ObesityNCT01064778
Glycemic Index and Brain Function
A study testing Low GI and High GI in people with Obesity, run by Beth Israel Deaconess Medical Center at 3 sites in United States.
Trial summary
The investigators propose examine the effects of the dietary factor glycemic index (GI) on brain areas that control food intake and hunger. This knowledge could help design dietary approaches that decrease hunger, and thus promote new weight loss strategies. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Low GI and High GI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2010to Sep 2011
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males age 18 to 35 years
- BMI less than or equal to 25 for age and gender
Who cannot join
- weight > 300 lbs
- largest body circumference > 144cm
- body shape incompatible with MRI scanner or equipment
- MRI exclusion criteria
- large fluctuations in body weight (5% over preceding 6 months, 2.5% during the study)
- known medical problems that may affect metabolism or hormones
Show all 13Show fewer
- diabetes mellitus (fasting plasma glucose ≥126 mg/dL)
- other abnormal laboratory screening tests
- taking any medications or dietary supplements that might affect body weight, appetite, or energy expenditure
- smoking or illicit substance abuse
- high levels of physical activity (>30 minutes per day, > 4days per week)
- currently following a weight loss diet
- allergies or intolerance to eggs, vanilla extract, equal, canola oil, milk, cornstarch, corn syrup
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Children's Hospital Boston
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Brigham and Women's Hospital
Boston, Massachusetts, 02215
About this study
Official title: The Effects of Dietary Glycemic Index on Brain Function
The investigators propose examine the effects of the dietary factor glycemic index (GI) on brain areas that control food intake and hunger. This knowledge could help design dietary approaches that decrease hunger, and thus promote new weight loss strategies.
Read the detailed description
Most individuals have great difficulty following reduced calorie diets because they experience increased hunger. This process is regulated by specific brain areas. Though many psychological and environmental factors are involved, physiological effects of diet may have a significant impact. The postprandial rise in blood glucose, quantified by the glycemic index (GI), is of particular interest. High GI meals elicit hormonal events that limit availability of metabolic fuels, causing hunger and overeating, especially in people with high insulin secretion.
Our aim is to examine how postprandial changes after high versus low GI meals affect hunger and brain function in areas of intake control. Specifically, we speculate that obese individuals will demonstrate functional changes in brain areas of intake control and increased hunger after a high versus low GI meal.
We will recruit obese, young adults and quantify their insulin secretion during a 2-hour oral glucose tolerance test. A brief practice MRI session will serve to familiarize the subjects with the scanning process. During the two test sessions, standardized test meals with high versus low GI will be given in a randomized, blinded cross-over design. Serial blood levels of hormones, metabolic fuels, and metabolites will be correlated with perceived hunger, and a perfusion MRI scan will be performed to assess brain activation during the late postprandial phase, at the nadir of blood sugar and insulin levels (4 hours postprandial).
This work will inform an integrated physiological model relating peripheral postprandial changes to brain function and hunger. In addition, findings may provide evidence of a novel diet-phenotype, in which baseline clinical characteristics can be used to predict which weight loss diet will work best for a specific individual. Metabolite profiling might shed light on the mechanisms linking diet composition to brain function, and provide feasible clinical markers of the identified phenotype to facilitate translation into practice.
- Conditions
- Obesity
- Being tested
- Low GI, High GI
- Keywords
- Glycemic Index, Brain, Intake Regulation, Weight Loss, Hunger, Diet
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low GIOther
Subjects will be instructed to consume a liquid test meal with a low GI over 5 minutes after baseline laboratory evaluations. The low and high GI meal contain similar amounts of milk, oil, dried egg whites, equal, and vanilla extract. The low GI meal corn-starch as a carbohydrate. Both meals have similar macronutrient composition (60% carbohydrate, 15% protein, 25% fat), micronutrient profiles, physical properties, palatability and sweetness. The high vs. low GI meals have a predicted difference in GI of 90 vs. 40, and consistent with this prediction, a pilot study in obese young adults found a 2.2-fold difference in glycemic response (p<0.001). The test meals will provide 25% of individual daily energy requirements.
High GIOther
Subjects will be instructed to consume a liquid test meal with a high GI over 5 minutes after baseline laboratory evaluations. The low and high GI meal contain similar amounts of milk, oil, dried egg whites, equal, and vanilla extract. The high GI meal contains corn-syrup as a carbohydrate. Both meals have similar macronutrient composition (60% carbohydrate, 15% protein, 25% fat), micronutrient profiles, physical properties, palatability and sweetness. The high vs. low GI meals have a predicted difference in GI of 90 vs. 40, and consistent with this prediction, a pilot study in obese young adults found a 2.2-fold difference in glycemic response (p<0.001). The test meals will provide 25% of individual daily energy requirements.
| Study group | Role | What they receive |
|---|---|---|
| Low GI | Active comparator | Not described Receives: Other: Low GI |
| High GI | Experimental | Not described Receives: Other: High GI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Flow in Brain Areas of Intake Control.
Measured: 4 hours postprandial
Secondary outcomes (7)
Subjective Hunger Rating
Measured: Every 30 minutes for 5 hours.
Blood Glucose Level
Measured: Every 30 minutes for 5 hours.
Blood Insulin Level
Measured: Every 30 minutes for 5 hours
Blood Glucagon Level
Measured: Every 30 minutes for 5 hours.
Blood Growth Hormone Level
Measured: Every 30 minutes for 5 hours.
Blood Epinephrine Level
Measured: Every 30 minutes for 5 hours.
Blood Fatty Acids Level
measuring metabolite profiles
Measured: Every 30 minutes for 5 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital, Brigham and Women's Hospital
- Responsible party
- Principal investigator, David Alsop, Beth Israel Deaconess Medical Center
- Investigators
- David S Ludwig, MD, PhD, Principal investigator, Boston Children's HospitalDavid Alsop, PhD, Principal investigator, Beth Israel Deaconess Medical CenterBelinda S Lennerz, MD, PhD, Study director, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064778
- Sponsor's protocol ID
- RA-003
- Status last verified
- Feb 2012
- First submitted
- 5 Feb 2010
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lennerz BS, Alsop DC, Holsen LM, Stern E, Rojas R, Ebbeling CB, Goldstein JM, Ludwig DS. Effects of dietary glycemic index on brain regions related to reward and craving in men. Am J Clin Nutr. 2013 Sep;98(3):641-7. doi: 10.3945/ajcn.113.064113. Epub 2013 Jun 26.
PubMed 23803881
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dietary Glycemic Index on Brain Function
- ClinicalTrials.gov ID
- NCT01064778
- Acronym / sponsor ID
- RA-003
- Conditions
- Obesity
- Keywords
- Glycemic Index, Brain, Intake Regulation, Weight Loss, Hunger, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Boston Children's Hospital, Brigham and Women's Hospital
- Study start
- Feb 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 8 Feb 2010 (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 investigators propose examine the effects of the dietary factor glycemic index (GI) on brain areas that control food intake and hunger. This knowledge could help design dietary approaches that decrease hunger, and thus promote new weight loss strategies.
Detailed description
Most individuals have great difficulty following reduced calorie diets because they experience increased hunger. This process is regulated by specific brain areas. Though many psychological and environmental factors are involved, physiological effects of diet may have a significant impact. The postprandial rise in blood glucose, quantified by the glycemic index (GI), is of particular interest. High GI meals elicit hormonal events that limit availability of metabolic fuels, causing hunger and overeating, especially in people with high insulin secretion.
Our aim is to examine how postprandial changes after high versus low GI meals affect hunger and brain function in areas of intake control. Specifically, we speculate that obese individuals will demonstrate functional changes in brain areas of intake control and increased hunger after a high versus low GI meal.
We will recruit obese, young adults and quantify their insulin secretion during a 2-hour oral glucose tolerance test. A brief practice MRI session will serve to familiarize the subjects with the scanning process. During the two test sessions, standardized test meals with high versus low GI will be given in a randomized, blinded cross-over design. Serial blood levels of hormones, metabolic fuels, and metabolites will be correlated with perceived hunger, and a perfusion MRI scan will be performed to assess brain activation during the late postprandial phase, at the nadir of blood sugar and insulin levels (4 hours postprandial).
This work will inform an integrated physiological model relating peripheral postprandial changes to brain function and hunger. In addition, findings may provide evidence of a novel diet-phenotype, in which baseline clinical characteristics can be used to predict which weight loss diet will work best for a specific individual. Metabolite profiling might shed light on the mechanisms linking diet composition to brain function, and provide feasible clinical markers of the identified phenotype to facilitate translation into practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low GI | Active comparator | Other: Low GI |
| High GI | Experimental | Other: High GI |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Males age 18 to 35 years
- BMI less than or equal to 25 for age and gender
Key exclusion criteria (13 listed)
- weight > 300 lbs
- largest body circumference > 144cm
- body shape incompatible with MRI scanner or equipment
- MRI exclusion criteria
- large fluctuations in body weight (5% over preceding 6 months, 2.5% during the study)
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 GISubjects will be instructed to consume a liquid test meal with a low GI over 5 minutes after baseline laboratory evaluations. The low and high GI meal contain similar amounts of milk, oil, dried egg whites, equal, and vanilla extract. The low GI meal corn-starch as a carbohydrate. Both meals have similar macronutrient composition (60% carbohydrate, 15% protein, 25% fat), micronutrient profiles, physical properties, palatability and sweetness. The high vs. low GI meals have a predicted difference in GI of 90 vs. 40, and consistent with this prediction, a pilot study in obese young adults found a 2.2-fold difference in glycemic response (p<0.001). The test meals will provide 25% of individual daily energy requirements. | Other | Low GI |
| High GISubjects will be instructed to consume a liquid test meal with a high GI over 5 minutes after baseline laboratory evaluations. The low and high GI meal contain similar amounts of milk, oil, dried egg whites, equal, and vanilla extract. The high GI meal contains corn-syrup as a carbohydrate. Both meals have similar macronutrient composition (60% carbohydrate, 15% protein, 25% fat), micronutrient profiles, physical properties, palatability and sweetness. The high vs. low GI meals have a predicted difference in GI of 90 vs. 40, and consistent with this prediction, a pilot study in obese young adults found a 2.2-fold difference in glycemic response (p<0.001). The test meals will provide 25% of individual daily energy requirements. | Other | High GI |
Primary outcome
Blood Flow in Brain Areas of Intake Control.
Time frame: 4 hours postprandial
7 secondary outcomes
Subjective Hunger Rating
Time frame: Every 30 minutes for 5 hours.
Blood Glucose Level
Time frame: Every 30 minutes for 5 hours.
Blood Insulin Level
Time frame: Every 30 minutes for 5 hours
Blood Glucagon Level
Time frame: Every 30 minutes for 5 hours.
Blood Growth Hormone Level
Time frame: Every 30 minutes for 5 hours.
Blood Epinephrine Level
Time frame: Every 30 minutes for 5 hours.
Blood Fatty Acids Level
Time frame: Every 30 minutes for 5 hours.
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 2 Feb 2012.
- Derived from this study: PubMed 23803881Lennerz BS, Alsop DC, Holsen LM, Stern E, Rojas R, Ebbeling CB, Goldstein JM, Ludwig DS. Effects of dietary glycemic index on brain regions related to reward and craving in men. Am J Clin Nutr. 2013 Sep;98(3):641-7. doi: 10.3945/ajcn.113.064113. Epub 2013 Jun 26.
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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
David Alsop, PhD principal investigator
Beth Israel Deaconess Medical Center
Belinda S Lennerz, MD, PhD study director
Boston Children's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low GI and High GI in people with Obesity, run by Beth Israel Deaconess Medical Center at 3 sites 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 2 inclusion and 13 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 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Blood Flow in Brain Areas of Intake Control. (time frame: 4 hours postprandial). 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 NCT01064778, which also lists 1 linked publication.
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 2 Feb 2012.