Nutrition for Migraine Prevention
Λέξεις-κλειδιά
Αφηρημένη
Περιγραφή
Episodic migraine is a debilitating chronic pain condition afflicting 12% of American adults. Current conventional treatments rely on medications that provide limited or transient relief, target symptoms rather than the underlying causes of pain, and are associated with significant side effects and costs. It is therefore essential to investigate non-pharmacologic approaches to conventional headache treatments. Certain fatty acids and their bioactive metabolites regulate multiple pain-related biochemical pathways. Controlled clinical trials investigating pain modulation in response to dietary changes while exploring relevant mechanisms of action in humans are lacking.
In a recent feasibility study in patients with chronic daily headache (CDH), we found that targeted fatty acid modifications altered circulating endovanilloids, while reducing headache frequency and improving quality of life. These findings support our proposed model in which diet-induced alterations in endovanilloids modulate transient receptor potential cation channel subfamily V member 1 (TRPV1) activity in vivo, leading to important implications for migraine and chronic pain in general.
The goal of this research is to assess whether dietary PUFA modifications can result in predicted changes in circulating endovanilloids and improvement in headache-related clinical outcomes. The proposed 3-arm, 26-week,randomized, controlled, single-blind trial, with 51 subjects in each group, includes a 4-week baseline of usual care, followed by randomization to one of three 22-week dietary interventions plus usual care. Each of the three arms involves specific modifications of dietary fatty acid intakes through a whole foods diet. Participants in the dietary interventions receive food sufficient for 2 meals and 2 snacks daily along with extensive dietary counseling.
Specific aims are:
1. To assess the efficacy of the dietary interventions in inducing the predicted changes in circulating fatty acid endovanilloid derivatives;
2. To compare the clinical effects in migraine specific outcomes of two 16-week analgesic dietary interventions with each other and a control diet;
3. To test, in an exploratory manner, our model of the proposed causal chain linking changes in fatty acids, their endovanilloid derivatives, and headache clinical endpoints.
This proposal utilizes an innovative design and hypotheses to address current research funding priorities, by examining clinical efficacy and underlying mechanisms of a promising dietary manipulation with the distinct potential for high impact in terms of ameliorating a chronic, disabling pain disorder.
Ημερομηνίες
| Τελευταία επαλήθευση: | 05/31/2018 |
| Πρώτα υποβλήθηκε: | 11/04/2013 |
| Υποβλήθηκε εκτιμώμενη εγγραφή: | 12/09/2013 |
| Δημοσιεύτηκε για πρώτη φορά: | 12/15/2013 |
| Υποβλήθηκε τελευταία ενημέρωση: | 06/27/2018 |
| Δημοσιεύτηκε η τελευταία ενημέρωση: | 06/28/2018 |
| Ημερομηνία έναρξης της πραγματικής μελέτης: | 06/30/2014 |
| Εκτιμώμενη κύρια ημερομηνία ολοκλήρωσης: | 03/28/2018 |
| Εκτιμώμενη ημερομηνία ολοκλήρωσης μελέτης: | 05/10/2018 |
Κατάσταση ή ασθένεια
Παρέμβαση / θεραπεία
Other: Diet
Φάση
Ομάδες βραχιόνων
| Μπράτσο | Παρέμβαση / θεραπεία |
|---|---|
| Experimental: Diet A Whole food diet modifies dietary fatty acids. Foods provided for 16 weeks; study oils provided for 22 weeks. | |
| Experimental: Diet B Whole food diet modifies dietary fatty acids. Foods provided for 16 weeks; study oils provided for 22 weeks. | |
| Active Comparator: Diet C Whole food diet modifies dietary fatty acids. Foods provided for 16 weeks; study oils provided for 22 weeks. |
Κριτήρια καταλληλότητας
| Επιλέξιμες ηλικίες για μελέτη | 18 Years Προς την 18 Years |
| Φύλα επιλέξιμα για μελέτη | All |
| Δέχεται υγιείς εθελοντές | Ναί |
| Κριτήρια | Inclusion Criteria: - 18 years of age or older - Either gender - Meets 2004 International Classification of Headache Disorders-II* criteria for Episodic Migraine - Frequent migraine headaches - Headache history: > 2 years leading up to study meeting migraine criteria - Willing to complete daily diary for 26 weeks - Able to attend 8 dietitian counseling sessions - Under care of a physician for headaches - Able to read and communicate in English Exclusion Criteria: - Marked depression, anxiety or psychosis. - History of specific food allergies, such as, but not limited to, dairy or gluten products - Pregnancy or anticipated pregnancy - Active treatment for a major medical illness, such as malignancy, autoimmune, immune deficiency disorder, etc. - History of significant head trauma or head/neck surgery within the past 3 years - History of subarachnoid or intra-cerebral hemorrhage or subdural hematoma - Allergy to fish or strong aversion to fish consumption. - History of nervous system infection such as meningitis or encephalitis within the preceding 5 years - History of vasculitis, intracranial mass, clotting disorder - Cognitive dysfunction that would prevent informed consent |
Αποτέλεσμα
Πρωτεύοντα αποτελέσματα
1. Primary metabolic outcome: 17-hydroxy docosahexaenoic acid (DHA) [Change in 17-hydroxy DHA at 16 weeks]
2. Primary clinical outcome: Headache-specific Quality of Life (HIT-6) [Change in HIT-6 at 16 weeks]
Δευτερεύοντα αποτελέσματα
1. Headache hours per day (headache frequency) are measured by a daily Headache Diary [Trajectory of change: -4 to 0 weeks (pre-intervention), 0-16 weeks (intervention), and 16-22 weeks (post-intervention)]
2. Patient-Reported Outcomes Measurement Information System-29 Profile [Pre-post and trajectory of change measured at randomization and at 4,10, and 16 weeks after randomization]
3. 17-hydroxy DHA trajectory [Trajectory of change in 17-hydroxy DHA 0-16 weeks and 16-22 weeks]
4. HIT-6 [Trajectory of change pre-intervention, 0-16 weeks, and 16-22 weeks]
Άλλα μέτρα αποτελεσμάτων
1. Migraine Disability Assessment Score (MIDAS) [Change in MIDAS from randomization to 16 weeks after randomization]
2. Medication use for treatment of headache. [trajectory of change over 16 weeks]
3. Unusual symptoms [Daily for 4 weeks before randomization, and 22 weeks after randomization]
