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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02666807
• Other study ID #: TehranUMS
• Status: Completed
• Phase: N/A
• First received: January 10, 2016
• Last updated: January 25, 2016
• Start date: June 2015
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Ginger
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

References & Publications (4)

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. Epub 2007 Sep 18. Review. — View 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. 200 — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in NF-KB at 10 weeks		Baseline and 10 weeks	No
Secondary	Change from Baseline in FBS (mg/dl) at 10 weeks	FBS (Fasting Blood sugar) (mg/dl)	Baseline and 10 weeks	No
Secondary	Change from Baseline in HDL-C (mg/dl) at 10 weeks	HDL-C (High Density Lipoprotein) (mg/dl)	Baseline and 10 weeks	No
Secondary	Change from Baseline in LDL-C (mg/dl) at 10 weeks	LDL-C (Low Density Lipoprotein) (mg/dl)	Baseline and 10 weeks	No
Secondary	Change from Baseline in Total-C (mg/dl) at 10 weeks	Total-C (Total Cholesterol) (mg/dl)	Baseline and 10 weeks	No
Secondary	Change from Baseline in TG (mg/dl) at 10 weeks	TG (Triacylglycerol) (mg/dl)	Baseline and 10 weeks	No
Secondary	Change from Baseline in Hb A1C at 10 weeks	Hb A1C (Glycated hemoglobin)	Baseline and 10 weeks	No
Secondary	Change from Baseline in insulin (µlU/ml) at 10 weeks		Baseline and 10 weeks	No