- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01917474
Effects of Changes in Dietary Intake and Headache's Attacks
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Naples, Italy, 80131
- Recruiting
- Federico 2nd University of Naples
-
Contact:
- Valentina Di Fronzo, MD
- Phone Number: 4712 +39081746
- Email: valedifronzo@libero.it
-
Naples, Italy, 80131
- Recruiting
- Headache Outpatient Clinic Dept. of Clinica Medica; Federico 2nd University of Naples
-
Contact:
- Aldo L Ferrara, MD
- Phone Number: +390817462302
- Email: ferrara@unina.it
-
Contact:
- Delia Pacioni, Dietician
- Phone Number: +390817463688
- Email: pacioni@unina.it
-
Sub-Investigator:
- Valentina Di Fronzo, MD
-
Sub-Investigator:
- Barbara Russo, MD
-
Sub-Investigator:
- Viviana Carlino, MD
-
Sub-Investigator:
- Francesco Gargiulo, MD
-
Principal Investigator:
- Raffaele Napoli, MD
-
Sub-Investigator:
- Antonio Ruvolo, MD
-
Sub-Investigator:
- Patrizia Chiola, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients with primary headache on free diet
Exclusion Criteria:
- Patients with laboratory or TC findings of secondary headache
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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 |
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
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. |
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
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
after 2-months of dietary treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Liberato A ferrara, MD, Dept. of Medicine and Surgery; Federico 2nd University of Naples
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 002 (University of CT Health Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Headache
-
Canadian Memorial Chiropractic CollegeDr. Zaxx Co.UnknownMigraine Headache | Cervicogenic Headache | Tension-type HeadacheCanada
-
University GhentRecruitingTension-Type Headache | Cervicogenic Headache | Myofascial HeadacheBelgium
-
Real Centro Universitario Maria CristinaRecruiting
-
Brooke Army Medical CenterThe University of Queensland; The Defense and Veterans Brain Injury CenterRecruitingHeadache, Migraine | Persistent Post Traumatic Headache | Cervicogenic HeadacheUnited States
-
Uniformed Services University of the Health SciencesNational Institutes of Health (NIH); University of North Carolina, Chapel Hill and other collaboratorsRecruitingPost-Traumatic Headache Chronic Without Intractable HeadacheUnited States
-
University of WashingtonTerminatedChronic Post Traumatic HeadacheUnited States
-
University of AlbertaCompletedChronic Headache | Chronic Daily Headache | Analgesic Rebound Headache | Headache, IntractableCanada
-
University Hospital, GhentRecruitingMigraine Disorders | Headache Disorders | Tension-Type Headache | Cluster Headache | TACS | Secondary Headache DisorderBelgium
-
Meltem UzunCompletedExercise | Therapeutics | Headache, CervicogenicTurkey
-
Hospital of South West JutlandCompletedMedication-overuse Headache | Secondary Headache Disorders
Clinical Trials on low lipid diet
-
Federico II UniversityUnknownHypertension | Body WeightItaly
-
Burke Rehabilitation HospitalCompletedStroke | Ischemic StrokeUnited States
-
Cedars-Sinai Medical CenterRecruitingImplementing a Low Fiber Diet vs. Regular Diet in Postoperative Colorectal Patients With IleostomiesIleostomy; Complications | Bowel Obstruction | Postoperative IleusUnited States
-
Queen's UniversityTerminatedObesity | Cardiovascular Disease | Metabolic SyndromeCanada
-
Boston Children's HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Brigham...Completed
-
Region StockholmRecruitingDiabetes Mellitus Type 2 in ObeseSweden
-
Albert Einstein College of MedicineRobert C. Atkins FoundationCompletedType 2 DiabetesUnited States
-
Tulane University Health Sciences CenterCompletedCardiovascular Diseases | Obesity | Body Composition | Blood PressureUnited States
-
Vårdcentralen LyckornaCompletedType 2 Diabetes MellitusSweden