The Breakfast Study
Breakfast
The Effects of Low and High Glycemic Index Foods and Protein on Glycemic Response and Hunger
2 other identifiers
interventional
24
1 country
1
Brief Summary
The overall objective is to investigate the effects of low and high glycemic index (GI) meals varying in protein content on plasma glucose and insulin response, subjective ratings of hunger, and subsequent food intake in twenty healthy, sedentary, overweight and obese men and women between the ages of 21-65.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2006
Typical duration for not_applicable
1 active site
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
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 3, 2008
CompletedFirst Posted
Study publicly available on registry
January 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedJuly 1, 2013
January 1, 2008
2.4 years
January 3, 2008
June 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the effects of breakfast meals containing low GI and high GI foods on glucose and insulin responses
post
Secondary Outcomes (2)
To examine the effects of low and high GI meals on subjective ratings of hunger and subsequent food intake
post
To compare the effects of high protein meals containing either low or high GI foods with high carbohydrate meals containing either low or high HI food on glucose and insulin response, subjective ratings of hunger, and subsequent food intake.
post
Study Arms (4)
Low GI
EXPERIMENTALlow GI breakfast
Low GI -low carb
EXPERIMENTALLow GI and Low carb breakfast
High GI
EXPERIMENTALHigh GI breakfast
High GI Low Carb
EXPERIMENTALhigh GI low carb breakfast
Interventions
Eligibility Criteria
You may qualify if:
- Men and women between the ages of 21-65 with a BMI of 25-40(kg/m2)
You may not qualify if:
- Individuals who are currently dieting or restricting food intake and who report pre-existing health afflictions such as diabetes, use of prescription medications, use of appetite suppressants, or regular tobacco use will be excluded from the study as they may affect appetite or impact the dependent measures of this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Temple Universitylead
- International Life Sciences Institutecollaborator
Study Sites (1)
Temple University - Center for Obesity Research and Education
Philadelphia, Pennsylvania, 19140, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Gary D Foster, PhD
Temple University - Center for Obesity Research and Education
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2008
First Posted
January 15, 2008
Study Start
January 1, 2006
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
July 1, 2013
Record last verified: 2008-01