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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Dietary Supplement: Ginger; Dietary Supplement: placebo

• Registration Number: NCT02666807
• Lead Sponsor: Tehran University of Medical Sciences

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.

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-01
• Study First Submitted: 2016-01-10
• Study First Submitted QC: 2016-01-25
• Last Update Submitted: 2016-01-25
• Study First Posted: 2016-01-28
• Last Update Posted: 2016-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ginger	Ginger	Ginger (Zingiber officinale Roscoe) 500 mg capsules (2000 mg per day) by mouth twice daily (BID) for 10 weeks
Placebo	placebo	Placebo matching with ginger 0 mg capsules by mouth twice daily (BID) for 10 weeks Placebo twice daily

Primary Outcome Measures

Name	Time	Method
Change from Baseline in NF-KB at 10 weeks	Baseline and 10 weeks

Secondary Outcome Measures

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