The Combined Effects of omega3 Fatty Acids and Curcumin Supplementation on Inflammatory and Endothelial Factors in Migraine Patients

Study Overview
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Brief Summary
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The aim of this study is to determine the effects of omega 3 fatty acid, curcumin and their combination or placebo for 2 months on the gene expression of COX-2, iNOS, TNF-α, IL-1β, IL-6, VCAM-1 and ICAM-1 in the peripheral blood mononuclear cell (PBMC) and serum levels of COX-2, iNOS, TNF-α, IL-1β, IL-6, VCAM-1, ICAM-1 and hsCRP of migraine patients.

Detailed Description
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The aim of this study is to determine the effects of omega 3 fatty acid, curcumin and their combination or placebo for 2 months on the gene expression of cyclooxygenase-2 (COX-2), inducible nitric oxide synthase (iNOS), Tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), interleukin-6 (IL-6), vascular cell adhesion molecule-1 (VCAM-1) and intercellular adhesion molecule-1 (ICAM-1) in the peripheral blood mononuclear cell (PBMC) and serum levels of COX-2, iNOS, TNF-α, IL-1β, IL-6, VCAM-1, ICAM-1 and high-sensitivity C-reactive protein (hsCRP) of migraine patients. In this randomized, double-blind clinical trial, placebo-controlled study, 80 women and men with migraine are enrolled from the Iranian Center of Neurological Research. At the start of study, all participants will sign informed consent and complete a general information form. 24-hour food recall for 3 days will be taken from the patients at the beginning and the end of the study. Selected samples by using stratified randomization method based on sex, gender and body mass index (BMI) are classified into 4 groups: 1) receiving omega 3 fatty acid supplement and curcumin supplement 2) receiving omega 3 fatty acid supplement and curcumin placebo 3) receiving curcumin supplement and omega 3 fatty acid placebo 4) receiving omega 3 fatty acid placebo and curcumin placebo. The omega 3 fatty acid supplement group will receive 1200 mg Eicosapentaenoic acid (EPA) and 600 mg Docosahexaenoic acid (DHA) totally 1800 mg daily for 2 months. The curcumin supplement group will receive 1000 mg curcumin daily for 2 months. The omega 3 fatty acid placebo group will also receive placebo containing 1800 mg edible paraffin oil and curcumin placebo group will receive 1000 mg starch powder both similar in terms of color, shape and size. participants are advised to maintain their diet, level of physical activity and medication dose during the study. Blood samples will be collected after anthropometric parameter measuring then target biochemical parameters, gene expression and serum levels and physical activity will be measured before and after the trial.

Official Title
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The Combined Effects of omega3 Fatty Acids and Curcumin Supplementation on Gene Expression and Serum Levels of Some Inflammatory and Endothelial Factors in Migraine Patients

Conditions
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Migraine

Intervention / Treatment
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* Dietary Supplement: omega 3 fatty acid
* Dietary Supplement: curcumin
* Dietary Supplement: omega 3 fatty acid placebo
* Dietary Supplement: curcumin placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: migraine patients 20- 50 years old body mass index more than 18.5 avoidance of dietary supplements, vitamins and herbal products at least 4-6 weeks before and throughout the intervention willingness to participation Exclusion Criteria: sensitivity to omega 3 fatty acid and curcumin pregnancy and lactation sever change in regular diet and life style change in type and dosage of regular medication (s) inflammatory disease which need take anti inflammatory drugs over than 2 weeks

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: omega 3 fatty acid supplementation<br>patients with migraine receive 2 capsules 1000 mg omega3, 2 times a day, for 2 months. | Dietary Supplement: omega 3 fatty acid<br>* omega 3 fatty acid supplement, 2× 1000 mg softgel daily (1800 mg EPA+DHA per day), 2 times a day, for 2 months<br>* Other names: n-3 Fatty Acid;|
| Active Comparator: curcumin supplementation<br>patients with migraine receive 2 capsules 1000 mg curcumin, 2 times a day, for 2 months. | Dietary Supplement: curcumin<br>* curcumin supplement, 2× 500 mg softgel daily (1000 mg curcumin per day), 2 times a day, for 2 months<br>|
| Placebo Comparator: omega 3 fatty acid Placebo<br>patients with migraine receive 2 capsules of omega 3 fatty acid placebo for 2 months. | Dietary Supplement: omega 3 fatty acid placebo<br>* omega 3 fatty acid placebo softgel (Containing 2 g edible paraffin oil), 2× 1000 mg softgel daily (2 g per day), 2 times a day, for 2 months<br>|
| Placebo Comparator: curcumin placebo<br>patients with migraine receive 2 capsules of curcumin placebo for 2 months. | Dietary Supplement: curcumin placebo<br>* curcumin placebo softgel (Containing 1 g starch powder), 2× 500 mg softgel daily (1 g per day), 2 times a day, for 2 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| headache attack |  | Change frome baseline at 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum COX-2 |  | Change frome baseline at 2 months | 
| serum iNOs |  | Change frome baseline at 2 months | 
| serum VCAM-1 |  | Change frome baseline at 2 months | 
| serum ICAM-1 |  | Change frome baseline at 2 months | 
| serum TNF-α |  | Change frome baseline at 2 months | 
| serum IL-1β |  | Change frome baseline at 2 months | 
| serum IL-6 |  | Change frome baseline at 2 months | 
| serum hsCRP |  | Change frome baseline at 2 months | 
| headache duration |  | Change frome baseline at 2 months | 
| headache severity |  | Change frome baseline at 2 months | 
| COX-2 gene expression |  | Change frome baseline at 2 months | 
| iNOs gene expression |  | Change frome baseline at 2 months | 
| VCAM-1 gene expression |  | Change frome baseline at 2 months | 
| ICAM-1 gene expression |  | Change frome baseline at 2 months | 
| TNF-α gene expression |  | Change frome baseline at 2 months | 
| IL-1β gene expression |  | Change frome baseline at 2 months | 
| IL-6 gene expression |  | Change frome baseline at 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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omega 3 fatty acid, curcumin, COX-2, iNOs, VCAM-1, ICAM-1, IL-1β, IL-6, TNF-α, hsCRP, migraine