Clincosm LogoSign in Get a demo

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

Sponsor
Tehran University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT02666807
Collaborator
(none)
50
Enrollment
2
Arms
5
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Ginger
  • Dietary Supplement: placebo
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
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
Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Nov 1, 2015
Actual Study Completion Date :
Nov 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ginger

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

Dietary Supplement: Ginger
Ginger 500 mg capsules (2000 mg per day) by mouth twice daily (BID) for 10 weeks
Other Names:
  • Zingiber officinale Roscoe

    		•
    Placebo Comparator: Placebo

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

    Dietary Supplement: placebo
    Placebo matching with ginger 0 mg capsules by mouth twice daily (BID) for 10 weeks
    Other Names:
  • wheat flour capsules

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

      FBS (Fasting Blood sugar) (mg/dl)

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

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

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

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

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

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

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

      TG (Triacylglycerol) (mg/dl)

    6. Change from Baseline in Hb A1C at 10 weeks [Baseline and 10 weeks]

      Hb A1C (Glycated hemoglobin)

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Tehran University of Medical Sciences

    Investigators

    • Study Director: Ahmad Saedisomeolia, Prof.assoc, Tehran University of Medical Sciences
    • Principal Investigator: Motahare Makhdoomiarzati, Msc student, Tehran University of Medical Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Niaz Mohammadzadeh Honarvar, Assistant Professor, Tehran University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT02666807
    Other Study ID Numbers:
    • TehranUMS
    First Posted:
    Jan 28, 2016
    Last Update Posted:
    Jan 28, 2016
    Last Verified:
    Jan 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Niaz Mohammadzadeh Honarvar, Assistant Professor, Tehran University of Medical Sciences
    NF-κB
    Ginger
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Jan 28, 2016