- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01354574
Thermic & Lipemic Properties of Dietary Carbohydrates (FL33)
July 12, 2011 updated by: USDA, Western Human Nutrition Research Center
The purpose of this study is to determine if consumption of meals containing carbohydrates with different glycemic index (a high glycemic index meal and a low glycemic index meal)have different effects on energy expenditure, type of metabolic fuels used for energy, blood lipids and lipoproteins, and sensations of hunger, fullness, and the hormones related to satiety.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Little is known about the metabolic effects of chronic dieting and weight cycling in humans, but limited evidence suggests that fatty acid oxidation may be depressed leading to periodic elevation of circulating lipids associated with meal ingestion and preferential storage of fat in adipose tissue.
With the traditional approach of restrictive dieting failing to result in permanent weight loss and, possibly producing abnormalities in lipid metabolism, it is important to evaluate alternative approaches to achieve a healthy body weight through improved metabolism.
In this study the investigators will test the postprandial metabolic effects of standard mixed meals containing carbohydrates with high glycemic index and compare these effects to responses obtained with standard mixed meals, matched for protein and fat content but containing carbohydrates with low glycemic index.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Davis, California, United States, 95616
- Western Human Nutrition Research Center
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-
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 48 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Body mass index between 25 and 30 kg/m2
- Having regular menses
- Willing to refrain from restrictive dieting during the course of the study
Exclusion Criteria:
- Pregnant or currently planning a pregnancy
- Cigarette smoking
- Taking medications to induce weight loss or change appetite
- History of cardiovascular disease
- History of metabolic disorders, including diabetes
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
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High Glycemic Index meals
Three days of run-in diet with meals containing high glycemic index carbohydrates followed by test day with breakfast meal containing high glycemic index carbohydrates.
|
Dietary intervention with meals containing high glycemic index carbohydrates.
All foods provided to meet the individual's energy needs.
Standardized test meal (breakfast)also contained only high glycemic index carbohydrates and energy content was adjusted for each individual, providing 40% of daily energy needs.
Other Names:
|
|
Experimental: Low Glycemic Index meals
Three days of run-in diet with meals containing low glycemic index carbohydrates followed by test day with breakfast meal containing low glycemic index carbohydrates.
|
Dietary intervention with meals containing low glycemic index carbohydrates.
All foods provided to meet the individual's energy needs.
Standardized test meal (breakfast)also contained only low glycemic index carbohydrates and energy content was adjusted for each individual, providing 40% of daily energy needs.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respiratory Gas Exchange
Time Frame: 30 minutes before a standardized test meal and intermittently for 480 minutes following the meal.
|
Respiratory Gas Exchange will be measured using an automated metabolic cart.
Gas analyzers and volumeter will be calibrated using manufacturer's procedures.
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30 minutes before a standardized test meal and intermittently for 480 minutes following the meal.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plasma glucose
Time Frame: 10 blood samples taken over a 480 minute period.
|
1 fasting blood sample (0 minutes) and 9 post-prandial blood samples taken at 30, 60, 90, 120, 150, 210, 270, 360 and 480 minutes following consumption of standardized test meal.
|
10 blood samples taken over a 480 minute period.
|
|
Circulating lipoproteins
Time Frame: 4 blood samples taken over a 480 minute period
|
Blood samples for lipoprotein analyses were taken at fasting (0 minute) and at 150, 210, and 480 minutes following consumption of test meal.
A subset of 10 randomly-selected subjects was chosen for this outcome measure
|
4 blood samples taken over a 480 minute period
|
|
Subjective evaluation of appetite
Time Frame: 16 timepoints measured over 600 minutes
|
Visual analog scales were used to assess appetite-related sensations.
Four responses were obtained during the fasting phase (120 minutes) and 12 responses were obtained in the 480 minute postprandial period.
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16 timepoints measured over 600 minutes
|
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Food consumption at a buffet-style meal
Time Frame: at 480 minutes following test meal
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The amount and types of foods consumed were measured after subject was presented with a buffet-style meal.
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at 480 minutes following test meal
|
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Body composition
Time Frame: measured the morning of the standard meal challenge
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Body composition (fat mass, % fat, lean mass, bone density) will be measured using dual energy x-ray absorptiometry.
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measured the morning of the standard meal challenge
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|
Serum insulin
Time Frame: 10 blood samples taken over a 480 minute time period
|
1 fasting blood sample (0 minutes) and 9 post-prandial blood samples taken at 30, 60, 90, 120, 150, 210, 270, 360 and 480 minutes following consumption of test meal.
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10 blood samples taken over a 480 minute time period
|
|
Plasma leptin
Time Frame: 10 blood samples taken over a 480 minute period
|
1 fasting blood sample (0 minutes) and 9 post-prandial blood samples taken at 30, 60, 90, 120, 150, 210, 270, 360 and 480 minutes following consumption of test meal.
|
10 blood samples taken over a 480 minute period
|
|
Plasma ghrelin
Time Frame: 10 blood samples taken over a 480 minute time period
|
1 fasting blood sample (0 minutes) and 9 post-prandial blood samples taken at 30, 60, 90, 120, 150, 210, 270, 360 and 480 minutes following consumption of test meal.
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10 blood samples taken over a 480 minute time period
|
|
Cholecystokinin (CCK)
Time Frame: 10 blood samples taken over a 480 minute time period
|
1 fasting blood sample (0 minutes) and 9 post-prandial blood samples taken at 30, 60, 90, 120, 150, 210, 270, 360 and 480 minutes following consumption of test meal.
|
10 blood samples taken over a 480 minute time period
|
|
GLP-1
Time Frame: 10 blood samples taken over a 480 minute time period
|
1 fasting blood sample (0 minutes) and 9 post-prandial blood samples taken at 30, 60, 90, 120, 150, 210, 270, 360 and 480 minutes following consumption of test meal.
|
10 blood samples taken over a 480 minute time period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nancy L Keim, PhD, USDA, ARS, WHNRC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Motton DD, Keim NL, Tenorio FA, Horn WF, Rutledge JC. Postprandial monocyte activation in response to meals with high and low glycemic loads in overweight women. Am J Clin Nutr. 2007 Jan;85(1):60-5. doi: 10.1093/ajcn/85.1.60.
- Burton-Freeman BM, Keim NL. Glycemic index, cholecystokinin, satiety and disinhibition: is there an unappreciated paradox for overweight women? Int J Obes (Lond). 2008 Nov;32(11):1647-54. doi: 10.1038/ijo.2008.159. Epub 2008 Sep 30.
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
October 1, 2002
Primary Completion (Actual)
June 1, 2005
Study Completion (Actual)
June 1, 2005
Study Registration Dates
First Submitted
August 13, 2010
First Submitted That Met QC Criteria
May 16, 2011
First Posted (Estimate)
May 17, 2011
Study Record Updates
Last Update Posted (Estimate)
July 13, 2011
Last Update Submitted That Met QC Criteria
July 12, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- 200210295
- FL33 (Other Identifier: USDA-ARS-WHNRC)
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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