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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Ginger
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ginger<br>Ginger (Zingiber officinale Roscoe) 500 mg capsules (2000 mg per day) by mouth twice daily (BID) for 10 weeks | Dietary Supplement: Ginger<br>* Ginger 500 mg capsules (2000 mg per day) by mouth twice daily (BID) for 10 weeks<br>* Other names: Zingiber officinale Roscoe;|
| Placebo Comparator: Placebo<br>Placebo matching with ginger 0 mg capsules by mouth twice daily (BID) for 10 weeks Placebo twice daily | Dietary Supplement: placebo<br>* Placebo matching with ginger 0 mg capsules by mouth twice daily (BID) for 10 weeks<br>* Other names: wheat flour capsules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in NF-KB at 10 weeks |  | Baseline and 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in FBS (mg/dl) at 10 weeks | FBS (Fasting Blood sugar) (mg/dl) | Baseline and 10 weeks | 
| Change from Baseline in HDL-C (mg/dl) at 10 weeks | HDL-C (High Density Lipoprotein) (mg/dl) | Baseline and 10 weeks | 
| Change from Baseline in LDL-C (mg/dl) at 10 weeks | LDL-C (Low Density Lipoprotein) (mg/dl) | Baseline and 10 weeks | 
| Change from Baseline in Total-C (mg/dl) at 10 weeks | Total-C (Total Cholesterol) (mg/dl) | Baseline and 10 weeks | 
| Change from Baseline in TG (mg/dl) at 10 weeks | TG (Triacylglycerol) (mg/dl) | Baseline and 10 weeks | 
| Change from Baseline in Hb A1C at 10 weeks | Hb A1C (Glycated hemoglobin) | Baseline and 10 weeks | 
| Change from Baseline in insulin (µlU/ml) at 10 weeks |  | Baseline and 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NF-κB, Ginger