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

Appetite Clinical Trial

— PFB  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02169245
• Other study ID #: 1208012603
• Status: Completed
• Phase: N/A
• First received: March 20, 2014
• Last updated: February 4, 2016
• Start date: March 2014
• Est. completion date: September 2015

Study information

• Verified date: February 2016
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Appetite
• Brain Activity
• Cholesterol
• Glucose Control
• Ingestive Behavior

Intervention

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.

Locations

Country	Name	City	State
United States	InnerVision West/Purdue MRI Facility	West Lafayete	Indiana
United States	Purdue University	West Lafayette	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Purdue University	American Egg Board

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	No
Secondary	24-hour blood glucose profile	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	No
Secondary	Fasting and postprandial blood glucose, insulin, and lipid concentrations	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	No