Effects of Ginger Supplementation on NF-KB in Peripheral Blood Mononuclear Cells in Type 2 Diabetes Mellitus

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Dietary supplement: Ginger; Dietary supplement: 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ginger; Ginger (Zingiber officinale Roscoe) 500 mg capsules (2000 mg per day) by mouth twice daily (BID) for 10 weeks	Dietary supplement: Ginger; Ginger 500 mg capsules (2000 mg per day) by mouth twice daily (BID) for 10 weeks; Other Names: Zingiber officinale Roscoe
Placebo Comparator: Placebo; Placebo matching with ginger 0 mg capsules by mouth twice daily (BID) for 10 weeks Placebo twice daily	Dietary supplement: placebo; Placebo matching with ginger 0 mg capsules by mouth twice daily (BID) for 10 weeks; Other Names: wheat flour capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in NF-KB at 10 weeks	Baseline and 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in FBS (mg/dl) at 10 weeks	FBS (Fasting Blood sugar) (mg/dl)	Baseline and 10 weeks
Change from Baseline in HDL-C (mg/dl) at 10 weeks	HDL-C (High Density Lipoprotein) (mg/dl)	Baseline and 10 weeks
Change from Baseline in LDL-C (mg/dl) at 10 weeks	LDL-C (Low Density Lipoprotein) (mg/dl)	Baseline and 10 weeks
Change from Baseline in Total-C (mg/dl) at 10 weeks	Total-C (Total Cholesterol) (mg/dl)	Baseline and 10 weeks
Change from Baseline in TG (mg/dl) at 10 weeks	TG (Triacylglycerol) (mg/dl)	Baseline and 10 weeks
Change from Baseline in Hb A1C at 10 weeks	Hb A1C (Glycated hemoglobin)	Baseline and 10 weeks
Change from Baseline in insulin (µlU/ml) at 10 weeks		Baseline and 10 weeks

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences
• Investigators: Study Director: Ahmad Saedisomeolia, Prof.assoc, Tehran University of Medical Sciences; Principal Investigator: Motahare Makhdoomiarzati, Msc student, Tehran University of Medical Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: January 10, 2016
• First Submitted That Met QC Criteria: January 25, 2016
• First Posted (Estimate): January 28, 2016

Study Record Updates

• Last Update Posted (Estimate): January 28, 2016
• Last Update Submitted That Met QC Criteria: January 25, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Ginger; NF-κB
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: TehranUMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided