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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

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.

Condition or disease Intervention/treatment Phase
Migraine Dietary Supplement: omega 3 fatty acid Dietary Supplement: curcumin Dietary Supplement: omega 3 fatty acid placebo Dietary Supplement: curcumin placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
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 Start Date : September 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Active Comparator: omega 3 fatty acid supplementation
patients with migraine receive 2 capsules 1000 mg omega3, 2 times a day, for 2 months.
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

Active Comparator: curcumin supplementation
patients with migraine receive 2 capsules 1000 mg curcumin, 2 times a day, for 2 months.
Dietary Supplement: curcumin
curcumin supplement, 2× 500 mg softgel daily (1000 mg curcumin per day), 2 times a day, for 2 months

Placebo Comparator: omega 3 fatty acid Placebo
patients with migraine receive 2 capsules of omega 3 fatty acid placebo 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

Placebo Comparator: curcumin placebo
patients with migraine receive 2 capsules of curcumin placebo 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




Primary Outcome Measures :
  1. headache attack [ Time Frame: Change frome baseline at 2 months ]

Secondary Outcome Measures :
  1. serum COX-2 [ Time Frame: Change frome baseline at 2 months ]
  2. serum iNOs [ Time Frame: Change frome baseline at 2 months ]
  3. serum VCAM-1 [ Time Frame: Change frome baseline at 2 months ]
  4. serum ICAM-1 [ Time Frame: Change frome baseline at 2 months ]
  5. serum TNF-α [ Time Frame: Change frome baseline at 2 months ]
  6. serum IL-1β [ Time Frame: Change frome baseline at 2 months ]
  7. serum IL-6 [ Time Frame: Change frome baseline at 2 months ]
  8. serum hsCRP [ Time Frame: Change frome baseline at 2 months ]
  9. headache duration [ Time Frame: Change frome baseline at 2 months ]
  10. headache severity [ Time Frame: Change frome baseline at 2 months ]
  11. COX-2 gene expression [ Time Frame: Change frome baseline at 2 months ]
  12. iNOs gene expression [ Time Frame: Change frome baseline at 2 months ]
  13. VCAM-1 gene expression [ Time Frame: Change frome baseline at 2 months ]
  14. ICAM-1 gene expression [ Time Frame: Change frome baseline at 2 months ]
  15. TNF-α gene expression [ Time Frame: Change frome baseline at 2 months ]
  16. IL-1β gene expression [ Time Frame: Change frome baseline at 2 months ]
  17. IL-6 gene expression [ Time Frame: Change frome baseline at 2 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02532023     History of Changes
Other Study ID Numbers: 28825
First Posted: August 25, 2015    Key Record Dates
Last Update Posted: August 25, 2015
Last Verified: August 2015

Keywords provided by Tehran University of Medical Sciences:
omega 3 fatty acid
curcumin
COX-2
iNOs
VCAM-1
ICAM-1
IL-1β
IL-6
TNF-α
hsCRP
migraine

Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action