ObesityNCT00130299
An 18-month Trial of a Low Glycemic Load Diet
A study testing low glycemic load diet and low fat diet in people with Obesity, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The primary aim of this study is to compare the effects of an experimental low-glycemic load diet with those of a conventional low-fat diet among obese young adults in an 18-month randomized-controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- low glycemic load diet and low fat diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Dec 2006
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 35 years
- Body mass index (BMI) ≥ 30 kg/m2
- Access to a working telephone
- Conversant in English
- Written medical clearance from a primary care physician or nurse practitioner, ruling out any pre-existing or complicating medical condition
Who cannot join
- Body weight >300 lbs
- Major medical illness (heart, kidney or liver disease; diabetes; cancer; endocrinopathy; psychiatric illness) or other active medical problem
- An obesity-associated genetic syndrome (e.g., Prader-Willi)
- An abnormal screening laboratory test (ALT, creatinine, BUN, hematocrit)
- Fasting blood glucose ≥ 126 mg/dl)
- Taking any prescription medication that affects body weight (glucocorticoids, neuropsychiatric agents), blood pressure, or serum cholesterol concentrations
Show all 10Show fewer
- Currently smoking (1 cigarette during any of the last 7 days)
- Previous diagnosis of an eating disorder (anorexia nervosa, bulimia, binge-eating disorder)
- If female, not pregnant or planning to become pregnant in the next 18 months and not lactating
- Failure to complete the pre-enrollment visits
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: An 18-month Randomized Controlled Trial of a Low Glycemic Load Diet
The primary aim of this study is to compare the effects of an experimental low-glycemic load diet with those of a conventional low-fat diet among obese young adults in an 18-month randomized-controlled trial.
Read the detailed description
The prevalence of obesity has risen dramatically among children in the U.S. since the 1960s. Effective treatment of childhood obesity is widely recognized as instrumental to public health efforts to combat type 2 diabetes and heart disease. Evidence from animal studies, short-term human studies and epidemiology suggests that diets designed to minimize the rise in postprandial blood glucose, that is low glycemic index, may be useful in the treatment of obesity and related complications. This project proposes an month RCT comparing a low glycemic load diet to a conventional low fat diet. Both diet groups will receive identical treatment intensity, behavioral modification and physical activity recommendations. The primary endpoint will be change in percent body fat by dexa-scan at 18 months; other outcomes include insulin resistance and CVD risk factors. Compliance will be assessed by interviewer-administered, 24-hour dietary recalls.
- Conditions
- Obesity
- Being tested
- low glycemic load diet, low fat diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low glycemic load dietBehavioural
low fat dietBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
change in adiposity as measured by dual energy x-ray absorptiometry (DEXA).
Secondary outcomes (1)
change in insulin resistance as measured by the homeostasis model assessment; change in glucose tolerance as measured by an oral glucose tolerance test (OGTT); change in cardiovascular disease risk factors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2005 (estimated)
- Study startJul 2004
- Study completionDec 2006
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 ObesityStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Charles H. Hood Foundation
- Investigators
- David S Ludwig, MD, PhD, Principal investigator, Boston Children's HospitalCara B Ebbeling, PhD, Study director, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00130299
- Sponsor's protocol ID
- 59240-#1
- Other IDs
- R01DK059240
- Status last verified
- Aug 2010
- First submitted
- 12 Aug 2005
- Last updated
- 30 Aug 2010
- Results posted
- No
Publications
Ebbeling CB, Leidig MM, Sinclair KB, Seger-Shippee LG, Feldman HA, Ludwig DS. Effects of an ad libitum low-glycemic load diet on cardiovascular disease risk factors in obese young adults. Am J Clin Nutr. 2005 May;81(5):976-82. doi: 10.1093/ajcn/81.5.976.
PubMed 15883418Ebbeling CB, Leidig MM, Feldman HA, Lovesky MM, Ludwig DS. Effects of a low-glycemic load vs low-fat diet in obese young adults: a randomized trial. JAMA. 2007 May 16;297(19):2092-102. doi: 10.1001/jama.297.19.2092.
PubMed 17507345
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 18-month Randomized Controlled Trial of a Low Glycemic Load Diet
- ClinicalTrials.gov ID
- NCT00130299
- Acronym / sponsor ID
- 59240-#1
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Charles H. Hood Foundation
- Study start
- Jul 2004
- Study completion
- Dec 2006 (actual)
- First posted
- 15 Aug 2005 (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 primary aim of this study is to compare the effects of an experimental low-glycemic load diet with those of a conventional low-fat diet among obese young adults in an 18-month randomized-controlled trial.
Detailed description
The prevalence of obesity has risen dramatically among children in the U.S. since the 1960s. Effective treatment of childhood obesity is widely recognized as instrumental to public health efforts to combat type 2 diabetes and heart disease. Evidence from animal studies, short-term human studies and epidemiology suggests that diets designed to minimize the rise in postprandial blood glucose, that is low glycemic index, may be useful in the treatment of obesity and related complications. This project proposes an month RCT comparing a low glycemic load diet to a conventional low fat diet. Both diet groups will receive identical treatment intensity, behavioral modification and physical activity recommendations. The primary endpoint will be change in percent body fat by dexa-scan at 18 months; other outcomes include insulin resistance and CVD risk factors. Compliance will be assessed by interviewer-administered, 24-hour dietary recalls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 to 35 years
- Body mass index (BMI) ≥ 30 kg/m2
- Access to a working telephone
- Conversant in English
- Written medical clearance from a primary care physician or nurse practitioner, ruling out any pre-existing or complicating medical condition
Key exclusion criteria (10 listed)
- Body weight >300 lbs
- Major medical illness (heart, kidney or liver disease; diabetes; cancer; endocrinopathy; psychiatric illness) or other active medical problem
- An obesity-associated genetic syndrome (e.g., Prader-Willi)
- An abnormal screening laboratory test (ALT, creatinine, BUN, hematocrit)
- Fasting blood glucose ≥ 126 mg/dl)
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 |
|---|---|---|
| low glycemic load diet | Behavioural | – |
| low fat diet | Behavioural | – |
Primary outcome
change in adiposity as measured by dual energy x-ray absorptiometry (DEXA).
1 secondary outcome
change in insulin resistance as measured by the homeostasis model assessment; change in glucose tolerance as measured by an oral glucose tolerance test (OGTT); change in cardiovascular disease risk factors
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 30 Aug 2010.
- Background: PubMed 15883418Ebbeling CB, Leidig MM, Sinclair KB, Seger-Shippee LG, Feldman HA, Ludwig DS. Effects of an ad libitum low-glycemic load diet on cardiovascular disease risk factors in obese young adults. Am J Clin Nutr. 2005 May;81(5):976-82. doi: 10.1093/ajcn/81.5.976.
- Results publication: PubMed 17507345Ebbeling CB, Leidig MM, Feldman HA, Lovesky MM, Ludwig DS. Effects of a low-glycemic load vs low-fat diet in obese young adults: a randomized trial. JAMA. 2007 May 16;297(19):2092-102. doi: 10.1001/jama.297.19.2092.
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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.
David S Ludwig, MD, PhD principal investigator
Boston Children's Hospital
Cara B Ebbeling, PhD study director
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low glycemic load diet and low fat diet in people with Obesity, run by Boston Children's Hospital 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 5 inclusion and 10 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 30 Aug 2010. 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?
change in adiposity as measured by dual energy x-ray absorptiometry (DEXA).. 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 NCT00130299, 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 30 Aug 2010.