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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02666807

Enrollment

Registered

2016-01-28

Start date

2015-06-30

Completion date

2015-11-30

Last updated

2016-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

NF-κB, Ginger

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.

Interventions

DIETARY_SUPPLEMENTGinger

Ginger 500 mg capsules (2000 mg per day) by mouth twice daily (BID) for 10 weeks

DIETARY_SUPPLEMENTplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026