NCT02169245

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

February 5, 2016

Status Verified

February 1, 2016

Enrollment Period

1.5 years

First QC Date

March 20, 2014

Last Update Submit

February 4, 2016

Conditions

Brain ActivityAppetiteIngestive BehaviorGlucose ControlCholesterol

Outcome Measures

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.

    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

Secondary Outcomes (2)

  • 24-hour blood glucose profile

    16 Weeks

  • Fasting and postprandial blood glucose, insulin, and lipid concentrations

    16 Weeks

Study Arms (4)

Average Protein and Fiber at Breakfast

EXPERIMENTAL

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

Average Protein and High Fiber at Breakfast

EXPERIMENTAL

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

High Protein and Average Fiber at Breakfast

EXPERIMENTAL

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

Higher Protein and Fiber at Breakfast

EXPERIMENTAL

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

Interventions

Dietary control of protein and fiber intake at breakfastOTHER

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 Fiber at BreakfastAverage Protein and High Fiber at BreakfastHigh Protein and Average Fiber at BreakfastHigher Protein and Fiber at Breakfast

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male or female
  • age 21 - 45 years
  • BMI 25-29.9 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

InnerVision West/Purdue MRI Facility

West Lafayete, Indiana, 47906, United States

Location

Purdue University

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Wayne W Campbell, Ph.D.

    Purdue University Dept of Nutrition Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Nutrition Science

Study Record Dates

First Submitted

March 20, 2014

First Posted

June 23, 2014

Study Start

March 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

February 5, 2016

Record last verified: 2016-02

Locations

US(2)