NCT02666807CompletedNot Applicable
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
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Primary Endpoint
- Change from Baseline in NF-KB at 10 weeks
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- 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
- •Currently suffering from acute illness that needs medical treatment
Arms & Interventions
Placebo
Placebo Comparator
Placebo matching with ginger 0 mg capsules by mouth twice daily (BID) for 10 weeks Placebo twice daily
Intervention: placebo (Dietary Supplement)
Ginger
Experimental
Ginger (Zingiber officinale Roscoe) 500 mg capsules (2000 mg per day) by mouth twice daily (BID) for 10 weeks
Intervention: Ginger (Dietary Supplement)
Outcomes
Primary Outcomes
Change from Baseline in NF-KB at 10 weeks
Time Frame: Baseline and 10 weeks
Secondary Outcomes
- Change from Baseline in LDL-C (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 TG (mg/dl) at 10 weeks(Baseline and 10 weeks)
- Change from Baseline in insulin (µlU/ml) at 10 weeks(Baseline and 10 weeks)
- Change from Baseline in Hb A1C at 10 weeks(Baseline and 10 weeks)
- Change from Baseline in FBS (mg/dl) at 10 weeks(Baseline and 10 weeks)
- Change from Baseline in Total-C (mg/dl) at 10 weeks(Baseline and 10 weeks)
Investigators
Niaz Mohammadzadeh Honarvar
Assistant Professor
Tehran University of Medical Sciences
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