Exogenous ObesityFL33NCT01354574
Thermic & Lipemic Properties of Dietary Carbohydrates
A study testing High Glycemic Index meals and Low Glycemic Index meals in people with Exogenous Obesity and Dietary Modification, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Exogenous Obesity, Dietary Modification
- What is being tested?
- High Glycemic Index meals and Low Glycemic Index meals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Jun 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index between 25 and 30 kg/m2
- Having regular menses
- Willing to refrain from restrictive dieting during the course of the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Human Nutrition Research Center
Davis, California, 95616
About this study
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.
Read the 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.
- Conditions
- Exogenous Obesity, Dietary Modification
- Being tested
- High Glycemic Index meals, Low Glycemic Index meals
- Keywords
- energy metabolism, lipids, lipoproteins, satiety, glycemic load, insulin
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Glycemic Index mealsOther
Also called Low Fiber Meals
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.
Low Glycemic Index mealsOther
Also called High fiber meals
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.
| Study group | Role | What they receive |
|---|---|---|
| High Glycemic Index meals | Experimental | 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. Receives: Other: High Glycemic Index meals |
| Low Glycemic Index meals | Experimental | 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. Receives: Other: Low Glycemic Index meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Gas Exchange
Respiratory Gas Exchange will be measured using an automated metabolic cart. Gas analyzers and volumeter will be calibrated using manufacturer's procedures.
Measured: 30 minutes before a standardized test meal and intermittently for 480 minutes following the meal.
Secondary outcomes (10)
Plasma glucose
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.
Measured: 10 blood samples taken over a 480 minute period.
Circulating lipoproteins
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
Measured: 4 blood samples taken over a 480 minute period
Subjective evaluation of appetite
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.
Measured: 16 timepoints measured over 600 minutes
Food consumption at a buffet-style meal
The amount and types of foods consumed were measured after subject was presented with a buffet-style meal.
Measured: at 480 minutes following test meal
Body composition
Body composition (fat mass, % fat, lean mass, bone density) will be measured using dual energy x-ray absorptiometry.
Measured: measured the morning of the standard meal challenge
Serum insulin
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.
Measured: 10 blood samples taken over a 480 minute time period
Plasma leptin
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.
Measured: 10 blood samples taken over a 480 minute period
Plasma ghrelin
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.
Measured: 10 blood samples taken over a 480 minute time period
Cholecystokinin (CCK)
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.
Measured: 10 blood samples taken over a 480 minute time period
GLP-1
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.
Measured: 10 blood samples taken over a 480 minute time period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2011 (estimated)
- Study startOct 2002
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Exogenous ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Investigators
- Nancy L Keim, PhD, Principal investigator, USDA, ARS, WHNRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354574
- Sponsor's protocol ID
- 200210295
- Other IDs
- FL33
- Acronym
- FL33
- Status last verified
- Jul 2011
- First submitted
- 13 Aug 2010
- Last updated
- 13 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 17209178Burton-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.
PubMed 18825157
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermic & Lipemic Properties of Dietary Carbohydrates
- ClinicalTrials.gov ID
- NCT01354574
- Acronym / sponsor ID
- FL33 / 200210295
- Conditions
- Exogenous Obesity, Dietary Modification
- Keywords
- energy metabolism, lipids, lipoproteins, satiety, glycemic load, insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Study start
- Oct 2002
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 17 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Glycemic Index meals | Experimental | Other: High Glycemic Index mealsThree days of run-in diet with meals containing high glycemic index carbohydrates followed by test day with breakfast meal containing high glycemic index carbohydrates. |
| Low Glycemic Index meals | Experimental | Other: Low Glycemic Index mealsThree days of run-in diet with meals containing low glycemic index carbohydrates followed by test day with breakfast meal containing low glycemic index carbohydrates. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index between 25 and 30 kg/m2
- Having regular menses
- Willing to refrain from restrictive dieting during the course of the study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Glycemic Index mealsAlso: Low Fiber MealsDietary 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 | High Glycemic Index meals |
| Low Glycemic Index mealsAlso: High fiber mealsDietary 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 | Low Glycemic Index meals |
Primary outcome
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.
10 secondary outcomes
Plasma glucose
Time frame: 10 blood samples taken over a 480 minute period.
Circulating lipoproteins
Time frame: 4 blood samples taken over a 480 minute period
Subjective evaluation of appetite
Time frame: 16 timepoints measured over 600 minutes
Food consumption at a buffet-style meal
Time frame: at 480 minutes following test meal
Body composition
Time frame: measured the morning of the standard meal challenge
Serum insulin
Time frame: 10 blood samples taken over a 480 minute time period
Plasma leptin
Time frame: 10 blood samples taken over a 480 minute period
Plasma ghrelin
Time frame: 10 blood samples taken over a 480 minute time period
Cholecystokinin (CCK)
Time frame: 10 blood samples taken over a 480 minute time period
GLP-1
Time frame: 10 blood samples taken over a 480 minute time period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2011.
- Results publication: PubMed 17209178Motton 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.
- Results publication: PubMed 18825157Burton-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy L Keim, PhD principal investigator
USDA, ARS, WHNRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Glycemic Index meals and Low Glycemic Index meals in people with Exogenous Obesity and Dietary Modification, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Gas Exchange (time frame: 30 minutes before a standardized test meal and intermittently for 480 minutes following the meal.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01354574, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2011.