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Effects of Red Grape Cells (RGC) Powder in Type 2 Diabetics (RGC-T2D)

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ClinicalTrials.gov Identifier: NCT01938521
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
Wolfson Medical Center
Information provided by (Responsible Party):
Daniela Jakubowicz, Tel Aviv University

Brief Summary:
The aim of this study is to examine whether the chronic administration during 12 weeks of polyphenols contained in Red Grape Cells (RGC) powder has an effect on mRNA expression of SIRT1 and Clock Genes, on circulating levels of HbA1c, lipids, blood pressure and on postprandial response of glucose, lipids, insulin, C-peptide and GLP-1 in patients with type 2 diabetes .

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Dietary Supplement: Red Grape Cells (RGC) Dietary Supplement: Placebo (for Red Grape Cells (RGC)) Not Applicable

Detailed Description:

There is a growing body of evidence demonstrating that polyphenols and specially the most investigated Resveratrol contained in the Red Grape Cells (RGC) exert beneficial effects on several markers of metabolic syndrome i.e. antioxidant, anti-inflammatory, anti-atherosclerotic, vasodilator and antihypertensive activity.

Many of this beneficial metabolic effects of polyphenols, occurs via activation of sirtuin-1 or silent information regulator-1 gene (SIRT1). This gene is expressed in adipose tissue, muscle, endothelium, peripheral blood cells, etc where it plays a pivotal role in the regulation of Circadian Clock Genes (CCG) involved in glucose lipid metabolism, endothelial function, etc .

By activation of SIRT1 and CCG the polyphenols, may influence the circadian secretion of adiponectin, insulin, asymmetric dimethylarginine (ADMA) and other hormones that influence insulin sensitivity, muscular glucose uptake, NO synthesis, nocturnal hepatic glucose production, lipolisis and endothelial function It was shown in several studies in animals and in clinical studies in subjects with metabolic syndrome that SIRT1 expression and its regulation of the CCG, improves insulin sensitivity in skeletal muscle, preventing weight gain; improves pancreatic beta-cell function enhancing insulin secretion and glucose tolerance. It was associated with increased lipolisis in white adipose tissue, decreased glycolysis, increased fatty acid oxidation in skeletal muscle and with increase Nitric Oxide in the endothelium.

Given that polyphenols directly on the clock genes or by enhancing SIRT1 expression appears to counter some of the effects of a high-fat diet, obesity and metabolic syndrome, by protecting against insulin resistance, hyperglycemia, and dyslipidemia and endothelial dysfunction.

It rise the possibility that the polyphenols contained in Red Grape Cells (RGC) by activation SIRT1 may also exert beneficial effects in subjects affected by type 2 diabetes


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Red Grape Cells (RGC) Powder on Glycemic and Lipid Control in Patients With Type 2 Diabetes ¬ A Double-blind, Randomized, Placebo Controlled Study
Study Start Date : September 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Red Grape Cells (RGC)
Red Grape Cells (RGC) 1000 mg powder once daily by mouth for three month
Dietary Supplement: Red Grape Cells (RGC)
Red Grape Cells (RGC) 1000 mg powder once daily by mouth for three month
Other Name: RGC

Placebo Comparator: Placebo (for Red Grape Cells (RGC))
Placebo (for Red Grape Cells (RGC)) similar powder to mimic 1000 mg of Red Grape Cells (RGC), once daily by mouth for three month
Dietary Supplement: Placebo (for Red Grape Cells (RGC))
Placebo (for Red Grape Cells (RGC)) powder manufactured to mimic Red Grape Cells (RGC) 1000 mg powder
Other Name: RGC Placebo




Primary Outcome Measures :
  1. Fasting and postprandial Clock Genes expression in peripheral blood cells (PBC) [ Time Frame: Fasting and every hour after meal challenge in two occasions : at baseline (day 1) and after 12 weeks of of supplementation with RGC or Placebo . ]
    In all 40 subjects the effects of 12 weeks supplementation with RGC or placebo will be assessed .The clock gene expression will be measured in peripheral blood cells (PBC), at baseline (Day 1) and again after 12 weeks of supplementation The blood samples will be taken for Clock Genes expression at fasting and after meal challenge every hour until 4 hours


Secondary Outcome Measures :
  1. Fasting HbA1c [ Time Frame: Fasting blood levels will be taken at baseline and after 12 weeks of supplementation with RGC or placebo ]
    In all 40 subjects, fasting blood levels for HbA1c, will be measured at baseline and after 12 weeks of supplementation treatment with RGC n=20 or placebo n=20


Other Outcome Measures:
  1. fasting and postprandial glucose, Insulin, GLP-1, asymmetric dimethylarginine (ADMA),and lipid plasma levels [ Time Frame: The samples will be taken at fasting and every hours until 4 hours after meal challenge, in to occasions at baseline and after 12 week of supplementation with RGC or Placebo ]
    In all 40 subjects the effects of RGC ingestion or placebo will be evaluated in at baseline and after 12 weeks of supplementation with RGC or placebo. The blood samples will be taken at fasting and every hour up to 4 hours after meal challenge for quantification of Glucose, Insulin, glucagon-like peptide-1 (GLP-1), ADMA and for lipid plasma levels.



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Type 2 diabetes patients
  2. HbA1C > 7 %
  3. Duration of diabetes: 0.5 to 20 years
  4. Subjects ≥ 30 and ≤70 years of age
  5. BMI: 22 to 35 kg/m2
  6. Fasting Triglyceride serum level ≥ 150 mg/dl
  7. All oral antidiabetic treatments will be allowed, with the exception of thiazolidinediones (glitazones).i.e. pioglitazone (Actos) or rosiglitazone (Avandia). Insulin and no GLP-1 analogs will not be allowed.
  8. Normal liver and kidney function
  9. Normal thyroid function
  10. Acceptable health beside diabetes based on interview, medical history, physical examination, and laboratory tests
  11. Willingness to avoid the use of over-the-counter medications, herbs, or supplements throughout the entire study.
  12. Willingness to avoid ingestion of any foods containing peanuts, bilberries, blueberries, cranberries, strawberries, raspberries, grapes, grape juice, cocoa powder, dark chocolate, and red wine throughout the entire study
  13. Stable physical activity pattern during the three months immediately preceding study
  14. Usually wakes up between 06:00 and 07:00 and goes to sleep between 22:00 and 24:00.
  15. No shift work within 5 years of the study
  16. Did not cross time zones within 1 month of the study
  17. Read and understood the informed consent form and signed it voluntarily

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Exclusion Criteria:

  1. Type 1 diabetes
  2. Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease
  3. Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)
  4. Pregnancy or lactation
  5. Illicit drug abuse or alcoholism
  6. Treatment with thiazolidinediones (glitazones).i.e. pioglitazone (Actos) or rosiglitazone (Avandia).
  7. Insulin and or GLP-1 analogs will not be allowed.
  8. Anti hyperlipidemic treatment with fibrates. Statins will be allowed
  9. Subjects taking anoretic drugs during the month immediately prior to study
  10. Subjects on steroid treatment
  11. Those with major illnesses, liver, heart, kidney, lung, infectious, neurological, psychiatric, immunological or neoplastic diseases,
  12. Those with eating disorders
  13. Known hypersensitivity to grapes, soy and/or casein
  14. Subjects after bariatric surgery, will be excluded

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938521


Locations
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Israel
Daniela Jakubowicz MD
Holon,, Tel Aviv, Israel, 58100
Sponsors and Collaborators
Tel Aviv University
Wolfson Medical Center
Investigators
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Principal Investigator: Daniela Jakubowicz, MD Diabetes Unit E. Wolfson Medical Center. Tel Aviv University

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Responsible Party: Daniela Jakubowicz, Prof. Daniela Jakubowicz MD, Tel Aviv University
ClinicalTrials.gov Identifier: NCT01938521     History of Changes
Other Study ID Numbers: 0107-13-WOMC
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018

Keywords provided by Daniela Jakubowicz, Tel Aviv University:
Red Grape Cells powder (RGC)
Placebo (PLA)

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases