Clinical trial NCT02666807: Effects of Ginger Supplementation on NF-KB in Peripheral Blood Mononuclear Cells in Type 2 Diabetes Mellitus
Official title: Effects of Oral Ginger Supplementation on NF-KB (Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells) in Peripheral Blood Mononuclear Cells (PBMC) and Glycemic and Lipid Profiles in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: NF-κB
Ginger
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in NF-KB at 10 weeks
timeFrame: Baseline and 10 weeks
Secondary outcomes:
measure: Change from Baseline in FBS (mg/dl) at 10 weeks
timeFrame: Baseline and 10 weeks
measure: Change from Baseline in HDL-C (mg/dl) at 10 weeks
timeFrame: Baseline and 10 weeks
measure: Change from Baseline in LDL-C (mg/dl) at 10 weeks
timeFrame: Baseline and 10 weeks
measure: Change from Baseline in Total-C (mg/dl) at 10 weeks
timeFrame: Baseline and 10 weeks
measure: Change from Baseline in TG (mg/dl) at 10 weeks
timeFrame: Baseline and 10 weeks
measure: Change from Baseline in Hb A1C at 10 weeks
timeFrame: Baseline and 10 weeks
measure: Change from Baseline in insulin (µlU/ml) at 10 weeks
timeFrame: Baseline and 10 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Tehran University of Medical Sciences
name: Ahmad Saedisomeolia, Prof.assoc
role: STUDY_DIRECTOR
affiliation: Tehran University of Medical Sciences
name: Motahare Makhdoomiarzati, Msc student
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.