Effects of Dietary Antioxidants to Prevent Cardiovascular Disease

NCT ID: NCT02409537

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-03-31

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.

Conditions

Hypercholesterolemia; Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

red wine

Intervention Type: DIETARY_SUPPLEMENT

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

resveratrol

Intervention Type: DIETARY_SUPPLEMENT

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

placebo

Intervention Type: OTHER

the individuals were given placebo for 1 month

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.

Group Type: ACTIVE_COMPARATOR

red wine

Intervention Type: DIETARY_SUPPLEMENT

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

resveratrol

Intervention Type: DIETARY_SUPPLEMENT

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

placebo

Intervention Type: OTHER

the individuals were given placebo for 1 month

Interventions

red wine

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

Intervention Type: DIETARY_SUPPLEMENT

resveratrol

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

Intervention Type: DIETARY_SUPPLEMENT

placebo

the individuals were given placebo for 1 month

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aeromedical Center, Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

Christina Apostolidou

Aristotle University of Thessaloniki, School of engineering, Faculty of Chemical Engineering, Division of technology laboratory of food and process engineering

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Konstantinos Adamopoulos, PhD

Role: 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

Role: PRINCIPAL_INVESTIGATOR

Aristotle University of Thessaloniki, School of engineering, Faculty of Chemical Engineering, Division of technology laboratory of food and process engineering,

References

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.

Reference Type: RESULT

PMID: 23174266 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20428452 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25332827 (View on PubMed)

Other Identifiers

0011

Identifier Type: -

Identifier Source: org_study_id