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

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

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.

Study Overview

• Status: Unknown
• Conditions: Migraine
• Intervention / Treatment: Dietary supplement: omega 3 fatty acid; Dietary supplement: curcumin; Dietary supplement: omega 3 fatty acid placebo; Dietary supplement: curcumin placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: omega 3 fatty acid supplementation; patients with migraine receive 2 capsules 1000 mg omega3, 2 times a day, for 2 months.	Dietary supplement: 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; Other Names: n-3 PUFA; n-3 Fatty Acid
Active Comparator: curcumin supplementation; patients with migraine receive 2 capsules 1000 mg curcumin, 2 times a day, for 2 months.	Dietary supplement: curcumin; curcumin supplement, 2× 500 mg softgel daily (1000 mg curcumin per day), 2 times a day, for 2 months
Placebo Comparator: omega 3 fatty acid Placebo; patients with migraine receive 2 capsules of omega 3 fatty acid placebo for 2 months.	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
Placebo Comparator: curcumin placebo; patients with migraine receive 2 capsules of curcumin placebo for 2 months.	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): February 1, 2017

Study Registration Dates

• First Submitted: August 21, 2015
• First Submitted That Met QC Criteria: August 24, 2015
• First Posted (Estimate): August 25, 2015

Study Record Updates

• Last Update Posted (Estimate): August 25, 2015
• Last Update Submitted That Met QC Criteria: August 24, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: IL-6; migraine; COX-2; curcumin; hsCRP; TNF-α; IL-1β; omega 3 fatty acid; iNOs; VCAM-1; ICAM-1
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: 28825