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Completed

NCT Number: NCT02666807

Effects of Ginger Supplementation on NF-KB in Peripheral Blood Mononuclear Cells in 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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ginger

Dietary Supplement

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

Other names: Zingiber officinale Roscoe

Placebo

Dietary Supplement

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

Other names: wheat flour capsules

Primary outcomes

  1. Change from Baseline in NF-KB at 10 weeks

    Time frame: Baseline and 10 weeks

Secondary outcomes

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

    Time frame: Baseline and 10 weeks

    FBS (Fasting Blood sugar) (mg/dl)

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

    Time frame: Baseline and 10 weeks

    HDL-C (High Density Lipoprotein) (mg/dl)

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

    Time frame: Baseline and 10 weeks

    LDL-C (Low Density Lipoprotein) (mg/dl)

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

    Time frame: Baseline and 10 weeks

    Total-C (Total Cholesterol) (mg/dl)

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

    Time frame: Baseline and 10 weeks

    TG (Triacylglycerol) (mg/dl)

  6. Change from Baseline in Hb A1C at 10 weeks

    Time frame: Baseline and 10 weeks

    Hb A1C (Glycated hemoglobin)

  7. Change from Baseline in insulin (µlU/ml) at 10 weeks

    Time frame: Baseline and 10 weeks

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 28, 2016
Registry last updated
Jan 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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