ObesityNCT01518764
The Effects of Red Wine Polyphenols on Microvascular Dysfunction
A study testing Red Wine Polyphenols 600mg/day in people with Obesity, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
Rationale: Epidemiological studies have shown that consumption of alcoholic beverages, red wine in particular, is associated with less cardiovascular mortality. In addition, there are reported beneficial effects of red wine on components of the metabolic syndrome, arguably the most menacing cardiometabolic condition… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Red Wine Polyphenols 600mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2012to Nov 2014
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian
- age 18-60 years
- obese (BMI >30)
Who cannot join
- cardiovascular disease
- smoking
- diabetes mellitus
- recent history (<12 months) of high alcohol use > 4 U/day
- use of medication potentially affection insulin sensitivity or microvascular function
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Rationale:
Epidemiological studies have shown that consumption of alcoholic beverages, red wine in particular, is associated with less cardiovascular mortality. In addition, there are reported beneficial effects of red wine on components of the metabolic syndrome, arguably the most menacing cardiometabolic condition facing us due to the unfolding obesity epidemic. Beneficial effects have also been reported with other polyphenol-rich food stuff, such as cocoa and green tea and points to a beneficial effect which does not seem to be dependent on the alcohol content of red wine. Experimental studies with mixed or separate Red Wine Polyphenols (RWPs) (i.e. without alcohol) have shown beneficial effects on cardiometabolic parameters associated with obesity. Most research has focused on resveratrol, a specific polyphenol components which is quite specific to red wine and has, at least in animal studies, beneficial effects on insulin sensitivity, insulin secretion, and endothelial function. Moreover, RWPs have shown to improve endothelial NO-mediated relaxation using the same PI3-kinase/Akt pathway as does insulin. However, data in humans are remarkably scarce
Read more
Objective:
To study effects of RWPs on insulin sensitivity, beta-cell function, microvascular function (skin, muscle and cardiac), blood pressure, insulin-mediated microvascular responsiveness.
Study design:
Randomized controlled trial (double blind).
Study population:
Obese (BMI >30); n=30, men or women, aged 18-60 years.
Intervention:
Mixed RWP 600mg/day or matching placebo for a total duration of 8 weeks.
- Conditions
- Obesity
- Being tested
- Red Wine Polyphenols 600mg/day, placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Wine Polyphenols 600mg/dayDietary supplement
Also called Provinols™
placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Red Wine Polyphenols | Experimental | Red Wine Polyphenols 600mg/day (capsules) Receives: Dietary Supplement: Red Wine Polyphenols 600mg/day |
| placebo | Placebo comparator | placebo (capsules) Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin sensitivity as determined by euglycemic clamp tests
Measured: 8 weeks
Secondary outcomes (4)
Molecular mechanisms in muscle tissue
Measured: 8 weeks
Glucose tolerance as assessed by the area under the curve for glucose (AUCgluc) during a standardized meal test
Measured: 8 weeks
microvascular function (baseline and during hyperglycemia)
Measured: 8 weeks
Blood pressure 24 hr measurement
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startMay 2012
- Primary completionNov 2014
- Study completionNov 2014
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 ObesityStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Serne, Amsterdam UMC, location VUmc
- Investigators
- Erik Serne, MD PhD, Principal investigator, VUmc, internal medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518764
- Sponsor's protocol ID
- NL37147.029.11
- Status last verified
- Nov 2014
- First submitted
- 2 Jan 2012
- Last updated
- 25 Nov 2014
- Results posted
- No
Publications
Woerdeman J, Del Rio D, Calani L, Eringa EC, Smulders YM, Serne EH. Red wine polyphenols do not improve obesity-associated insulin resistance: A randomized controlled trial. Diabetes Obes Metab. 2018 Jan;20(1):206-210. doi: 10.1111/dom.13044. Epub 2017 Aug 14.
PubMed 28643477
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Red Wine Polyphenols on Microvascular Dysfunction
- ClinicalTrials.gov ID
- NCT01518764
- Acronym / sponsor ID
- NL37147.029.11
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 26 Jan 2012 (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.
Rationale:
Epidemiological studies have shown that consumption of alcoholic beverages, red wine in particular, is associated with less cardiovascular mortality. In addition, there are reported beneficial effects of red wine on components of the metabolic syndrome, arguably the most menacing cardiometabolic condition facing us due to the unfolding obesity epidemic. Beneficial effects have also been reported with other polyphenol-rich food stuff, such as cocoa and green tea and points to a beneficial effect which does not seem to be dependent on the alcohol content of red wine. Experimental studies with mixed or separate Red Wine Polyphenols (RWPs) (i.e. without alcohol) have shown beneficial effects on cardiometabolic parameters associated with obesity. Most research has focused on resveratrol, a specific polyphenol components which is quite specific to red wine and has, at least in animal studies, beneficial effects on insulin sensitivity, insulin secretion, and endothelial function. Moreover, RWPs have shown to improve endothelial NO-mediated relaxation using the same PI3-kinase/Akt pathway as does insulin. However, data in humans are remarkably scarce
Objective:
To study effects of RWPs on insulin sensitivity, beta-cell function, microvascular function (skin, muscle and cardiac), blood pressure, insulin-mediated microvascular responsiveness.
Study design:
Randomized controlled trial (double blind).
Study population:
Obese (BMI >30); n=30, men or women, aged 18-60 years.
Intervention:
Mixed RWP 600mg/day or matching placebo for a total duration of 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Red Wine Polyphenols | Experimental | Dietary Supplement: Red Wine Polyphenols 600mg/dayRed Wine Polyphenols 600mg/day (capsules) |
| placebo | Placebo comparator | Dietary Supplement: placeboplacebo (capsules) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Caucasian
- age 18-60 years
- obese (BMI >30)
Key exclusion criteria (6 listed)
- cardiovascular disease
- smoking
- diabetes mellitus
- recent history (<12 months) of high alcohol use > 4 U/day
- use of medication potentially affection insulin sensitivity or microvascular function
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 Wine Polyphenols 600mg/dayAlso: Provinols™ | Dietary supplement | Red Wine Polyphenols |
| placebo | Dietary supplement | placebo |
Primary outcome
insulin sensitivity as determined by euglycemic clamp tests
Time frame: 8 weeks
4 secondary outcomes
Molecular mechanisms in muscle tissue
Time frame: 8 weeks
Glucose tolerance as assessed by the area under the curve for glucose (AUCgluc) during a standardized meal test
Time frame: 8 weeks
microvascular function (baseline and during hyperglycemia)
Time frame: 8 weeks
Blood pressure 24 hr measurement
Time frame: 8 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 25 Nov 2014.
- Derived from this study: PubMed 28643477Woerdeman J, Del Rio D, Calani L, Eringa EC, Smulders YM, Serne EH. Red wine polyphenols do not improve obesity-associated insulin resistance: A randomized controlled trial. Diabetes Obes Metab. 2018 Jan;20(1):206-210. doi: 10.1111/dom.13044. Epub 2017 Aug 14.
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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.
Erik Serne, MD PhD principal investigator
VUmc, internal medicine
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 Wine Polyphenols 600mg/day in people with Obesity, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 3 inclusion and 6 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 25 Nov 2014. 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 Netherlands. 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?
insulin sensitivity as determined by euglycemic clamp tests (time frame: 8 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 NCT01518764, 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 25 Nov 2014.