MigraineNCT01859052
Diet and Migraine Study
A study testing Low carbohydrate diet, Low calorie low fat diet and AHA diet recommendations in people with Migraine and Obesity, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to look at two different diets (a low carbohydrate diet and a low fat diet) for migraine prevention in overweight or obese persons with migraine. The overall aim is to test the theory that diet will improve migraine frequency and that such improvements will be associated with favorable… Read more about this study
- Who is it for?
- Ages 19 to 49 years, women onlyHealthy volunteers can take part
- What is being tested?
- Low carbohydrate diet, Low calorie low fat diet and AHA diet recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to May 2015
- 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 19 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- overweight or obese (BMI between 25 and 42)
- women
- >18 years and < 50 years old
- Migraine meeting ICHD criteria for at least 6 months prior to screening
- headache frequency documented > 2 and < 10 headache days per month
- BP inclusion criteria are SBP <160 or DBP <100 mm Hg
Who cannot join
- hypocaloric diet (must be weight stable for prior 3 months)
- Self-report of alcohol or substance abuse in the past year or current treatment
- Type 1 or 2 diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins Bayview Headache Center
Baltimore, Maryland, 21224
About this study
The purpose of this study is to look at two different diets (a low carbohydrate diet and a low fat diet) for migraine prevention in overweight or obese persons with migraine. The overall aim is to test the theory that diet will improve migraine frequency and that such improvements will be associated with favorable changes in body weight, inflammation, and heart health.
Read the detailed description
Obesity is a risk factor for migraine. Further, in the past decade multiple lines of research have substantiated the presence of migraine headaches as a risk factor for CVD (eg. stroke). Migraineurs have also been demonstrated to have abnormal insulin responses, higher lipids and endothelial dysfunction. Limited data suggests a low fat diet may be of benefit in reducing migraine frequency; no studies have examined the efficacy of a low carbohydrate (ie. low glycemic) diet for migraine prevention in adults.. None of these studies examined the effects and potential mechanisms of such diet programs on CV health, body composition, and the inflammatory cascade in migraineurs. This 3 -month study addresses the efficacy and potential mechanisms of two different diets, (a low carbohydrate diet and a low fat diet) for migraine prevention in a clinical cohort of overweight or obese persons with migraine. The overall aim is to test the hypothesis that each behavioral intervention will improve migraine frequency and that such improvements will be associated with favorable changes in body composition, inflammation, and CV parameters.
Hypothesis 1.1 The mean monthly migraine frequency will be decreased in those who maintain a low-fat diet or low-carbohydrate diet for 3 months as compared to controls.
Hypothesis 1.2 Participants randomized to the diets will demonstrate favorable changes in body composition (eg. decrease in adipose tissue volume on magnetic resonance imaging (MRI) and body fat on DEXA), inflammatory markers (eg. decrease in adipocytokine levels), and CV parameters (eg. improved cholesterol panel, glucose levels and markers of arterial stiffness) as compared to controls.
- Being tested
- Low carbohydrate diet, Low calorie low fat diet, AHA diet recommendations
- Keywords
- migraine, obesity, low fat diet, low carbohydrate diet
- Medical subject headings
- Migraine Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low carbohydrate dietOther
Subjects will follow the Atkins for Life diet. They will be given the book and a study dietitian will guide them through the induction, ongoing weight loss, pre-maintenance, and lifetime maintenance phases.
Low calorie low fat dietOther
The diet will be a nutritionally balanced, hypocaloric diet with a deficit of 750 kcal/day as guided by TEE. The goal is to match the calorie deficit to the low-CHO diet
AHA diet recommendationsOther
given information in accordance with the diet and lifestyle recommendations of the American Heart Association.
| Study group | Role | What they receive |
|---|---|---|
| Obese migraineurs | Other | Low carbohydrate diet Receives: Other: Low carbohydrate diet; Other: Low calorie low fat diet |
| low-fat diet | Other | Obese Migraineurs Receives: Other: Low carbohydrate diet; Other: Low calorie low fat diet |
| Controls | Other | Controls receiving AHA diet recommendations Receives: Other: AHA diet recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in headache frequency
Change in headache frequency from baseline to 3 months
Measured: 3 months.
Mean change in body composition
The mean change in body composition from the baseline phase to 3 months
Measured: 3 months
The mean change in inflammatory markers
The mean change in inflammatory markers from baseline to 3 months
Measured: 3 month
Secondary outcomes (1)
Proportion of patients responding to treatment
Proportion of participants responding to weight loss program as measured by a 21% or more reduction in mean monthly migraine frequency
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startJul 2012
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: Study team was unable to effectively conduct the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Drs Barbara Peterlin, Johns Hopkins University
- Investigators
- Barbara L Peterlin, DO, Principal investigator, The Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859052
- Sponsor's protocol ID
- NIH1K23NS078345-01
- Status last verified
- Aug 2015
- First submitted
- 10 May 2013
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet and Migraine Study
- ClinicalTrials.gov ID
- NCT01859052
- Acronym / sponsor ID
- NIH1K23NS078345-01
- Keywords
- migraine, obesity, low fat diet, low carbohydrate diet
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study team was unable to effectively conduct the study.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 21 May 2013 (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 look at two different diets (a low carbohydrate diet and a low fat diet) for migraine prevention in overweight or obese persons with migraine. The overall aim is to test the theory that diet will improve migraine frequency and that such improvements will be associated with favorable changes in body weight, inflammation, and heart health.
Detailed description
Obesity is a risk factor for migraine. Further, in the past decade multiple lines of research have substantiated the presence of migraine headaches as a risk factor for CVD (eg. stroke). Migraineurs have also been demonstrated to have abnormal insulin responses, higher lipids and endothelial dysfunction. Limited data suggests a low fat diet may be of benefit in reducing migraine frequency; no studies have examined the efficacy of a low carbohydrate (ie. low glycemic) diet for migraine prevention in adults.. None of these studies examined the effects and potential mechanisms of such diet programs on CV health, body composition, and the inflammatory cascade in migraineurs. This 3 -month study addresses the efficacy and potential mechanisms of two different diets, (a low carbohydrate diet and a low fat diet) for migraine prevention in a clinical cohort of overweight or obese persons with migraine. The overall aim is to test the hypothesis that each behavioral intervention will improve migraine frequency and that such improvements will be associated with favorable changes in body composition, inflammation, and CV parameters.
Hypothesis 1.1 The mean monthly migraine frequency will be decreased in those who maintain a low-fat diet or low-carbohydrate diet for 3 months as compared to controls.
Hypothesis 1.2 Participants randomized to the diets will demonstrate favorable changes in body composition (eg. decrease in adipose tissue volume on magnetic resonance imaging (MRI) and body fat on DEXA), inflammatory markers (eg. decrease in adipocytokine levels), and CV parameters (eg. improved cholesterol panel, glucose levels and markers of arterial stiffness) as compared to controls.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obese migraineurs | Other | Other: Low carbohydrate diet, Other: Low calorie low fat dietLow carbohydrate diet |
| low-fat diet | Other | Other: Low carbohydrate diet, Other: Low calorie low fat dietObese Migraineurs |
| Controls | Other | Other: AHA diet recommendationsControls receiving AHA diet recommendations |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- overweight or obese (BMI between 25 and 42)
- women
- >18 years and < 50 years old
- Migraine meeting ICHD criteria for at least 6 months prior to screening
- headache frequency documented > 2 and < 10 headache days per month
Key exclusion criteria (3 listed)
- hypocaloric diet (must be weight stable for prior 3 months)
- Self-report of alcohol or substance abuse in the past year or current treatment
- Type 1 or 2 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 |
|---|---|---|
| Low carbohydrate dietSubjects will follow the Atkins for Life diet. They will be given the book and a study dietitian will guide them through the induction, ongoing weight loss, pre-maintenance, and lifetime maintenance phases. | Other | Obese migraineurs, low-fat diet |
| Low calorie low fat dietThe diet will be a nutritionally balanced, hypocaloric diet with a deficit of 750 kcal/day as guided by TEE. The goal is to match the calorie deficit to the low-CHO diet | Other | Obese migraineurs, low-fat diet |
| AHA diet recommendationsgiven information in accordance with the diet and lifestyle recommendations of the American Heart Association. | Other | Controls |
Primary outcome
Mean change in headache frequency
Time frame: 3 months.
Change in headache frequency from baseline to 3 months
Mean change in body composition
Time frame: 3 months
The mean change in body composition from the baseline phase to 3 months
The mean change in inflammatory markers
Time frame: 3 month
The mean change in inflammatory markers from baseline to 3 months
1 secondary outcome
Proportion of patients responding to treatment
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Study team was unable to effectively conduct the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
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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.
Barbara L Peterlin, DO principal investigator
The Johns Hopkins University
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 carbohydrate diet, Low calorie low fat diet and AHA diet recommendations in people with Migraine and Obesity, run by Johns Hopkins University 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 6 inclusion and 3 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: stopped early, as of the sponsor's last update on 2 Sep 2015. 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 was stopped early (reason given: Study team was unable to effectively conduct the study.). Results are not available in the source record.
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?
Mean change in headache frequency (time frame: 3 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2015.