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

NCT02532023 | Unknown Phase 4 DMC

• 1 other identifier: 28825
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Migraine

Keywords

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

Outcome Measures

Primary Outcomes (1)

• headache attack

  Change frome baseline at 2 months

Secondary Outcomes (17)

• 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

Study Arms (4)

omega 3 fatty acid supplementation

ACTIVE COMPARATOR

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

Dietary Supplement: omega 3 fatty acid

curcumin supplementation

ACTIVE COMPARATOR

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

Dietary Supplement: curcumin

omega 3 fatty acid Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: omega 3 fatty acid placebo

curcumin placebo

PLACEBO COMPARATOR

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

Dietary Supplement: curcumin placebo

Interventions

omega 3 fatty acid 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

Also known as: n-3 PUFA, n-3 Fatty Acid

omega 3 fatty acid supplementation

curcumin DIETARY_SUPPLEMENT

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

curcumin supplementation

omega 3 fatty acid placebo 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

omega 3 fatty acid Placebo

curcumin placebo 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

curcumin placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Related Publications (3)

• 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.

  PMID: 37126739 DERIVED

• 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.

  PMID: 34301320 DERIVED

• 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.

  PMID: 29938621 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Fatty Acids, Omega-3; Curcumin

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: August 25, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: February 1, 2017
• Last Updated: August 25, 2015

Record last verified: 2015-08