Clinical trial NCT02532023: The Combined Effects of omega3 Fatty Acids and Curcumin Supplementation on Inflammatory and Endothelial Factors in Migraine Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Migraine
Keywords: omega 3 fatty acid
curcumin
COX-2
iNOs
VCAM-1
ICAM-1
IL-1β
IL-6
TNF-α
hsCRP
migraine
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-08-25
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: headache attack
timeFrame: Change frome baseline at 2 months
Secondary outcomes:
measure: serum COX-2
timeFrame: Change frome baseline at 2 months
measure: serum iNOs
timeFrame: Change frome baseline at 2 months
measure: serum VCAM-1
timeFrame: Change frome baseline at 2 months
measure: serum ICAM-1
timeFrame: Change frome baseline at 2 months
measure: serum TNF-α
timeFrame: Change frome baseline at 2 months
measure: serum IL-1β
timeFrame: Change frome baseline at 2 months
measure: serum IL-6
timeFrame: Change frome baseline at 2 months
measure: serum hsCRP
timeFrame: Change frome baseline at 2 months
measure: headache duration
timeFrame: Change frome baseline at 2 months
measure: headache severity
timeFrame: Change frome baseline at 2 months
measure: COX-2 gene expression
timeFrame: Change frome baseline at 2 months
measure: iNOs gene expression
timeFrame: Change frome baseline at 2 months
measure: VCAM-1 gene expression
timeFrame: Change frome baseline at 2 months
measure: ICAM-1 gene expression
timeFrame: Change frome baseline at 2 months
measure: TNF-α gene expression
timeFrame: Change frome baseline at 2 months
measure: IL-1β gene expression
timeFrame: Change frome baseline at 2 months
measure: IL-6 gene expression
timeFrame: Change frome baseline at 2 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.