Effects of Changes in Dietary Intake and Headache's Attacks

NCT01917474 | Unknown DMC

• 1 other identifier: 002
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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

Conditions

Headache

Keywords

low-lipid diet; normal lipid intake; saturated fats reduction; headache attacks

Outcome Measures

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

  after 2-months of dietary treatment

Study Arms (2)

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

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.

Dietary Supplement: low lipid diet; Dietary Supplement: normal lipid diet

Interventions

low lipid diet DIETARY_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

Group A: Low-lipid diet; normal lipid diet

normal lipid diet DIETARY_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

Group A: Low-lipid diet; normal lipid diet

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with primary headache on free diet

You may not qualify if:

• Patients with laboratory or TC findings of secondary headache

Sponsors & Collaborators

• Federico II University: lead

Study Sites (2)

Federico 2nd University of Naples

Naples, 80131, Italy

RECRUITING

Headache Outpatient Clinic Dept. of Clinica Medica; Federico 2nd University of Naples

Naples, 80131, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 25698152 DERIVED

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Liberato A ferrara, MD

  Dept. of Medicine and Surgery; Federico 2nd University of Naples

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: August 6, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2016
• Last Updated: November 24, 2014

Record last verified: 2014-11

Locations

IT (2)