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

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ClinicalTrials.gov Identifier: NCT02532023
Recruitment Status : Unknown
Verified August 2015 by Tehran University of Medical Sciences.
Recruitment status was:  Enrolling by invitation
First Posted : August 25, 2015
Last Update Posted : August 25, 2015
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE August 21, 2015
First Posted Date  ICMJE August 25, 2015
Last Update Posted Date August 25, 2015
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2015)
headache attack [ Time Frame: Change frome baseline at 2 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2015)
  • serum COX-2 [ Time Frame: Change frome baseline at 2 months ]
  • serum iNOs [ Time Frame: Change frome baseline at 2 months ]
  • serum VCAM-1 [ Time Frame: Change frome baseline at 2 months ]
  • serum ICAM-1 [ Time Frame: Change frome baseline at 2 months ]
  • serum TNF-α [ Time Frame: Change frome baseline at 2 months ]
  • serum IL-1β [ Time Frame: Change frome baseline at 2 months ]
  • serum IL-6 [ Time Frame: Change frome baseline at 2 months ]
  • serum hsCRP [ Time Frame: Change frome baseline at 2 months ]
  • headache duration [ Time Frame: Change frome baseline at 2 months ]
  • headache severity [ Time Frame: Change frome baseline at 2 months ]
  • COX-2 gene expression [ Time Frame: Change frome baseline at 2 months ]
  • iNOs gene expression [ Time Frame: Change frome baseline at 2 months ]
  • VCAM-1 gene expression [ Time Frame: Change frome baseline at 2 months ]
  • ICAM-1 gene expression [ Time Frame: Change frome baseline at 2 months ]
  • TNF-α gene expression [ Time Frame: Change frome baseline at 2 months ]
  • IL-1β gene expression [ Time Frame: Change frome baseline at 2 months ]
  • IL-6 gene expression [ Time Frame: Change frome baseline at 2 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Combined Effects of omega3 Fatty Acids and Curcumin Supplementation on Inflammatory and Endothelial Factors in Migraine Patients
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Condition  ICMJE Migraine
Intervention  ICMJE
  • 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
  • Dietary Supplement: curcumin
    curcumin supplement, 2× 500 mg softgel daily (1000 mg curcumin per day), 2 times a day, 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
  • 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
Study Arms  ICMJE
  • Active Comparator: omega 3 fatty acid supplementation
    patients with migraine receive 2 capsules 1000 mg omega3, 2 times a day, for 2 months.
    Intervention: Dietary Supplement: omega 3 fatty acid
  • Active Comparator: curcumin supplementation
    patients with migraine receive 2 capsules 1000 mg curcumin, 2 times a day, for 2 months.
    Intervention: Dietary Supplement: curcumin
  • Placebo Comparator: omega 3 fatty acid Placebo
    patients with migraine receive 2 capsules of omega 3 fatty acid placebo for 2 months.
    Intervention: Dietary Supplement: omega 3 fatty acid placebo
  • Placebo Comparator: curcumin placebo
    patients with migraine receive 2 capsules of curcumin placebo for 2 months.
    Intervention: Dietary Supplement: curcumin placebo
Publications * 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 ω-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 24, 2015)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2017
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02532023
Other Study ID Numbers  ICMJE 28825
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tehran University of Medical Sciences
Study Sponsor  ICMJE Tehran University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tehran University of Medical Sciences
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP