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

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ClinicalTrials.gov Identifier: NCT02169245
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : February 5, 2016
Sponsor:
Collaborator:
American Egg Board
Information provided by (Responsible Party):
Wayne Campbell, 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.

Condition or disease Intervention/treatment Phase
Brain Activity Appetite Ingestive Behavior Glucose Control Cholesterol Other: Dietary control of protein and fiber intake at breakfast Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official 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
Study Start Date : March 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169245


Locations
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United States, Indiana
InnerVision West/Purdue MRI Facility
West Lafayete, Indiana, United States, 47906
Purdue University
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
American Egg Board
Investigators
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Principal Investigator: Wayne W Campbell, Ph.D. Purdue University Dept of Nutrition Science
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Responsible Party: Wayne Campbell, Professor, Nutrition Science, Purdue University
ClinicalTrials.gov Identifier: NCT02169245    
Other Study ID Numbers: 1208012603
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: February 5, 2016
Last Verified: February 2016