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

Not Applicable

Completed

• Conditions: Appetite; Glucose Control; Brain Activity; Ingestive Behavior; Cholesterol

• Registration Number: NCT02169245
• Lead Sponsor: Purdue University

Brief Summary

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.

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 Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-20
• Study First Submitted QC: 2014-06-18
• Study First Posted: 2014-06-23
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-04
• Last Update Posted: 2016-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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.	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.

Secondary Outcome Measures

Name	Time	Method
24-hour blood glucose profile	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.
Fasting and postprandial blood glucose, insulin, and lipid concentrations	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.

Trial Locations

Locations (2)

InnerVision West/Purdue MRI Facility; 🇺🇸 West Lafayete, Indiana, United States

Purdue University; 🇺🇸 West Lafayette, Indiana, United States