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Clinical Trials/NCT02169245
NCT02169245CompletedNot Applicable

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

Purdue University2 sites in 1 country20 target enrollmentStarted: March 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
2
Primary Endpoint
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.

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
21 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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
  • •claustrophobic
  • •any implantation unsafe in magnetic resonance imaging (MRI) environment

Arms & Interventions

Average Protein and Fiber at Breakfast

Experimental

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.

Intervention: Dietary control of protein and fiber intake at breakfast (Other)

Average Protein and High Fiber at Breakfast

Experimental

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.

Intervention: Dietary control of protein and fiber intake at breakfast (Other)

High Protein and Average Fiber at Breakfast

Experimental

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.

Intervention: Dietary control of protein and fiber intake at breakfast (Other)

Higher Protein and Fiber at Breakfast

Experimental

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.

Intervention: Dietary control of protein and fiber intake at breakfast (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 24-hour blood glucose profile(16 Weeks)
  • Fasting and postprandial blood glucose, insulin, and lipid concentrations(16 Weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Wayne Campbell

Professor, Nutrition Science

Purdue University

Study Sites (2)

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