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

Migraine Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02532023
• Other study ID #: 28825
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: August 21, 2015
• Last updated: August 24, 2015
• Start date: September 2015
• Est. completion date: February 2017

Study information

• Verified date: August 2015
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: February 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	headache attack		Change frome baseline at 2 months	Yes
Secondary	serum COX-2		Change frome baseline at 2 months	Yes
Secondary	serum iNOs		Change frome baseline at 2 months	Yes
Secondary	serum VCAM-1		Change frome baseline at 2 months	Yes
Secondary	serum ICAM-1		Change frome baseline at 2 months	Yes
Secondary	serum TNF-a		Change frome baseline at 2 months	Yes
Secondary	serum IL-1ß		Change frome baseline at 2 months	Yes
Secondary	serum IL-6		Change frome baseline at 2 months	Yes
Secondary	serum hsCRP		Change frome baseline at 2 months	Yes
Secondary	headache duration		Change frome baseline at 2 months	Yes
Secondary	headache severity		Change frome baseline at 2 months	Yes
Secondary	COX-2 gene expression		Change frome baseline at 2 months	Yes
Secondary	iNOs gene expression		Change frome baseline at 2 months	Yes
Secondary	VCAM-1 gene expression		Change frome baseline at 2 months	Yes
Secondary	ICAM-1 gene expression		Change frome baseline at 2 months	Yes
Secondary	TNF-a gene expression		Change frome baseline at 2 months	Yes
Secondary	IL-1ß gene expression		Change frome baseline at 2 months	Yes
Secondary	IL-6 gene expression		Change frome baseline at 2 months	Yes