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Effects of Dietary Antioxidants to Prevent Cardiovascular Disease (RWTAC)

Primary Purpose

Hypercholesterolemia, Healthy

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
red wine
resveratrol
placebo
Sponsored by
Aeromedical Center, Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypercholesterolemia focused on measuring Asymptomatic hypercholesterolemia,, cardiovascular risk,, total antioxidant capacity, red wine polyphenol content, vitamin E., resveratrol

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    non cholesterolemic individuals

    Asymptomatic Hypercholesterolemics

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Total antioxidant activity (TAC)
    TAC was measured after 1 month of red wine consumption, resveratrol and placebo and wash out periods in between
    Vitamin E
    Vitamin E was measured after 1 month of red wine consumption, resveratrol and placebo and wash out periods in between
    Total Cholesterol
    Total cholesterol was measured after 1 month of red wine consumption, resveratrol and placebo and wash out periods in between
    LDL/HDL
    The ratio LDL/HDL was measured after 1 month of red wine consumption, resveratrol and placebo and wash out periods in between

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    March 29, 2015
    Last Updated
    April 1, 2015
    Sponsor
    Aeromedical Center, Thessaloniki
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02409537
    Brief Title
    Effects of Dietary Antioxidants to Prevent Cardiovascular Disease
    Acronym
    RWTAC
    Official Title
    Cardiovascular Risk and Benefits From Antioxidant Dietary Intervention With Red Wine in Asymptomatic Hypercholesterolemics
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2013 (undefined)
    Primary Completion Date
    March 2014 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aeromedical Center, Thessaloniki

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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..
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolemia, Healthy
    Keywords
    Asymptomatic hypercholesterolemia,, cardiovascular risk,, total antioxidant capacity, red wine polyphenol content, vitamin E., resveratrol

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    37 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    non cholesterolemic individuals
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Asymptomatic Hypercholesterolemics
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    red wine
    Intervention Description
    the individuals were given red wine to consume for 1 month then a wash out period of 1 month
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    resveratrol
    Intervention Description
    the individuals were given resveratrol for 1 month and then 1 month wash out period
    Intervention Type
    Other
    Intervention Name(s)
    placebo
    Intervention Description
    the individuals were given placebo for 1 month
    Primary Outcome Measure Information:
    Title
    Total antioxidant activity (TAC)
    Description
    TAC was measured after 1 month of red wine consumption, resveratrol and placebo and wash out periods in between
    Time Frame
    6 months
    Title
    Vitamin E
    Description
    Vitamin E was measured after 1 month of red wine consumption, resveratrol and placebo and wash out periods in between
    Time Frame
    6 months
    Title
    Total Cholesterol
    Description
    Total cholesterol was measured after 1 month of red wine consumption, resveratrol and placebo and wash out periods in between
    Time Frame
    6 months
    Title
    LDL/HDL
    Description
    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 Outcome Measure Information:
    Title
    Vitamin E/ Total Cholesterol
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy volunteers with normal or high cholesterol level with no cardiovascular disease 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Konstantinos Adamopoulos, PhD
    Organizational Affiliation
    Aristotle University of Thessaloniki, School of engineering, Faculty of Chemical Engineering, Division of technology laboratory of food and process engineering,
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Christina Apostolidou, MS
    Organizational Affiliation
    Aristotle University of Thessaloniki, School of engineering, Faculty of Chemical Engineering, Division of technology laboratory of food and process engineering,
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23174266
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    20428452
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    25332827
    Citation
    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.
    Results Reference
    result

    Learn more about this trial

    Effects of Dietary Antioxidants to Prevent Cardiovascular Disease

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