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HypercholesterolemiaPhase 2RWTACNCT02409537

Effects of Dietary Antioxidants to Prevent Cardiovascular Disease

A Phase 2 study testing red wine and resveratrol in people with Hypercholesterolemia and Healthy, run by Aeromedical Center, Thessaloniki.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background \& Aims: The role of red wine in cardiovascular risk prevention has been documented by several epidemiological studies in patients and normocholesterolemic healthy individuals. Read more about this study

Who is it for?
Ages 20 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Hypercholesterolemia, Healthy
What is being tested?
red wine and resveratrol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
37 participants
Where
No sites listed yet
Study dates
Mar 2013to Mar 2015
Phase
Phase 2
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 20 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy volunteers with normal or high cholesterol level with no cardiovascular disease

Who cannot join

  • documented dyslipidemia (abnormal level of fat or cholesterol (very high or very low),
  • chronic liver disease, malnutrition, neoplastic or acute infectious diseases,
  • habitual use of vitamin supplements.

About this study

Official title: Cardiovascular Risk and Benefits From Antioxidant Dietary Intervention With Red Wine in Asymptomatic Hypercholesterolemics

Background \& Aims: The role of red wine in cardiovascular risk prevention has been documented by several epidemiological studies in patients and normocholesterolemic healthy individuals. However, it is unclear whether hypercholesterolemic individuals free of cardiovascular disease would equally benefit from moderate red wine consumption to prevent atherosclerosis and the development of cardiovascular disease.

Methods: Forty (40) healthy volunteers males and females were recruited, divided into 2 age-adjusted groups according to their total cholesterol levels; in asymptomatic hypercholesterolemics (AHC ), and normocholesterolemics (NC ). Total Antioxidant Capacity (TAC ), Lipid profile, Vitamin E, and cardiovascular risk indexes ( LDL /HDL and Vitamin E/TC ) were evaluated in the blood serum of all subjects prior to and 1 month after once daily red wine consumption as well as prior to and after being given a placebo drink following a 1 month wash out period and resveratrol for 1 month after wash out period..

Read the detailed description

Study design and measurements This study is a cross-over field trial. Participants were asked to consume a specific variety of red wine "tannat" daily in their diet for one month. After a wash-out period of one month, the same participants were asked to consume a placebo drink daily for another month. Quantitative measurements of blood lipids, vitamin E, and Total Antioxidant Capacity before and after consumption of wine and placebo were measured. The study aimed to investigate whether consumption of red wine is associated with any changes in the levels of blood lipids, vitamin E, and Total Antioxidant Capacity and whether such changes - if any -equally occur in hypercholesterolemic individuals.

Participants were advised to abstain from consuming antioxidant supplements, antioxidant-rich foods (including deep-colored fruits and vegetables such as berries, tomatoes, carrots, broccoli, apples and plums, green tea, caffeine and chocolate), caffeine and alcohol 2 weeks prior to the beginning of initial measurements and during the 3-month experimental period. Participants (occasional alcohol drinkers) included in the study received no monetary compensation. According to the U.S. Department of Agriculture 2010 Dietary Guidelines, moderate drinking corresponds to one drink per day for women and two for men14. Consequently, female subjects were given 5 bottles of red wine for 1 month (1 glass per day), and male subjects were given 10 bottles (2 glasses/per day) and instructed to report any side effects or failure to participate. The single grape variety of Tannat, from a location in Northern Greece, was selected among several varieties of red wine for its content in phenolic compounds and high antioxidant gradient when tested in vitro. Participants were encouraged to not alter their dietary habits or physical activity level during the study. To verify their compliance with the instructions provided, we interviewed them before and after the experiment, and we also measured the quantity of wine used. One day prior to the beginning of the intervention, participants underwent physical and routine biochemical examinations and completed two questionnaires, one related to their health status and the other to their characteristics. To confirm protocol adherence, a team of colleagues contacted the participants by telephone every 2nd day and they visited the clinic to obtain 1 bottle of wine and answered a questionnaire regarding their adherence with the protocol requirements.

For each subject, measurements of serum TAC and vitamin E were performed pre and post 1 month of red wine ingestion and pre and post placebo drink ingestion after a 1 month wash out period. For vitamin E measurements, fasting subjects were requested to abstain from alcohol for 24 hours prior to the blood draw. Serum levels of Total Cholesterol (TC), triglycerides (TG), HDL-cholesterol, and LDL-cholesterol were also measured by enzymatic methods. For serum HDL-cholesterol levels, fasting blood was collected in tubes with a clot activator and was determined enzymatically.

For the assessment of cardiovascular risk, pre and post red wine consumption ratios (LDL/HDL-cholesterol and vitamin E/TC) were calculated. TG/HDL-cholesterol, a marker for insulin resistance, was also proposed as a surrogate marker of cardiovascular risk assessment. TC/HDL and LDL/HDL are also considered to be strong predictors of the degree of clinical benefit from lipid-lowering interventions.

Being tested
red wine, resveratrol, placebo
Keywords
Asymptomatic hypercholesterolemia,, cardiovascular risk,, total antioxidant capacity, red wine polyphenol content, vitamin E., resveratrol
Medical subject headings
Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • red wineDietary supplement

    the individuals were given red wine to consume for 1 month then a wash out period of 1 month

  • resveratrolDietary supplement

    the individuals were given resveratrol for 1 month and then 1 month wash out period

  • placeboOther

    the individuals were given placebo for 1 month

Study groups in NCT02409537
Study groupRoleWhat they receive
non cholesterolemic individualsActive comparatorIndividuals with normal cholesterol levels will consume red wine for 1 month. There will be 1 month of wash out period. After 1 month of wash out period resveratrol will be consumed for 1 month and finally after 1 month wash out period placebo will be administered for 1 month.
Receives: Dietary Supplement: red wine; Dietary Supplement: resveratrol; Other: placebo
Asymptomatic HypercholesterolemicsActive comparatorindividuals with high levels of cholesterol with no cardiovascular disease Those individuals will consume red wine for 1 month. There will be 1 month of wash out period. After 1 month of wash out period resveratrol will be consumed for 1 month and finally after 1 month wash out period placebo will be administered for 1 month.
Receives: Dietary Supplement: red wine; Dietary Supplement: resveratrol; Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total antioxidant activity (TAC)

    TAC was measured after 1 month of red wine consumption, resveratrol and placebo and wash out periods in between

    Measured: 6 months

  2. Vitamin E

    Vitamin E was measured after 1 month of red wine consumption, resveratrol and placebo and wash out periods in between

    Measured: 6 months

  3. Total Cholesterol

    Total cholesterol was measured after 1 month of red wine consumption, resveratrol and placebo and wash out periods in between

    Measured: 6 months

  4. LDL/HDL

    The ratio LDL/HDL was measured after 1 month of red wine consumption, resveratrol and placebo and wash out periods in between

    Measured: 6 months

Secondary outcomes (1)
  1. Vitamin E/ Total Cholesterol

    The ratio Vitamin E/ Total Cholesterol was measured after 1 month of red wine consumption, resveratrol and placebo and wash out periods in between

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2015 (estimated)
  2. Study startMar 2013
  3. Primary completionMar 2014
  4. Study completionMar 2015

Resources

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 2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02409537
Sponsor's protocol ID
0011
Acronym
RWTAC
Status last verified
Apr 2015
First submitted
29 Mar 2015
Last updated
7 Apr 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Quinones M, Miguel M, Aleixandre A. Beneficial effects of polyphenols on cardiovascular disease. Pharmacol Res. 2013 Feb;68(1):125-31. doi: 10.1016/j.phrs.2012.10.018. Epub 2012 Nov 19.

    PubMed 23174266
  • Zenebe W, Pechanova O, Bernatova I. Protective effects of red wine polyphenolic compounds on the cardiovascular system. Exp Clin Cardiol. 2001 Fall;6(3):153-8.

    PubMed 20428452
  • Roerecke M, Rehm J. Chronic heavy drinking and ischaemic heart disease: a systematic review and meta-analysis. Open Heart. 2014 Aug 6;1(1):e000135. doi: 10.1136/openhrt-2014-000135. eCollection 2014.

    PubMed 25332827

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing red wine and resveratrol in people with Hypercholesterolemia and Healthy, run by Aeromedical Center, Thessaloniki.

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 1 inclusion and 3 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 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Total antioxidant activity (TAC) (time frame: 6 months). The study lists 4 primary outcomes in all. 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 NCT02409537, which also lists 3 linked publications.

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 7 Apr 2015.

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