Migraine HeadacheNCT03097536
Migraine and Homeostasis:What Can we Learn From Glucose
A study testing Luna Bar in people with Migraine Headache, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
Patients with migraine often report that stressors such as skipping a meal can bring on a migraine whereas some patients report that their migraine improves with food. Few studies to date have looked at the relationship between blood glucose (sugar) and migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Headache
- What is being tested?
- Luna Bar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Jan 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants, age 18-65 with episodic migraine with or without aura (ICHD-II) and/or morning onset and/or patients who self identify that eating reduces their migraine intensity.
Who cannot join
- Chronic migraine, use of hypoglycemic medication, DM I or II, abnormal finger stick glucose, obesity, comorbid eating disorders, pregnancy, seizure disorder, other serious mental or physical condition that would impair participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medial Center
Boston, Massachusetts, 02215
About this study
Patients with migraine often report that stressors such as skipping a meal can bring on a migraine whereas some patients report that their migraine improves with food. Few studies to date have looked at the relationship between blood glucose (sugar) and migraine. We are conducting this study to better understand whether or not changes in blood glucose levels can trigger migraine or provide relief during a migraine attack.
Read the detailed description
The purpose of this pilot and feasibility study is to assess if changes in blood glucose both trigger migraine and can provide analgesia. This information will provide a vital basis for the mechanism of migraine and offer insights into better treatments as well as prevention.
This is a pilot unblinded randomized trial with two independent components, Aims 1 and 2. It is not possible to blind the current protocol both in terms of the blood sugar readings and the luna bar, non-luna bar intervention.
- Conditions
- Migraine Headache
- Being tested
- Luna Bar
- Keywords
- Blood Sugar
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luna BarOther
Luna Bar (blueberry bliss or lemon zest flavor) product of Clif
| Study group | Role | What they receive |
|---|---|---|
| Luna Bar Intervention | Experimental | Participants will be asked to monitor their blood sugar during migraine. Study data will also include blood glucose levels, pain severity, 24-hour food diary, 24-hour exercise diary, duration of sleep, perception of quality of sleep, and last menstrual period. This information will be recorded at times when a Luna bar is not consumed, and at times when a Luna Bar is consumed. Participants will serve as their own controls. Receives: Other: Luna Bar |
| Morning Migraine | No intervention | Participants will be asked to monitor their blood sugar on headache free days as well as during migraine. This arm is only for participants who identify as having morning migraine. Study data will also include blood glucose levels, pain severity, 24-hour food diary, 24-hour exercise diary, duration of sleep, perception of quality of sleep, and last menstrual period. Participants will serve as their own controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in blood glucose on days with migraine compared to blood glucose on days without migraine
The primary endpoint will be the difference in blood glucose on days with migraine compared to blood glucose on days without migraine using repeated measure ANOVA
Measured: Change Measure: migraine days and non-migraine days over 3 month period.
Secondary outcomes (1)
The primary outcome is the change in pain score from the time of pain plateau to the pain score at 120 minutes as measured by a visual analogue scale.
The primary outcome is the change in pain score from the time the patients pain plateaus (as measured by having a stable pain score for 60 minutes) compared to the pain score at 120 minutes using a repeated measures ANOVA. We will compare these measures on migraine days with Luna and without Luna bar (control days) using a repeated measures ANOVA
Measured: Change Measure: migraine days and non-migraine days over 3 month period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study startMar 2016
- Primary completionJan 2025
- Study completionJan 2025
Why it stopped: COVID-19 impact
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine HeadacheStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Hovaguimian, Beth Israel Deaconess Medical Center
- Investigators
- Alexandra Hovaguimian, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097536
- Sponsor's protocol ID
- 2015P000419
- Status last verified
- Jan 2025
- First submitted
- 12 Jul 2016
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migraine and Homeostasis:What Can we Learn From Glucose
- ClinicalTrials.gov ID
- NCT03097536
- Acronym / sponsor ID
- 2015P000419
- Conditions
- Migraine Headache
- Keywords
- Blood Sugar
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 impact
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Jan 2025 (actual)
- Study completion
- Jan 2025 (actual)
- First posted
- 31 Mar 2017 (actual)
- 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.
Patients with migraine often report that stressors such as skipping a meal can bring on a migraine whereas some patients report that their migraine improves with food. Few studies to date have looked at the relationship between blood glucose (sugar) and migraine. We are conducting this study to better understand whether or not changes in blood glucose levels can trigger migraine or provide relief during a migraine attack.
Detailed description
The purpose of this pilot and feasibility study is to assess if changes in blood glucose both trigger migraine and can provide analgesia. This information will provide a vital basis for the mechanism of migraine and offer insights into better treatments as well as prevention.
This is a pilot unblinded randomized trial with two independent components, Aims 1 and 2. It is not possible to blind the current protocol both in terms of the blood sugar readings and the luna bar, non-luna bar intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Luna Bar Intervention | Experimental | Other: Luna BarParticipants will be asked to monitor their blood sugar during migraine. Study data will also include blood glucose levels, pain severity, 24-hour food diary, 24-hour exercise diary, duration of sleep, perception of quality of sleep, and last menstrual period. This information will be recorded at times when a Luna bar is not consumed, and at times when a Luna Bar is consumed. Participants will serve as their own controls. |
| Morning Migraine | No intervention | –Participants will be asked to monitor their blood sugar on headache free days as well as during migraine. This arm is only for participants who identify as having morning migraine. Study data will also include blood glucose levels, pain severity, 24-hour food diary, 24-hour exercise diary, duration of sleep, perception of quality of sleep, and last menstrual period. Participants will serve as their own controls. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female participants, age 18-65 with episodic migraine with or without aura (ICHD-II) and/or morning onset and/or patients who self identify that eating reduces their migraine intensity.
Key exclusion criteria (1 listed)
- Chronic migraine, use of hypoglycemic medication, DM I or II, abnormal finger stick glucose, obesity, comorbid eating disorders, pregnancy, seizure disorder, other serious mental or physical condition that would impair participation in 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 |
|---|---|---|
| Luna BarLuna Bar (blueberry bliss or lemon zest flavor) product of Clif | Other | Luna Bar Intervention |
Primary outcome
The difference in blood glucose on days with migraine compared to blood glucose on days without migraine
Time frame: Change Measure: migraine days and non-migraine days over 3 month period.
The primary endpoint will be the difference in blood glucose on days with migraine compared to blood glucose on days without migraine using repeated measure ANOVA
1 secondary outcome
The primary outcome is the change in pain score from the time of pain plateau to the pain score at 120 minutes as measured by a visual analogue scale.
Time frame: Change Measure: migraine days and non-migraine days over 3 month period.
Results and safety
The study was stopped early (reason given: COVID-19 impact). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Alexandra Hovaguimian, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Luna Bar in people with Migraine Headache, run by Beth Israel Deaconess Medical 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 1 inclusion and 1 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 23 Jan 2025. 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: COVID-19 impact). 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?
The difference in blood glucose on days with migraine compared to blood glucose on days without migraine (time frame: Change Measure: migraine days and non-migraine days over 3 month period.). 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 23 Jan 2025.