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

NCT ID: NCT02532023

Last Updated: 2015-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-02-28

Brief Summary

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

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.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

omega 3 fatty acid supplementation

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

Group Type: ACTIVE_COMPARATOR

omega 3 fatty acid

Intervention Type: DIETARY_SUPPLEMENT

omega 3 fatty acid supplement, 2× 1000 mg softgel daily (1800 mg EPA+DHA per day), 2 times a day, for 2 months

curcumin supplementation

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

Group Type: ACTIVE_COMPARATOR

curcumin

Intervention Type: DIETARY_SUPPLEMENT

curcumin supplement, 2× 500 mg softgel daily (1000 mg curcumin per day), 2 times a day, for 2 months

omega 3 fatty acid Placebo

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

Group Type: PLACEBO_COMPARATOR

omega 3 fatty acid placebo

Intervention Type: DIETARY_SUPPLEMENT

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

curcumin placebo

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

Group Type: PLACEBO_COMPARATOR

curcumin placebo

Intervention Type: DIETARY_SUPPLEMENT

curcumin placebo softgel (Containing 1 g starch powder), 2× 500 mg softgel daily (1 g per day), 2 times a day, for 2 months

Interventions

omega 3 fatty acid

omega 3 fatty acid supplement, 2× 1000 mg softgel daily (1800 mg EPA+DHA per day), 2 times a day, for 2 months

Intervention Type: DIETARY_SUPPLEMENT

curcumin

curcumin supplement, 2× 500 mg softgel daily (1000 mg curcumin per day), 2 times a day, for 2 months

Intervention Type: DIETARY_SUPPLEMENT

omega 3 fatty acid placebo

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

Intervention Type: DIETARY_SUPPLEMENT

curcumin placebo

curcumin placebo softgel (Containing 1 g starch powder), 2× 500 mg softgel daily (1 g per day), 2 times a day, for 2 months

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

n-3 PUFA; n-3 Fatty Acid

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tehran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Djalali M, Talebi S, Djalali E, Abdolahi M, Travica N, Djalali M. The effect of omega-3 fatty acids supplementation on inflammatory biomarkers in subjects with migraine: a randomized, double-blind, placebo-controlled trial. Immunopharmacol Immunotoxicol. 2023 Oct;45(5):565-570. doi: 10.1080/08923973.2023.2196600. Epub 2023 Apr 26.

Reference Type: DERIVED

PMID: 37126739 (View on PubMed)

Abdolahi M, Karimi E, Sarraf P, Tafakhori A, Siri G, Salehinia F, Sedighiyan M, Asanjarani B, Badeli M, Abdollahi H, Yoosefi N, Yousefi A, Rad AS, Djalali M. The omega-3 and Nano-curcumin effects on vascular cell adhesion molecule (VCAM) in episodic migraine patients: a randomized clinical trial. BMC Res Notes. 2021 Jul 23;14(1):283. doi: 10.1186/s13104-021-05700-x.

Reference Type: DERIVED

PMID: 34301320 (View on PubMed)

Abdolahi M, Sarraf P, Javanbakht MH, Honarvar NM, Hatami M, Soveyd N, Tafakhori A, Sedighiyan M, Djalali M, Jafarieh A, Masoudian Y, Djalali M. A Novel Combination of omega-3 Fatty Acids and Nano-Curcumin Modulates Interleukin-6 Gene Expression and High Sensitivity C-reactive Protein Serum Levels in Patients with Migraine: A Randomized Clinical Trial Study. CNS Neurol Disord Drug Targets. 2018;17(6):430-438. doi: 10.2174/1871527317666180625101643.

Reference Type: DERIVED

PMID: 29938621 (View on PubMed)

Other Identifiers

28825

Identifier Type: -

Identifier Source: org_study_id