CClinicalTrials.gg
CompletedNCT02409537RWTACUpdated Apr 7, 2015

Effects of Dietary Antioxidants to Prevent Cardiovascular Disease

A Phase 2 interventional study of red wine and resveratrol in Hypercholesterolemia and Healthy, sponsored by Aeromedical Center, Thessaloniki. Completed. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-07.

Sponsored by Aeromedical Center, Thessaloniki · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
37
Allocation
Non-randomized
Ages
20 Years to 70 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Hypercholesterolemia
  • Healthy

Keywords

  • Asymptomatic hypercholesterolemia,
  • cardiovascular risk,
  • total antioxidant capacity
  • red wine polyphenol content
  • vitamin E.
  • resveratrol
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's enrollment of 37 is below the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

This is the only study on the registry with Aeromedical Center, Thessaloniki as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Active comparator
    non cholesterolemic individuals

    Individuals 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.

    Dietary Supplement: red wine · Dietary Supplement: resveratrol · Other: placebo

  • Active comparator
    Asymptomatic Hypercholesterolemics

    individuals 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.

    Dietary Supplement: red wine · Dietary Supplement: resveratrol · Other: placebo

Interventions

  • Dietary supplementred wine

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

  • Dietary supplementresveratrol

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

  • Otherplacebo

    the individuals were given placebo for 1 month

06

What researchers measure

Primary outcomes

  1. Total antioxidant activity (TAC)

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 6 months

Secondary outcomes

  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

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02409537
Lead sponsor
Aeromedical Center, Thessaloniki
Responsible party
Christina Apostolidou (Aristotle University of Thessaloniki, School of engineering, Faculty of Chemical Engineering, Division of technology laboratory of food and process engineering, Aeromedical Center, Thessaloniki) — Principal investigator
First posted
Apr 7, 2015
Start date
Mar 2013
Primary completion
Mar 2014
Completion
Mar 2015
Last update
Apr 7, 2015

Study contacts

Konstantinos Adamopoulos, PhD
study director · Aristotle University of Thessaloniki, School of engineering, Faculty of Chemical Engineering, Division of technology laboratory of food and process engineering,
Christina Apostolidou, MS
principal investigator · Aristotle University of Thessaloniki, School of engineering, Faculty of Chemical Engineering, Division of technology laboratory of food and process engineering,

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion