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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-11-30

Brief Summary

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This study evaluates the effect of ginger on NF-KB level in Peripheral Blood Mononuclear Cells in type 2 diabetic patients. Half of patients will receive ginger, while the other half will receive placebo.

Detailed Description

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ginger is a plant with lots of phytochemicals which have antioxidant effects. It reduces the NF-KB levels in the cells because of its antioxidant effects. It can reduces insulin resistance as a result of NF-KB reduction in diabetes.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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

Group Type EXPERIMENTAL

Ginger

Intervention Type DIETARY_SUPPLEMENT

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

placebo

Placebo matching with ginger 0 mg capsules by mouth twice daily (BID) for 10 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Zingiber officinale Roscoe wheat flour capsules

Eligibility Criteria

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Inclusion Criteria

* type 2 of diabetes diagnosed for 1 to 10 years
* age 30-60 years
* BMI = 18.5-35 kg/m\*m
* treatment with Metformin or Glibenclamide

Exclusion Criteria

* Treatment with insulin
* 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Niaz Mohammadzadeh Honarvar

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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.

Reference Type RESULT
PMID: 19233241 (View on PubMed)

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.

Reference Type RESULT
PMID: 17950516 (View on PubMed)

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.

Reference Type RESULT
PMID: 23843863 (View on PubMed)

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.

Reference Type RESULT
PMID: 3448918 (View on PubMed)

Other Identifiers

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TehranUMS

Identifier Type: -

Identifier Source: org_study_id

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