Also known as: Food
Control breakfast bar with low dietary fiber without product claimsTest breakfast bar with high dietary fiber with product claimsTest breakfast bar with high dietary fiber without product claims

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

No physical visit to a research facility is required.

Minneapolis, Minnesota, 55427, United States

Location

MeSH Terms

Interventions

Food

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2021

First Posted

February 5, 2021

Study Start

January 28, 2021

Primary Completion

February 28, 2021

Study Completion

June 30, 2021

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)