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

NCT ID: NCT02169245

Last Updated: 2016-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-09-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dietary control of protein and fiber intake at breakfast

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Dietary control of protein and fiber intake at breakfast

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Dietary control of protein and fiber intake at breakfast

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Dietary control of protein and fiber intake at breakfast

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Egg Board

OTHER

Sponsor Role: collaborator

Purdue University

OTHER

Sponsor Role: lead

Responsible Party

Wayne Campbell

Professor, Nutrition Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wayne W Campbell, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Purdue University Dept of Nutrition Science

Locations

InnerVision West/Purdue MRI Facility

West Lafayete, Indiana, United States

Purdue University

West Lafayette, Indiana, United States

Countries

United States

Other Identifiers

1208012603

Identifier Type: -

Identifier Source: org_study_id