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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02169245
Other study ID # 1208012603
Secondary ID
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


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
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