Effect of Different Fiber Breakfasts on Appetite and Weight Change in Overweight Subjects

January 10, 2014 updated by: Dr. Allan Geliebter, New York Obesity and Nutrition Research Center

The Effect of Ingesting Breakfasts Varying in Fiber on Appetite and Weight Change in Overweight Subjects

Regular breakfast consumption may help lower body weight reduce body fatness and improve cardiovascular disease risk factors. However, the best kind of breakfast to consume to achieve these effects is unclear. We hypothesized that a high fiber breakfast would suppress appetite, lower body weight and improve cardiovascular disease risk factors compared with a no-fiber breakfast.

Study Overview

Detailed Description

Participants will report to the hospital cafeteria between 0800 and 0900h following an overnight fast every weekday for 4 consecutive weeks. On arrival, participants will be provided will the allocated breakfast and will be given 15 min to consume all the foods provided. The oatmeal breakfast will consist of 80g dry oatmeal (Quaker Quick Oats) prepared with 120mL fat-free milk and 230mL water. The frosted flakes breakfast will consist of 62g frosted flakes and 160mL whole milk and 190mL water served on the side. The No-breakfast (control) will consist of only 350mL plain water. All participants will also receive 200mL decaffeinated coffee with 12mL non-dairy creamer and 1g packet of non-caloric sweetener. On Friday of each week participants will be provided with two portions of the breakfasts to take home at consume on the weekend days. On the first day of the intervention and weekly thereafter participants will complete 3hr subjective appetite ratings responses to the breakfast. Laboratory assessments including body weight, composition, blood pressure and a fasting blood sample will be collected before the start of the intervention and at the end of the intervention.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI >27kg/m2
  • Weight stable (<5% weight change in past 3 months)

Exclusion Criteria:

  • Smokers
  • Regular use of medications
  • Currently undertaking a weight-loss or exercise program
  • Females who are pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oatmeal Breakfast
Participants will consume oatmeal breakfast daily for 4 weeks
A breakfast consisting of oatmeal
Other Names:
  • Quaker Quick Oats
Experimental: Frosted Flakes
Participants will consume a frosted flakes breakfast daily for 4-weeks
A breakfast consisting of Frosted Flakes and milk
Other Names:
  • Kelloggs Frosted Flakes
Placebo Comparator: No Breakfast
Participants will consume no breakfast for a 4-week period
A breakfast consisting of plain water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body weight
Time Frame: Change in body weight over 4 week intervention
Body weight will be measured at baseline and following 4-week breakfast intervention
Change in body weight over 4 week intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective appetite
Time Frame: Appetite ratings in response to breakfast will be collected for 3hs on the first day of the study and after 1, 2, 3 and 4 weeks of the intervention
Ratings of hunger and Fullness will be collected on a 6 point rating scale with 0 labelled not at all, 40 moderately, 60 quite, 80 very and 100 extremely.
Appetite ratings in response to breakfast will be collected for 3hs on the first day of the study and after 1, 2, 3 and 4 weeks of the intervention
Change in plasma metabolic risk factors
Time Frame: At baseline and following 4-week intervention
A fasting blood sample will be collected and analyzed for glucose, insulin, triacylglycerol, leptin and cholesterol
At baseline and following 4-week intervention
Resting Energy Expenditure
Time Frame: Resting energy expenditure will be measured at baseline and following the 4 week intervention
Resting energy expenditure measurements will be collected whilst subjects are fasting, resting in a semi-supine position under thermoneutral conditions with a ventilated hood and metabolic cart.
Resting energy expenditure will be measured at baseline and following the 4 week intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: At baseline and following 4-week intervention
Systolic and diastolic blood pressure will be measured at baseline and following 4-week intervention
At baseline and following 4-week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Allan Geliebter, PhD, New York Obesity Nutrition Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1998

Primary Completion (Actual)

February 1, 2000

Study Completion (Actual)

December 1, 2002

Study Registration Dates

First Submitted

January 8, 2014

First Submitted That Met QC Criteria

January 10, 2014

First Posted (Estimate)

January 14, 2014

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 10, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98-022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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