Effects of Ginger Supplementation on NF-KB in Peripheral Blood Mononuclear Cells in Type 2 Diabetes Mellitus
NCT ID: NCT02666807
Last Updated: 2016-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2015-06-30
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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Ginger
Ginger (Zingiber officinale Roscoe) 500 mg capsules (2000 mg per day) by mouth twice daily (BID) for 10 weeks
Ginger
Ginger 500 mg capsules (2000 mg per day) by mouth twice daily (BID) for 10 weeks
Placebo
Placebo matching with ginger 0 mg capsules by mouth twice daily (BID) for 10 weeks Placebo twice daily
placebo
Placebo matching with ginger 0 mg capsules by mouth twice daily (BID) for 10 weeks
Interventions
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Ginger
Ginger 500 mg capsules (2000 mg per day) by mouth twice daily (BID) for 10 weeks
placebo
Placebo matching with ginger 0 mg capsules by mouth twice daily (BID) for 10 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age 30-60 years
* BMI = 18.5-35 kg/m\*m
* treatment with Metformin or Glibenclamide
Exclusion Criteria
* Weight loss more than 10% in 6 months
* Treatment with TZDs (thiazolidinediones)
* Pregnancy and breast feeding
* Smoking and alcohol consumption
* Multivitamin-mineral and polyphenols and omega-3 and 6 supplementation in the last 3 months and during study
* Ginger supplementation and herbal medicines
* Anticoagulation consumption such as heparin and warfarin
* NSAIDs such as diclofenac and salicylate drugs such as aspirin, corticosteroids such as prednisone consumption during 1 month ago and during the study
* Infectious and inflammatory diseases such as rheumatoid arthritis
* Impaired hepatic, renal and gastrointestinal function
* Cancer
* Currently suffering from acute illness that needs medical treatment
30 Years
60 Years
ALL
No
Sponsors
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Tehran University of Medical Sciences
OTHER
Responsible Party
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Niaz Mohammadzadeh Honarvar
Assistant Professor
Principal Investigators
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Ahmad Saedisomeolia, Prof.assoc
Role: STUDY_DIRECTOR
Tehran University of Medical Sciences
Motahare Makhdoomiarzati, Msc student
Role: PRINCIPAL_INVESTIGATOR
Tehran University of Medical Sciences
References
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Jung HW, Yoon CH, Park KM, Han HS, Park YK. Hexane fraction of Zingiberis Rhizoma Crudus extract inhibits the production of nitric oxide and proinflammatory cytokines in LPS-stimulated BV2 microglial cells via the NF-kappaB pathway. Food Chem Toxicol. 2009 Jun;47(6):1190-7. doi: 10.1016/j.fct.2009.02.012. Epub 2009 Feb 20.
Ali BH, Blunden G, Tanira MO, Nemmar A. Some phytochemical, pharmacological and toxicological properties of ginger (Zingiber officinale Roscoe): a review of recent research. Food Chem Toxicol. 2008 Feb;46(2):409-20. doi: 10.1016/j.fct.2007.09.085. Epub 2007 Sep 18.
Li XH, McGrath KC, Tran VH, Li YM, Duke CC, Roufogalis BD, Heather AK. Attenuation of Proinflammatory Responses by S-[6]-Gingerol via Inhibition of ROS/NF-Kappa B/COX2 Activation in HuH7 Cells. Evid Based Complement Alternat Med. 2013;2013:146142. doi: 10.1155/2013/146142. Epub 2013 Jun 16.
Ogawa Y, Yamaguchi K, Tanaka T, Morozumi M, Kitagawa R. [Evaluation of the enzymatic method using oxalate oxidase for urinary oxalate assay]. Hinyokika Kiyo. 1987 Dec;33(12):1951-4. Japanese.
Other Identifiers
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TehranUMS
Identifier Type: -
Identifier Source: org_study_id
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