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Completed

NCT Number: NCT02169245

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

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.

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Key information

Conditions

Brain Activity Appetite Behavior Behavior, Animal Cholesterol Feeding Behavior Glucose Control Ingestive Behavior

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

InnerVision West/Purdue MRI Facility, West Lafayete, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary control of protein and fiber intake at breakfast

Other

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.

Primary outcomes

  1. 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

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

  • American Egg Board

Registry information

Official study title

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

Acronym: PFB

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 23, 2014
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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