HeadacheNCT01917474
Effects of Changes in Dietary Intake and Headache's Attacks
A study testing low lipid diet and normal lipid diet in people with Headache, run by Federico II University at 2 sites in Italy.
Trial summary
Headache is a frequently disabling disorder, which occurs in about 30% of the adult population, particularly in overweight/obese women. Aim of the study is to modify the nutritional habits of the patients and to evaluate the effects of a low lipid intake vs. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Headache
- What is being tested?
- low lipid diet and normal lipid diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesItaly
- Study dates
- Jul 2013to Oct 2016
- 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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with primary headache on free diet
Who cannot join
- Patients with laboratory or TC findings of secondary headache
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Federico 2nd University of Naples
Naples, 80131
Valentina Di Fronzo, MD, +39081746 ext. 4712, valedifronzo@libero.it
- Recruiting
Headache Outpatient Clinic Dept. of Clinica Medica; Federico 2nd University of Naples
Naples, 80131
Aldo L Ferrara, MD, +390817462302, ferrara@unina.it
Delia Pacioni, Dietician, +390817463688, pacioni@unina.it
About this study
Headache is a frequently disabling disorder, which occurs in about 30% of the adult population, particularly in overweight/obese women. Aim of the study is to modify the nutritional habits of the patients and to evaluate the effects of a low lipid intake vs. a normal lipid diet on the incidence and severity of migraine crises. Moreover vascular reactivity will be evaluated in a randomly selected subgroup of patients. This randomized, cross-over intervention trial will be performed in about 150 patients, affected by migraine. Adherence to the diet, particularly regarding energy intake, percent of energy from lipids, carbohydrates and proteins will be carefully assessed at baseline and during the 2 intervention periods
Read the detailed description
Headache is a common disease in general population, which affects adult women more frequently than men. Among different factors which might be involved in the pathophysiology of the disease, eating or drinking a particular food or drink have been shown to act as a trigger of acute attacks. In particular foods such as aged cheese or red wine may trigger acute migraine attacks and dietary habits such as excessive caffeine intake may increase headache frequency.
Moreover a close relationship has been detected between overweight/obesity and migraine severity even if other authors showed that obesity at baseline does not seem to be related to follow-up refractoriness to preventive treatment.
At the first visit, patients will undergo a complete clinical examination and body weight (BW), height (HT), blood pressure (SBP/DBP) and heart rate (HR) will be also measured. Body mass index (BMI) will be calculated as BW/HT2 and expressed in kg/m2. We consider overweight patients with BMI> 25 and < 30 whilst frankly obese are those with BMI > 30. Patients will be followed-up for two months when treatment for the prevention of headache (usually the calcium entry blocker flunarizine 5 mg/day) will be added to the habitual dietary regimen. At the end of this run-in period all patients will be randomly attributed to one of the following two dietary regimens: a low lipid diet with a lipid content < 20% of the total daily energy intake and a normal lipid diet with a lipid intake between 25-30% of the total daily energy intake. In both diet lipid intake is mostly represented by monounsaturated fatty acids (14% in the low lipid and 19% in the normal lipid diet) with a low intake of saturated fats (< 8%of the total calories, which is the percentage usually recommend in our diets). Patients will be followed-up for 2 months at the end of which they will be switched to the alternative dietary regimen.
At baseline and during the observation period patients will be seen at the Headache Outpatient Clinic of our department at one month intervals. At each visit they will be given a form to be filled at home, summarizing the number of the monthly headache attacks, the severity of each one graded from 0.1 to 3 from mild to severe pain, and how many times they assumed pills for the therapy of the attacks during the last month. Headache attacks with severe pain will be considered those receiving a score > 2.5. Moreover, at each visit patients will fill-up a food questionnaire, validated in comparison to the 7-day food record (12), with the help of a well trained dietician. Data are expressed as daily percent caloric intake from each macronutrient and as the weekly number of a medium size serving.
Main drugs suggested for the pain relief at each attack are the selective serotonin receptor agonists (triptans), which are abortive migraine medications, and the non steroidal anti-inflammatory agents.
In a randomly selected subgroup of patients we will evaluate at baseline and after diet:
- Vascular dysfunction by echography at the brachial artery level after ischaemia (Flow mediated dilatation) and after nitroglycerin 0.3 mg;
- Intimal-media thickness at carotid artery level will be evaluated by b-mode echography;
- central pressure and pulse wave velocity by tonometry applanation.
- Conditions
- Headache
- Being tested
- low lipid diet, normal lipid diet
- Keywords
- low-lipid diet, normal lipid intake, saturated fats reduction, headache attacks
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low lipid dietDietary supplement
Patients will receive a diet of about 2000 kcal daily with no more than 20 % of the total energy coming from lipids, mainly from the monounsaturated olive oil
normal lipid dietDietary supplement
Patients will receive a diet of about 2000 kcal daily with 28 % of the total energy coming from lipids, mainly from the monounsaturated olive oil
| Study group | Role | What they receive |
|---|---|---|
| Group A: Low-lipid diet | Experimental | Lifestyle counseling At the end of this run-in period all patients will be randomly attributed to one of the following two dietary regimens. Those in the experimental groupwill be given a low lipid diet with a lipid content < 20% of the total daily energy intake with the following composition:
Proteins (g) 77 (15% total energy intake) Lipids (g) 48 (22% total energy intake) Saturated (g) 9 (4% total energy intake) Monounsaturated (g) 31 (14% total energy intake) Polyunsaturated (g) 8 (4% total energy intake) Carbohydrates (g) 330 (63% total energy intake) Cholesterol (mg) 117 Fibres (g) 32 Total Energy (kcal) 1977 Receives: Dietary Supplement: low lipid diet; Dietary Supplement: normal lipid diet |
| normal lipid diet | Active comparator | Patients in the active comparator will be given a diet with normal lipid intake and the following composition:
Proteins (g) 75 (15% total energy intake) Lipids (g) 67 (29% total energy intake) Saturated (g) 14 (6% total energy intake) Monounsaturated (g) 43 (19% total energy intake) Polyunsaturated (g) 10 (4% total energy intake) Carbohydrates (g) 307 (56% total energy intake) Cholesterol (mg) 128 Fibres (g) 32 Total Energy (kcal) 2048 lipid intake between 25-30% of the total daily energy intake. Receives: Dietary Supplement: low lipid diet; Dietary Supplement: normal lipid diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
To verify the possibility that low-lipid diet might reduce of the half the number and intensity of headache attacks.It will be considered efficacy if will be a reduction of 50% of headheach crisis after two months of dietetic low lipid treatment
Measured: after 2-months of dietary treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2015 (estimated)
- Study completionOct 2016 (estimated)
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 HeadacheStudies of the same condition, open and under way.
- More trials run by Federico II 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferrara Liberato Aldo, Federico II University
- Investigators
- Liberato A ferrara, MD, Principal investigator, Dept. of Medicine and Surgery; Federico 2nd University of Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917474
- Sponsor's protocol ID
- 002
- Status last verified
- Nov 2014
- First submitted
- 30 Jul 2013
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ferrara LA, Pacioni D, Di Fronzo V, Russo BF, Speranza E, Carlino V, Gargiulo F, Ferrara F. Low-lipid diet reduces frequency and severity of acute migraine attacks. Nutr Metab Cardiovasc Dis. 2015 Apr;25(4):370-5. doi: 10.1016/j.numecd.2014.12.006. Epub 2014 Dec 27.
PubMed 25698152
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Changes in Dietary Intake and Headache's Attacks
- ClinicalTrials.gov ID
- NCT01917474
- Acronym / sponsor ID
- 002
- Conditions
- Headache
- Keywords
- low-lipid diet, normal lipid intake, saturated fats reduction, headache attacks
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 6 Aug 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.
Headache is a frequently disabling disorder, which occurs in about 30% of the adult population, particularly in overweight/obese women. Aim of the study is to modify the nutritional habits of the patients and to evaluate the effects of a low lipid intake vs. a normal lipid diet on the incidence and severity of migraine crises. Moreover vascular reactivity will be evaluated in a randomly selected subgroup of patients. This randomized, cross-over intervention trial will be performed in about 150 patients, affected by migraine. Adherence to the diet, particularly regarding energy intake, percent of energy from lipids, carbohydrates and proteins will be carefully assessed at baseline and during the 2 intervention periods
Detailed description
Headache is a common disease in general population, which affects adult women more frequently than men. Among different factors which might be involved in the pathophysiology of the disease, eating or drinking a particular food or drink have been shown to act as a trigger of acute attacks. In particular foods such as aged cheese or red wine may trigger acute migraine attacks and dietary habits such as excessive caffeine intake may increase headache frequency.
Moreover a close relationship has been detected between overweight/obesity and migraine severity even if other authors showed that obesity at baseline does not seem to be related to follow-up refractoriness to preventive treatment.
At the first visit, patients will undergo a complete clinical examination and body weight (BW), height (HT), blood pressure (SBP/DBP) and heart rate (HR) will be also measured. Body mass index (BMI) will be calculated as BW/HT2 and expressed in kg/m2. We consider overweight patients with BMI> 25 and < 30 whilst frankly obese are those with BMI > 30. Patients will be followed-up for two months when treatment for the prevention of headache (usually the calcium entry blocker flunarizine 5 mg/day) will be added to the habitual dietary regimen. At the end of this run-in period all patients will be randomly attributed to one of the following two dietary regimens: a low lipid diet with a lipid content < 20% of the total daily energy intake and a normal lipid diet with a lipid intake between 25-30% of the total daily energy intake. In both diet lipid intake is mostly represented by monounsaturated fatty acids (14% in the low lipid and 19% in the normal lipid diet) with a low intake of saturated fats (< 8%of the total calories, which is the percentage usually recommend in our diets). Patients will be followed-up for 2 months at the end of which they will be switched to the alternative dietary regimen.
At baseline and during the observation period patients will be seen at the Headache Outpatient Clinic of our department at one month intervals. At each visit they will be given a form to be filled at home, summarizing the number of the monthly headache attacks, the severity of each one graded from 0.1 to 3 from mild to severe pain, and how many times they assumed pills for the therapy of the attacks during the last month. Headache attacks with severe pain will be considered those receiving a score > 2.5. Moreover, at each visit patients will fill-up a food questionnaire, validated in comparison to the 7-day food record (12), with the help of a well trained dietician. Data are expressed as daily percent caloric intake from each macronutrient and as the weekly number of a medium size serving.
Main drugs suggested for the pain relief at each attack are the selective serotonin receptor agonists (triptans), which are abortive migraine medications, and the non steroidal anti-inflammatory agents.
In a randomly selected subgroup of patients we will evaluate at baseline and after diet:
- Vascular dysfunction by echography at the brachial artery level after ischaemia (Flow mediated dilatation) and after nitroglycerin 0.3 mg;
- Intimal-media thickness at carotid artery level will be evaluated by b-mode echography;
- central pressure and pulse wave velocity by tonometry applanation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Low-lipid diet | Experimental | Dietary Supplement: low lipid diet, Dietary Supplement: normal lipid dietLifestyle counseling At the end of this run-in period all patients will be randomly attributed to one of the following two dietary regimens. Those in the experimental groupwill be given a low lipid diet with a lipid content < 20% of the total daily energy intake with the following composition: Proteins (g) 77 (15% total energy intake) Lipids (g) 48 (22% total energy intake) Saturated (g) 9 (4% total energy intake) Monounsaturated (g) 31 (14% total energy intake) Polyunsaturated (g) 8 (4% total energy intake) Carbohydrates (g) 330 (63% total energy intake) Cholesterol (mg) 117 Fibres (g) 32 Total Energy (kcal) 1977 |
| normal lipid diet | Active comparator | Dietary Supplement: low lipid diet, Dietary Supplement: normal lipid dietPatients in the active comparator will be given a diet with normal lipid intake and the following composition: Proteins (g) 75 (15% total energy intake) Lipids (g) 67 (29% total energy intake) Saturated (g) 14 (6% total energy intake) Monounsaturated (g) 43 (19% total energy intake) Polyunsaturated (g) 10 (4% total energy intake) Carbohydrates (g) 307 (56% total energy intake) Cholesterol (mg) 128 Fibres (g) 32 Total Energy (kcal) 2048 lipid intake between 25-30% of the total daily energy intake. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with primary headache on free diet
Key exclusion criteria (1 listed)
- Patients with laboratory or TC findings of secondary headache
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 lipid dietPatients will receive a diet of about 2000 kcal daily with no more than 20 % of the total energy coming from lipids, mainly from the monounsaturated olive oil | Dietary supplement | Group A: Low-lipid diet, normal lipid diet |
| normal lipid dietPatients will receive a diet of about 2000 kcal daily with 28 % of the total energy coming from lipids, mainly from the monounsaturated olive oil | Dietary supplement | Group A: Low-lipid diet, normal lipid diet |
Primary outcome
To verify the possibility that low-lipid diet might reduce of the half the number and intensity of headache attacks.It will be considered efficacy if will be a reduction of 50% of headheach crisis after two months of dietetic low lipid treatment
Time frame: after 2-months of dietary treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
- Derived from this study: PubMed 25698152Ferrara LA, Pacioni D, Di Fronzo V, Russo BF, Speranza E, Carlino V, Gargiulo F, Ferrara F. Low-lipid diet reduces frequency and severity of acute migraine attacks. Nutr Metab Cardiovasc Dis. 2015 Apr;25(4):370-5. doi: 10.1016/j.numecd.2014.12.006. Epub 2014 Dec 27.
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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.
Headache Outpatient Clinic Dept. of Clinica Medica; Federico 2nd University of Naples
Naples, Italy
Liberato A ferrara, MD principal investigator
Dept. of Medicine and Surgery; Federico 2nd University of Naples
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low lipid diet and normal lipid diet in people with Headache, run by Federico II University at 2 sites in Italy.
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: status not confirmed, as of the sponsor's last update on 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To verify the possibility that low-lipid diet might reduce of the half the number and intensity of headache attacks.It will be considered efficacy if will be a reduction of 50% of headheach crisis after two months of dietetic low lipid treatment (time frame: after 2-months of dietary treatment). 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 NCT01917474, 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 24 Nov 2014.