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

Tehran University of Medical Sciences

Status and phase: Unknown; Phase 4

Conditions: Migraine

Treatments: Dietary Supplement: omega 3 fatty acid; Dietary Supplement: curcumin placebo; Dietary Supplement: omega 3 fatty acid placebo; Dietary Supplement: curcumin

Study type: Interventional

Funder types: Other

Identifiers

NCT02532023

28825

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups, including a placebo group

omega 3 fatty acid supplementation

Active Comparator group

Description:

patients with migraine receive 2 capsules 1000 mg omega3, 2 times a day, for 2 months.

Treatment:

Dietary Supplement: omega 3 fatty acid

curcumin supplementation

Active Comparator group

Description:

patients with migraine receive 2 capsules 1000 mg curcumin, 2 times a day, for 2 months.

Treatment:

Dietary Supplement: curcumin

omega 3 fatty acid Placebo

Placebo Comparator group

Description:

patients with migraine receive 2 capsules of omega 3 fatty acid placebo for 2 months.

Treatment:

Dietary Supplement: omega 3 fatty acid placebo

curcumin placebo

Placebo Comparator group

Description:

patients with migraine receive 2 capsules of curcumin placebo for 2 months.

Treatment:

Dietary Supplement: curcumin placebo