Type 2 DiabetesRGC-T2DNCT01938521
Effects of Red Grape Cells (RGC) Powder in Type 2 Diabetics
A study testing Red Grape Cells (RGC) in people with Type 2 Diabetes, run by Tel Aviv University at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Red Grape Cells (RGC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2013to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Did not cross time zones within 1 month of the study
- Read and understood the informed consent form and signed it voluntarily
- -
Who cannot join
- 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).
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- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
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
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 .
Read the 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
- Conditions
- Type 2 Diabetes
- Being tested
- Red Grape Cells (RGC), Placebo (for Red Grape Cells (RGC))
- Keywords
- Red Grape Cells powder (RGC), Placebo (PLA)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Grape Cells (RGC)Dietary supplement
Also called RGC
Red Grape Cells (RGC) 1000 mg powder once daily by mouth for three month
Placebo (for Red Grape Cells (RGC))Dietary supplement
Also called RGC Placebo
Placebo (for Red Grape Cells (RGC)) powder manufactured to mimic Red Grape Cells (RGC) 1000 mg powder
| Study group | Role | What they receive |
|---|---|---|
| Red Grape Cells (RGC) | Experimental | Red Grape Cells (RGC) 1000 mg powder once daily by mouth for three month Receives: 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 Receives: Dietary Supplement: Placebo (for Red Grape Cells (RGC)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: Fasting blood levels will be taken at baseline and after 12 weeks of supplementation with RGC or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionFeb 2014
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Collaborators
- Wolfson Medical Center
- Responsible party
- Principal investigator, Daniela Jakubowicz, Tel Aviv University
- Investigators
- Daniela Jakubowicz, MD, Principal investigator, Diabetes Unit E. Wolfson Medical Center. Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938521
- Sponsor's protocol ID
- 0107-13-WOMC
- Acronym
- RGC-T2D
- Status last verified
- Aug 2018
- First submitted
- 1 Sep 2013
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01938521
- Acronym / sponsor ID
- RGC-T2D / 0107-13-WOMC
- Conditions
- Type 2 Diabetes
- Keywords
- Red Grape Cells powder (RGC), Placebo (PLA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Collaborators
- Wolfson Medical Center
- Study start
- Sep 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 10 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Red Grape Cells (RGC) | Experimental | Dietary Supplement: Red Grape Cells (RGC)Red Grape Cells (RGC) 1000 mg powder once daily by mouth for three month |
| Placebo (for Red Grape Cells (RGC)) | Placebo comparator | Dietary Supplement: 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 |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red Grape Cells (RGC)Also: RGCRed 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))Also: RGC PlaceboPlacebo (for Red Grape Cells (RGC)) powder manufactured to mimic Red Grape Cells (RGC) 1000 mg powder | Dietary supplement | Placebo (for Red Grape Cells (RGC)) |
Primary outcome
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
1 secondary outcome
Fasting HbA1c
Time frame: Fasting blood levels will be taken at baseline and after 12 weeks of supplementation with RGC or placebo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela Jakubowicz, MD principal investigator
Diabetes Unit E. Wolfson Medical Center. Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red Grape Cells (RGC) in people with Type 2 Diabetes, run by Tel Aviv University at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.