Healthy VolunteersPOLYOXRESISTNCT01478841
Polyphenols and Insulin Resistance
A study testing polyphenol in people with Healthy Volunteers and Insulin Resistance, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Diet and nutrition play an essential role in the development and the clinical expression of the most common health problems. Overeating and obesity induce oxidative stress, which has been proposed to be a pathogenic mechanism leading to insulin resistance, type 2 diabetes (T2D) and associated cardiovascular… Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Insulin Resistance, Type 2 Diabetes (T2D)
- What is being tested?
- polyphenol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2008to Jan 2012
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Absence of anti HIV or anti hepatitis C antibodies and of HBS antigen.
- Acceptable biological assessment of the hepatic and renal functions (γGT, ALAT, ASAT < 3 times the normal value and serum creatinine <150 micromol/l).
- Age between 30 and 55 years.
- Fasting plasma glucose <110 mg/dl and absence of any anti-diabetic treatment
- No regular physical activity (Voorips index < 9)
- Absence of any drug treatment in progress and during the last 2 months
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- Subjects with at least one 1st degree relative with T2D and with a body mass index between 25 and 35 kg/m² and a waist measurement >94 cm for males, and >80 cm for females.
- Normal ionogram (sodium 135 - 145 mmol/l, potassium 3,5 - 4,5 mmol/l).
- Normal ferritin level (75 - 300 ng/ml)
- hs-CRP <8 mg/l.
- Absence of arterial hypertension (systolic pressure <140 mmHg and diastolic pressure <90 mmHg).
- Non smoker or former smoker (quit smoking >1 year).
- Alcohol consumption <30 g/day.
Who cannot join
- Hyperthermia (T°>38°c)
- Subject deprived of freedom by a court or administrative order
- Major protected by the law
- Subject who is in a period of relative exclusion due to his/her participation to another protocol or for whom the annual maximum amount of allowances of 3 811.23 € is reached.
- Subject who has been treated with anti-coagulants, anti-inflammatory drugs, b-blockers or insulin during the last month.
- Subject who cannot be subjected to muscle biopsy.
- Allergy to the anaesthetic
- Woman in age to procreate and not taking any oral or intra-uterine contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: INFLUENCE OF POLYPHENOLS ON OXIDATIVE STRESS IN HEALTHY INDIVIDUALS WITH HIGH METABOLISM RISK: RELATIONSHIP WITH THE MECHANISMS OF INSULIN RESISTANCE
Diet and nutrition play an essential role in the development and the clinical expression of the most common health problems. Overeating and obesity induce oxidative stress, which has been proposed to be a pathogenic mechanism leading to insulin resistance, type 2 diabetes (T2D) and associated cardiovascular complications. The main objective of the proposed research is to evaluate the beneficial effects of polyphenolic compounds derived from red grape marc extracts on the cascade of events leading from overeating to oxidative stress and insulin resistance. For that, we will study free radicals production, inflammatory markers, adipokines, mitochondrial function, insulin sensitivity and energy substrate utilization in healthy volunteers at risk for insulin resistance and T2D (1st degree relatives of T2D patients with associated overweight). These volunteers will be randomized between a placebo and a polyphenol group for 9 weeks. The demonstration of the beneficial effects of polyphenols will be sensitized by high-fructose feeding for the last 6 days of the protocol.
- Being tested
- polyphenol, placebo
- Keywords
- insulin resistance, type 2 diabetes (T2D), cardiovascular complications, polyphenolic compounds derived from red grape marc extracts, oxidative stress
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyphenolDrug
2 capsules of 0.5 gram to be taken at the beginning of breakfast and dinner (2g/day) fructose : dose of 3 g/kg/day from D57 to D62 in the form of a 20% solution taken during the three main meals
placeboDrug
2 capsules of 0.5 gram to be taken at the beginning of breakfast and dinner (2g/day) fructose : dose of 3 g/kg/day from D57 to D62 in the form of a 20% solution taken during the three main meals
| Study group | Role | What they receive |
|---|---|---|
| Polyphenols | Experimental | 9 weeks of supplementation with polyphenols(D56) and during the last week supplementation with polyphenols associated with a fructose load during the last 6 days (D63). Receives: Drug: polyphenol |
| placebo | Placebo comparator | 9 weeks of supplementation with placebo (D56) and during the last week supplementation with placebo associated with a fructose load during the last 6 days (D63). Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral insulin-sensitivity
Measured: 6 weeks
Secondary outcomes (1)
biochemical parameters
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startOct 2008
- Primary completionJul 2010
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478841
- Sponsor's protocol ID
- UF8178
- Acronym
- POLYOXRESIST
- Status last verified
- Feb 2012
- First submitted
- 21 Nov 2011
- Last updated
- 13 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hokayem M, Blond E, Vidal H, Lambert K, Meugnier E, Feillet-Coudray C, Coudray C, Pesenti S, Luyton C, Lambert-Porcheron S, Sauvinet V, Fedou C, Brun JF, Rieusset J, Bisbal C, Sultan A, Mercier J, Goudable J, Dupuy AM, Cristol JP, Laville M, Avignon A. Grape polyphenols prevent fructose-induced oxidative stress and insulin resistance in first-degree relatives of type 2 diabetic patients. Diabetes Care. 2013 Jun;36(6):1454-61. doi: 10.2337/dc12-1652. Epub 2012 Dec 28.
PubMed 23275372
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INFLUENCE OF POLYPHENOLS ON OXIDATIVE STRESS IN HEALTHY INDIVIDUALS WITH HIGH METABOLISM RISK: RELATIONSHIP WITH THE MECHANISMS OF INSULIN RESISTANCE
- ClinicalTrials.gov ID
- NCT01478841
- Acronym / sponsor ID
- POLYOXRESIST / UF8178
- Keywords
- insulin resistance, type 2 diabetes (T2D), cardiovascular complications, polyphenolic compounds derived from red grape marc extracts, oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 23 Nov 2011 (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.
Diet and nutrition play an essential role in the development and the clinical expression of the most common health problems. Overeating and obesity induce oxidative stress, which has been proposed to be a pathogenic mechanism leading to insulin resistance, type 2 diabetes (T2D) and associated cardiovascular complications. The main objective of the proposed research is to evaluate the beneficial effects of polyphenolic compounds derived from red grape marc extracts on the cascade of events leading from overeating to oxidative stress and insulin resistance. For that, we will study free radicals production, inflammatory markers, adipokines, mitochondrial function, insulin sensitivity and energy substrate utilization in healthy volunteers at risk for insulin resistance and T2D (1st degree relatives of T2D patients with associated overweight). These volunteers will be randomized between a placebo and a polyphenol group for 9 weeks. The demonstration of the beneficial effects of polyphenols will be sensitized by high-fructose feeding for the last 6 days of the protocol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyphenols | Experimental | Drug: polyphenol9 weeks of supplementation with polyphenols(D56) and during the last week supplementation with polyphenols associated with a fructose load during the last 6 days (D63). |
| placebo | Placebo comparator | Drug: placebo9 weeks of supplementation with placebo (D56) and during the last week supplementation with placebo associated with a fructose load during the last 6 days (D63). |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Absence of anti HIV or anti hepatitis C antibodies and of HBS antigen.
- Acceptable biological assessment of the hepatic and renal functions (γGT, ALAT, ASAT < 3 times the normal value and serum creatinine <150 micromol/l).
- Age between 30 and 55 years.
- Fasting plasma glucose <110 mg/dl and absence of any anti-diabetic treatment
- No regular physical activity (Voorips index < 9)
Key exclusion criteria (8 listed)
- Hyperthermia (T°>38°c)
- Subject deprived of freedom by a court or administrative order
- Major protected by the law
- Subject who is in a period of relative exclusion due to his/her participation to another protocol or for whom the annual maximum amount of allowances of 3 811.23 € is reached.
- Subject who has been treated with anti-coagulants, anti-inflammatory drugs, b-blockers or insulin during the last month.
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 |
|---|---|---|
| polyphenol2 capsules of 0.5 gram to be taken at the beginning of breakfast and dinner (2g/day) fructose : dose of 3 g/kg/day from D57 to D62 in the form of a 20% solution taken during the three main meals | Drug | Polyphenols |
| placebo2 capsules of 0.5 gram to be taken at the beginning of breakfast and dinner (2g/day) fructose : dose of 3 g/kg/day from D57 to D62 in the form of a 20% solution taken during the three main meals | Drug | placebo |
Primary outcome
Peripheral insulin-sensitivity
Time frame: 6 weeks
1 secondary outcome
biochemical parameters
Time frame: 6 weeks
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 13 Feb 2012.
- Derived from this study: PubMed 23275372Hokayem M, Blond E, Vidal H, Lambert K, Meugnier E, Feillet-Coudray C, Coudray C, Pesenti S, Luyton C, Lambert-Porcheron S, Sauvinet V, Fedou C, Brun JF, Rieusset J, Bisbal C, Sultan A, Mercier J, Goudable J, Dupuy AM, Cristol JP, Laville M, Avignon A. Grape polyphenols prevent fructose-induced oxidative stress and insulin resistance in first-degree relatives of type 2 diabetic patients. Diabetes Care. 2013 Jun;36(6):1454-61. doi: 10.2337/dc12-1652. Epub 2012 Dec 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polyphenol in people with Healthy Volunteers and Insulin Resistance, run by University Hospital, Montpellier at 1 site in France.
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 13 inclusion and 8 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 13 Feb 2012. 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 France. 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?
Peripheral insulin-sensitivity (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01478841, which also lists 1 linked publication.
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 13 Feb 2012; AzTrials last refreshed its copy on 30 Oct 2026.