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Effects of Changes in Dietary Intake and Headache's Attacks

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ClinicalTrials.gov Identifier: NCT01917474
Recruitment Status : Unknown
Verified November 2014 by Ferrara Liberato Aldo, Federico II University.
Recruitment status was:  Recruiting
First Posted : August 6, 2013
Last Update Posted : November 24, 2014
Sponsor:
Information provided by (Responsible Party):
Ferrara Liberato Aldo, Federico II University

Brief 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

Condition or disease Intervention/treatment Phase
Headache Dietary Supplement: low lipid diet Dietary Supplement: normal lipid diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Changes in Dietary Intake and Headache's Attacks
Study Start Date : July 2013
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
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
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 Supplement: normal 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

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
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 Supplement: normal 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




Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients with primary headache on free diet

Exclusion Criteria:

  • Patients with laboratory or TC findings of secondary headache

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01917474


Locations
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Italy
Federico 2nd University of Naples Recruiting
Naples, Italy, 80131
Contact: Valentina Di Fronzo, MD    +39081746 ext 4712    valedifronzo@libero.it   
Headache Outpatient Clinic Dept. of Clinica Medica; Federico 2nd University of Naples Recruiting
Naples, Italy, 80131
Contact: Aldo L Ferrara, MD    +390817462302    ferrara@unina.it   
Contact: Delia Pacioni, Dietician    +390817463688    pacioni@unina.it   
Sub-Investigator: Valentina Di Fronzo, MD         
Principal Investigator: Raffaele Napoli, MD         
Sub-Investigator: Antonio Ruvolo, MD         
Sub-Investigator: Barbara Russo, MD         
Sub-Investigator: Viviana Carlino, MD         
Sub-Investigator: Francesco Gargiulo, MD         
Sub-Investigator: Patrizia Chiola, MD         
Sponsors and Collaborators
Federico II University
Investigators
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Principal Investigator: Liberato A ferrara, MD Dept. of Medicine and Surgery; Federico 2nd University of Naples
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ferrara Liberato Aldo, Associate Professor of Medicine, Federico II University
ClinicalTrials.gov Identifier: NCT01917474    
Other Study ID Numbers: 002
First Posted: August 6, 2013    Key Record Dates
Last Update Posted: November 24, 2014
Last Verified: November 2014
Keywords provided by Ferrara Liberato Aldo, Federico II University:
low-lipid diet
normal lipid intake
saturated fats reduction
headache attacks
Additional relevant MeSH terms:
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Headache
Pain
Neurologic Manifestations