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

NCT01938521 | Completed DMC

• 1 other identifier: 0107-13-WOMC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 .

Conditions

Type 2 Diabetes

Keywords

Red Grape Cells powder (RGC); Placebo (PLA)

Outcome Measures

Primary Outcomes (1)

• Fasting and postprandial Clock Genes expression in peripheral blood cells (PBC)

  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

  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 .

Secondary Outcomes (1)

• Fasting HbA1c

  Fasting blood levels will be taken at baseline and after 12 weeks of supplementation with RGC or placebo

Other Outcomes (1)

• fasting and postprandial glucose, Insulin, GLP-1, asymmetric dimethylarginine (ADMA),and lipid plasma levels

  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

Study Arms (2)

Red Grape Cells (RGC)

EXPERIMENTAL

Red Grape Cells (RGC) 1000 mg powder once daily by mouth for three month

Dietary Supplement: Red Grape Cells (RGC)

Placebo (for Red Grape Cells (RGC))

PLACEBO COMPARATOR

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))

Interventions

Red Grape Cells (RGC) DIETARY_SUPPLEMENT

Red Grape Cells (RGC) 1000 mg powder once daily by mouth for three month

Also known as: RGC

Red Grape Cells (RGC)

Placebo (for Red Grape Cells (RGC)) DIETARY_SUPPLEMENT

Placebo (for Red Grape Cells (RGC)) powder manufactured to mimic Red Grape Cells (RGC) 1000 mg powder

Also known as: RGC Placebo

Placebo (for Red Grape Cells (RGC))

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes patients
• HbA1C \> 7 %
• Duration of diabetes: 0.5 to 20 years
• Subjects ≥ 30 and ≤70 years of age
• BMI: 22 to 35 kg/m2
• Fasting Triglyceride serum level ≥ 150 mg/dl
• 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.
• Normal liver and kidney function
• Normal thyroid function
• Acceptable health beside diabetes based on interview, medical history, physical examination, and laboratory tests
• Willingness to avoid the use of over-the-counter medications, herbs, or supplements throughout the entire study.
• 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
• Stable physical activity pattern during the three months immediately preceding study
• Usually wakes up between 06:00 and 07:00 and goes to sleep between 22:00 and 24:00.
• No shift work within 5 years of the study

You may not qualify if:

• Type 1 diabetes
• Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease
• 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)
• Pregnancy or lactation
• Illicit drug abuse or alcoholism
• Treatment with thiazolidinediones (glitazones).i.e. pioglitazone (Actos) or rosiglitazone (Avandia).
• Insulin and or GLP-1 analogs will not be allowed.
• Anti hyperlipidemic treatment with fibrates. Statins will be allowed
• Subjects taking anoretic drugs during the month immediately prior to study
• Subjects on steroid treatment
• Those with major illnesses, liver, heart, kidney, lung, infectious, neurological, psychiatric, immunological or neoplastic diseases,
• Those with eating disorders
• Known hypersensitivity to grapes, soy and/or casein
• Subjects after bariatric surgery, will be excluded

Sponsors & Collaborators

• Tel Aviv University: lead
• Wolfson Medical Center: collaborator

Study Sites (1)

Daniela Jakubowicz MD

Holon, Tel Aviv, 58100, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Daniela Jakubowicz, MD

  Diabetes Unit E. Wolfson Medical Center. Tel Aviv University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Daniela Jakubowicz MD

Study Record Dates

• First Submitted: September 1, 2013
• First Posted: September 10, 2013
• Study Start: September 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: November 1, 2017
• Last Updated: August 28, 2018

Record last verified: 2018-08

Locations

IL (1)