Effects of Protein and Fiber at Breakfast on Appetite, Blood Sugar, and Cholesterol (PFB)

February 4, 2016 updated by: Wayne Campbell, Purdue University

Relative Effects of Chronic Consumption of Egg Protein at Breakfast With and Without Fiber on Brain Neural Activation, Appetite, Glycemic and Lipemic Control and Self-selected Energy Intake

The objectives of the research are to assess the effects of increased protein and fiber intake at breakfast on neural activation in brain regions associated with appetitive drive and reward-driven eating, measures of subjective appetite, and ingestive behavior in overweight adults. Additional outcomes of interest include the effects of the breakfast intervention on blood sugar and cholesterol profiles.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objectives of the research are to assess the effects of increased protein and fiber intake at breakfast on neural activation in brain regions associated with appetitive drive and reward-driven eating, measures of subjective appetite, and ingestive behavior in overweight adults. Additional outcomes of interest include the effects of the breakfast intervention on 24-hour glucose profile as well as fasting and postprandial glycemic and lipemic regulation. The investigators will test the effects of consuming breakfasts with normal protein/normal fiber (NPNF), normal protein/high fiber (NPHF), high protein/normal fiber (HPNF), and high protein/high fiber (HPHF) for two weeks in a randomized cross-over study.

Study Type

Interventional

Enrollment (Actual)

20

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

  • United States
    • Indiana
      • West Lafayete, Indiana, United States, 47906
        • InnerVision West/Purdue MRI Facility
      • West Lafayette, Indiana, United States, 47907
        • Purdue University

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

21 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male or female
  • age 21 - 45 years
  • BMI 25-29.9 kg/m2

Exclusion Criteria:

  • Irregular menstrual cycles
  • current smoker
  • medications or supplements that affect appetite
  • pregnant or lactating
  • not weight stable
  • acutely ill
  • diabetic
  • claustrophobic
  • any implantation unsafe in magnetic resonance imaging (MRI) environment

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Average Protein and Fiber at Breakfast
Dietary control of protein and fiber intake at breakfast. Participants will eat a 400 kcal breakfast with an average amount of protein and fiber for this age group for 2 weeks.
Other: Dietary control of protein and fiber intake at breakfast
Participants will be provided breakfast meals for 4, 2 week long interventions. The intervention arms are 1) average protein and fiber, 2) average protein and high fiber, 3) high protein and average fiber, and 4) high protein and fiber.
Experimental: Average Protein and High Fiber at Breakfast
Dietary control of protein and fiber intake at breakfast. Participants will eat a 400 kcal breakfast with an average amount of protein and higher than average amount of fiber for this age group for 2 weeks.
Other: Dietary control of protein and fiber intake at breakfast
Participants will be provided breakfast meals for 4, 2 week long interventions. The intervention arms are 1) average protein and fiber, 2) average protein and high fiber, 3) high protein and average fiber, and 4) high protein and fiber.
Experimental: High Protein and Average Fiber at Breakfast
Dietary control of protein and fiber intake at breakfast. Participants will eat a 400 kcal breakfast with an average amount of fiber and higher than average amount of protein for this age group for 2 weeks.
Other: Dietary control of protein and fiber intake at breakfast
Participants will be provided breakfast meals for 4, 2 week long interventions. The intervention arms are 1) average protein and fiber, 2) average protein and high fiber, 3) high protein and average fiber, and 4) high protein and fiber.
Experimental: Higher Protein and Fiber at Breakfast
Dietary control of protein and fiber intake at breakfast. Participants will eat a 400 kcal breakfast with a higher than average amount of protein and fiber for this age group for 2 weeks.
Other: Dietary control of protein and fiber intake at breakfast
Participants will be provided breakfast meals for 4, 2 week long interventions. The intervention arms are 1) average protein and fiber, 2) average protein and high fiber, 3) high protein and average fiber, and 4) high protein and fiber.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain activation measured with functional magnetic resonance imaging and its association with measures subjective of appetite, self-selected daily energy intake, and energy intake at an ad libitum lunch.
Time Frame: 16 weeks
Aim 1: Assess the effects of a higher than normal protein and fiber intake at breakfast on neural activation of brain regions associated with appetitive drive and reward-driven eating, measures subjective of appetite, self-selected daily energy intake, and energy intake at an ad libitum lunch.
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour blood glucose profile
Time Frame: 16 Weeks
Aim 2: Assess the effects of higher than normal protein and fiber intake at breakfast on 24-hour glucose profile using a continuous glucose monitoring system.
16 Weeks
Fasting and postprandial blood glucose, insulin, and lipid concentrations
Time Frame: 16 Weeks
Aim 3: Assess the effects of higher than normal protein and fiber intake at breakfast on fasting and postprandial glycemic and lipemic regulation.
16 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue University

Collaborators

American Egg Board

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

March 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

March 20, 2014

First Submitted That Met QC Criteria

June 18, 2014

First Posted (Estimate)

June 23, 2014

Study Record Updates

Last Update Posted (Estimate)

February 5, 2016

Last Update Submitted That Met QC Criteria

February 4, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 1208012603

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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