MigraineNCT02703129
Nutritional Intervention in Migraine
A study testing Nutritional intervention in people with Migraine, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
Migraine is a common medical condition. Several studies suggest that obesity and/or weight gain are risk factors for aggravating migraine course, especially increase the frequency of headache episodes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Migraine
- What is being tested?
- Nutritional intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2010to Dec 2012
- 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 Any age
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women;
- Older than 18 years;
- Migraine diagnosis;
- Agree to sign the informed consent.
Who cannot join
- Patients with headaches not characterized as migraine;
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Intervention Fin Migraine: A 12-week Open Study
Migraine is a common medical condition. Several studies suggest that obesity and/or weight gain are risk factors for aggravating migraine course, especially increase the frequency of headache episodes. The aim of the current study was to evaluate whether nutritional intervention would be able to improve clinical parameters (as assessed by MIDAS and HIT) of patients with migraine.
Read the detailed description
Women with the diagnosis of migraine according to the International Headache Society (IHS-2) criteria received individualized diet meal plan and nutritional orientation for 12 weeks according to their nutritional diagnosis. Patients were evaluated three times with an interval of 30 days between each visit. Clinical, anthropometric measurements (weight, height, waist circumference and body composition assessed by bioelectrical impedance analysis) and food evaluations were performed. Nutritional orientations were strengthened in each visit. The diet prescription did not change during intervention period. The diet quality of the patients was assessed through the Brazilian Healthy Eating Index - Revised (BHEI-R) version. Migraine severity was assessed with the Headache Impact Test (HIT) and the Migraine Disability Assessment Scale (MIDAS). Depressive symptoms were also evaluated with the Beck Depression Inventory (BDI).
- Conditions
- Migraine
- Being tested
- Nutritional intervention
- Keywords
- Migraine, Diet quality, Nutritional intervention, Severity of disease, Depressive symptoms
- Medical subject headings
- Migraine Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional interventionOther
Women with the diagnosis of migraine received individualized diet meal plan and nutritional orientations for three months according to their nutritional diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Nutritional intervention | Experimental | Women with the diagnosis of migraine received individualized diet meal plan and nutritional orientations for three months according to their nutritional diagnosis Receives: Other: Nutritional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinical parameters of migraine patients by nutritional intervention in the last month.
Migraine impact/severity in the last month was assessed by HIT-6.
Measured: 4 weeks
Change in clinical parameters of migraine patients by nutritional intervention in the last three month.
Migraine impact/severity in the last three month was assessed by MIDAS.
Measured: 12 weeks
Secondary outcomes (2)
Change in diet quality of migraine patients by nutritional intervention assessed with the Brazilian Healthy Eating Index - Revised (BHEI-R)
Diet quality was assessed through the Brazilian Healthy Eating Index - Revised (BHEI-R)
Measured: 12 weeks
Change in depressive symptoms in migraine patients by nutritional intervention assessed with the Beck Depression Inventory (BDI)
Depressive symptoms were assessed by the Beck Depression Inventory (BDI)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startJan 2010
- Primary completionDec 2012
- Study completionDec 2012
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio L Teixeira Jr, Federal University of Minas Gerais
- Investigators
- Adaliene VM Ferreira, PhD, Study director, Federal University of Minas GeraisAline Bárbara P Costa, Ms, Study chair, Federal University of Minas GeraisAntônio L Teixeira, PhD, Principal investigator, Federal University of Minas GeraisLaís B Martins, Ms, Study chair, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703129
- Sponsor's protocol ID
- CAAE 0311.0.203.000-11
- Status last verified
- Mar 2016
- First submitted
- 5 Feb 2016
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Intervention Fin Migraine: A 12-week Open Study
- ClinicalTrials.gov ID
- NCT02703129
- Acronym / sponsor ID
- CAAE 0311.0.203.000-11
- Conditions
- Migraine
- Keywords
- Migraine, Diet quality, Nutritional intervention, Severity of disease, Depressive symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 Mar 2016 (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.
Migraine is a common medical condition. Several studies suggest that obesity and/or weight gain are risk factors for aggravating migraine course, especially increase the frequency of headache episodes. The aim of the current study was to evaluate whether nutritional intervention would be able to improve clinical parameters (as assessed by MIDAS and HIT) of patients with migraine.
Detailed description
Women with the diagnosis of migraine according to the International Headache Society (IHS-2) criteria received individualized diet meal plan and nutritional orientation for 12 weeks according to their nutritional diagnosis. Patients were evaluated three times with an interval of 30 days between each visit. Clinical, anthropometric measurements (weight, height, waist circumference and body composition assessed by bioelectrical impedance analysis) and food evaluations were performed. Nutritional orientations were strengthened in each visit. The diet prescription did not change during intervention period. The diet quality of the patients was assessed through the Brazilian Healthy Eating Index - Revised (BHEI-R) version. Migraine severity was assessed with the Headache Impact Test (HIT) and the Migraine Disability Assessment Scale (MIDAS). Depressive symptoms were also evaluated with the Beck Depression Inventory (BDI).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutritional intervention | Experimental | Other: Nutritional interventionWomen with the diagnosis of migraine received individualized diet meal plan and nutritional orientations for three months according to their nutritional diagnosis |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Women;
- Older than 18 years;
- Migraine diagnosis;
- Agree to sign the informed consent.
Key exclusion criteria (2 listed)
- Patients with headaches not characterized as migraine;
- Pregnant or lactating women.
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 |
|---|---|---|
| Nutritional interventionWomen with the diagnosis of migraine received individualized diet meal plan and nutritional orientations for three months according to their nutritional diagnosis | Other | Nutritional intervention |
Primary outcome
Change in clinical parameters of migraine patients by nutritional intervention in the last month.
Time frame: 4 weeks
Migraine impact/severity in the last month was assessed by HIT-6.
Change in clinical parameters of migraine patients by nutritional intervention in the last three month.
Time frame: 12 weeks
Migraine impact/severity in the last three month was assessed by MIDAS.
2 secondary outcomes
Change in diet quality of migraine patients by nutritional intervention assessed with the Brazilian Healthy Eating Index - Revised (BHEI-R)
Time frame: 12 weeks
Change in depressive symptoms in migraine patients by nutritional intervention assessed with the Beck Depression Inventory (BDI)
Time frame: 12 weeks
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 9 Mar 2016.
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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.
Adaliene VM Ferreira, PhD study director
Federal University of Minas Gerais
Aline Bárbara P Costa, Ms study chair
Federal University of Minas Gerais
Antônio L Teixeira, PhD principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional intervention in people with Migraine, run by Federal University of Minas Gerais at 1 site in Brazil.
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 4 inclusion and 2 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 9 Mar 2016. 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 Brazil. 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 clinical parameters of migraine patients by nutritional intervention in the last month. (time frame: 4 weeks). The study lists 2 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 9 Mar 2016.