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Status unknownNCT01917474Updated Nov 24, 2014

Effects of Changes in Dietary Intake and Headache's Attacks

An interventional study of low lipid diet and normal lipid diet in Headache, sponsored by Federico II University. Status unknown at 2 sites in Italy. Open to participants aged Up to 75 Years. Per ClinicalTrials.gov, last updated 2014-11-24.

Sponsored by Federico II University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
Up to 75 Years
Sex
All
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Study 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. 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:

  1. Vascular dysfunction by echography at the brachial artery level after ischaemia (Flow mediated dilatation) and after nitroglycerin 0.3 mg;
  2. Intimal-media thickness at carotid artery level will be evaluated by b-mode echography;
  3. central pressure and pulse wave velocity by tonometry applanation.
02

Conditions studied

  • Headache

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Keywords

  • low-lipid diet
  • normal lipid intake
  • saturated fats reduction
  • headache attacks
03

In context

Headache

1,226 studies on the registry are indexed under Headache; 203 are open to participants now.

This study's planned enrollment of 150 is above the median of 60 across 919 interventional studies indexed under Headache.

Browse Headache studies →

Lead sponsor

Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All patients with primary headache on free diet

Exclusion criteria

Exclusion Criteria:

  • Patients with laboratory or TC findings of secondary headache
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Group A: Low-lipid diet

    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

    Dietary Supplement: low lipid diet · Dietary Supplement: normal lipid diet

  • Active comparator
    normal lipid diet

    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.

    Dietary Supplement: low lipid diet · Dietary Supplement: normal lipid diet

Interventions

  • Dietary supplementlow lipid diet

    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

  • Dietary supplementnormal lipid diet

    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

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What researchers measure

Primary outcomes

  1. 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

07

Study locations

2 of 2 sites recruiting
  • Federico 2nd University of Naples
    Naples, 80131, Italy
    Recruiting
  • Headache Outpatient Clinic Dept. of Clinica Medica; Federico 2nd University of Naples
    Naples, 80131, Italy
    • Aldo L Ferrara, MD · Contact · ferrara@unina.it · +390817462302
    • Delia Pacioni, Dietician · Contact · pacioni@unina.it · +390817463688
    • Valentina Di Fronzo, MD · Sub investigator
    • Raffaele Napoli, MD · Principal investigator
    • Antonio Ruvolo, MD · Sub investigator
    • Barbara Russo, MD · Sub investigator
    • Viviana Carlino, MD · Sub investigator
    • Francesco Gargiulo, MD · Sub investigator
    • Patrizia Chiola, MD · Sub investigator
    Recruiting
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01917474
Lead sponsor
Federico II University
Responsible party
Ferrara Liberato Aldo (Associate Professor of Medicine, Federico II University) — Principal investigator
First posted
Aug 6, 2013
Start date
Jul 2013
Primary completion
Oct 2015 (estimated)
Completion
Oct 2016 (estimated)
Last update
Nov 24, 2014

Study contacts

Liberato A ferrara, MD
principal investigator · Dept. of Medicine and Surgery; Federico 2nd University of Naples

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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