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

NCT02666807 | Completed DMC

• 1 other identifier: TehranUMS
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

NF-κB; Ginger

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in NF-KB at 10 weeks

  Baseline and 10 weeks

Secondary Outcomes (7)

• Change from Baseline in FBS (mg/dl) at 10 weeks

  Baseline and 10 weeks

• Change from Baseline in HDL-C (mg/dl) at 10 weeks

  Baseline and 10 weeks

• Change from Baseline in LDL-C (mg/dl) at 10 weeks

  Baseline and 10 weeks

• Change from Baseline in Total-C (mg/dl) at 10 weeks

  Baseline and 10 weeks

• Change from Baseline in TG (mg/dl) at 10 weeks

  Baseline and 10 weeks

Study Arms (2)

Ginger

EXPERIMENTAL

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

Dietary Supplement: Ginger

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: placebo

Interventions

Ginger DIETARY_SUPPLEMENT

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

Also known as: Zingiber officinale Roscoe

Ginger

placebo DIETARY_SUPPLEMENT

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

Also known as: wheat flour capsules

Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Related Publications (4)

• 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.

  PMID: 19233241 RESULT

• 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.

  PMID: 17950516 RESULT

• 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.

  PMID: 23843863 RESULT

• 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.

  PMID: 3448918 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

ginger extract; Flour

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ahmad Saedisomeolia, Prof.assoc

  Tehran University of Medical Sciences

  STUDY DIRECTOR

• Motahare Makhdoomiarzati, Msc student

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 10, 2016
• First Posted: January 28, 2016
• Study Start: June 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 28, 2016

Record last verified: 2016-01