Effects of Dietary Antioxidants to Prevent Cardiovascular Disease

NCT02409537 | Completed Phase 2 DMC

• 1 other identifier: 0011
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

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..

Conditions

Hypercholesterolemia; Healthy

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Total antioxidant activity (TAC)

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

  6 months

• Vitamin E

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

  6 months

• Total Cholesterol

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

  6 months

• LDL/HDL

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

  6 months

Secondary Outcomes (1)

• Vitamin E/ Total Cholesterol

  6 months

Study Arms (2)

non cholesterolemic individuals

ACTIVE COMPARATOR

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

Asymptomatic Hypercholesterolemics

ACTIVE COMPARATOR

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

red wine DIETARY_SUPPLEMENT

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

Asymptomatic Hypercholesterolemics; non cholesterolemic individuals

resveratrol DIETARY_SUPPLEMENT

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

Asymptomatic Hypercholesterolemics; non cholesterolemic individuals

placebo OTHER

the individuals were given placebo for 1 month

Asymptomatic Hypercholesterolemics; non cholesterolemic individuals

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aeromedical Center, Thessaloniki: lead

Related Publications (3)

• 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.

  PMID: 23174266 RESULT

• 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.

  PMID: 20428452 RESULT

• 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.

  PMID: 25332827 RESULT

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Konstantinos Adamopoulos, PhD

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

  STUDY DIRECTOR

• Christina Apostolidou, MS

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Aristotle University of Thessaloniki, School of engineering, Faculty of Chemical Engineering, Division of technology laboratory of food and process engineering

Study Record Dates

• First Submitted: March 29, 2015
• First Posted: April 7, 2015
• Study Start: March 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2015
• Last Updated: April 7, 2015

Record last verified: 2015-04