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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02532023
Enrollment
80
Registered
2015-08-25
Start date
2015-09-30
Completion date
2017-02-28
Last updated
2015-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Keywords

omega 3 fatty acid, curcumin, COX-2, iNOs, VCAM-1, ICAM-1, IL-1β, IL-6, TNF-α, hsCRP, migraine

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.

Interventions

DIETARY_SUPPLEMENTomega 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

DIETARY_SUPPLEMENTcurcumin

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

DIETARY_SUPPLEMENTomega 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

DIETARY_SUPPLEMENTcurcumin 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

Sponsors

Tehran University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
headache attackChange frome baseline at 2 months

Secondary

MeasureTime frame
serum iNOsChange frome baseline at 2 months
serum VCAM-1Change frome baseline at 2 months
serum ICAM-1Change frome baseline at 2 months
serum TNF-αChange frome baseline at 2 months
serum IL-1βChange frome baseline at 2 months
serum IL-6Change frome baseline at 2 months
serum hsCRPChange frome baseline at 2 months
headache durationChange frome baseline at 2 months
serum COX-2Change frome baseline at 2 months
COX-2 gene expressionChange frome baseline at 2 months
iNOs gene expressionChange frome baseline at 2 months
VCAM-1 gene expressionChange frome baseline at 2 months
ICAM-1 gene expressionChange frome baseline at 2 months
TNF-α gene expressionChange frome baseline at 2 months
IL-1β gene expressionChange frome baseline at 2 months
IL-6 gene expressionChange frome baseline at 2 months
headache severityChange frome baseline at 2 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026