- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02035150
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
Status
Completed
Conditions
Intervention / Treatment
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:
|
Experimental: Frosted Flakes
Participants will consume a frosted flakes breakfast daily for 4-weeks
|
A breakfast consisting of Frosted Flakes and milk
Other Names:
|
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
Keywords
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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