- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03083145
Protein Source, Nutrition Messaging, and Food Intake
March 13, 2017 updated by: Jamie Baum, University of Arkansas, Fayetteville
Evaluating How Breakfast Protein Source Affects Satiety, Glucose and Food Preference
The objective of this study is to determine how the protein source and the physical form of food consumed at breakfast impact food intake.
Research will be conducted by assessing feelings of hunger, food preference and blood glucose in healthy adults following the ingestion protein-based (animal versus plant) drinks similar calorie and protein content.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arkansas
-
Fayetteville, Arkansas, United States, 72704
- University of Arkansas
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy, no known health conditions
Exclusion Criteria:
- Taking medication, excluding hormonal birth control
- Food allergies
- Food intolerances
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Educational Messaging
Whey protein beverage and pea protein beverages administered in a randomized order with a one- to two-week washout period between beverages.
|
Beverage administered and postprandial appetite assessed for 2 hours followed by 1 hour monitoring of food intake from ad libitum snack tray.
Beverage administered and postprandial appetite assessed for 2 hours followed by 1 hour monitoring of food intake from ad libitum snack tray.
Items were selected from a snack tray filled with healthy and unhealthy snacks in order to determine if educational messaging influenced snack choices.
Shack choices wre recorded on a check list by a third party observer.
|
|
Active Comparator: No Messaging
Whey protein beverage and pea protein beverages administered in a randomized order with a one- to two-week washout period between beverages.
|
Beverage administered and postprandial appetite assessed for 2 hours followed by 1 hour monitoring of food intake from ad libitum snack tray.
Beverage administered and postprandial appetite assessed for 2 hours followed by 1 hour monitoring of food intake from ad libitum snack tray.
Items were selected from a snack tray filled with healthy and unhealthy snacks in order to determine if educational messaging influenced snack choices.
Shack choices wre recorded on a check list by a third party observer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Appetite assessment
Time Frame: 2 hours
|
Appetite was assessed using visual analog scales
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Snack intake using checklist
Time Frame: 1 hour
|
Snacks were provided after 2 hours and type and quantity of snacks consumed were monitored and recorded on a checklist by a member of the research team.
At the end of the snacking period, uneaten portions of snacks were weighed and recorded.
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2016
Primary Completion (Actual)
May 15, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
March 9, 2017
First Submitted That Met QC Criteria
March 13, 2017
First Posted (Actual)
March 17, 2017
Study Record Updates
Last Update Posted (Actual)
March 17, 2017
Last Update Submitted That Met QC Criteria
March 13, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 15-05-753
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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