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Effect of anthocyanin-rich food intake on reduction of cardiovascular risk factors

In vivo study of the effects of anthocyanin (ACN) and polyphenol-rich foods on the modulation of biomarkers related to oxidative stress

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN59129089
Enrollment
20
Registered
2014-06-05
Start date
2013-05-01
Completion date
Unknown
Last updated
2021-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxidative stress and /or risk factors for cardiovascular disease Circulatory System

Interventions

Study 1- Acute study: Participants are randomized in a cross-over design and receive blueberry (i.e. fresh whole berries or juice, providing at least 300mg of ACNs) or placebo (i.e. drink/food without

Sponsors

University of Milan (Università degli Studi di Milano) (Italy)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy men/women smokers (20-35 years of age) 2. Moderate smoking (about 10-15 cigarette/day) 3. Moderate physical activity (25-30 min per day of brisk walk or jog) 4. Moderate alcohol consumption (up to 14 drinks per week)

Exclusion criteria

Exclusion criteria: 1. Individuals with hypertension (systolic blood pressure > 140 mm Hg and/or diastolic blood pressure > 90 mm Hg), hyperglycemia (> 180 mmol/L), hypertriglyceridemia (=1.69 mmol/L) and hypercholesterolemia (=5.17 mmol/L), low HDL cholesterol (25) 2. History of cardiovascular, coronary, diabetes, hepatic, renal, or gastrointestinal diseases, traumas of the arms or hand, fingers, atopic dermatitis, thyroid disturbance, depression, anxiety, palpitations and chronic backache 3. Use of any drugs, supplements, specific prebiotics or prebiotics or medications at least one month before the beginning of the experiment 4. Volunteers who did not eat fruits and vegetables 5. Difference in dietary habits in particular for food rich in antioxidant compounds: high (> 5 portions/day) or low (<2 portions/day) intake of fruit and vegetables 6. Vegetarian, vegan or macrobiotic

Design outcomes

Primary

MeasureTime frame
1. The reduction of endogenous oxidized DNA bases and the resistance to H2O2-induced DNA damage (evaluated in blood mononuclear cells by Comet assay) 2. Improvement of peripheral vascular function (measured by a non-invasive pletismographic method). The outcomes are measured before and after the blueberry or placebo treatment and at specific time points.

Secondary

MeasureTime frame
The following outcomes are measured before and after the blueberry or placebo treatment for the chronic study, and at specific time points for the acute study (before blueberry/placebo intake and after 2 h, 2 h 30 min, 3 h, 3h 30 min, and 24h). 1. Reduction of endogenous oxidized DNA bases and the resistance to oxidatively-induced DNA damage (evaluated in blood mononuclear cells by Comet assay) 2. Nutritional biomarkers [i.e. ACNs, vitamin C, folate, glutathione (GSH/ GSSG)] 3. Changes in blood pressure (diastolic and systolic blood pressure) and markers of endothelial function [i.e., soluble vascular adhesion molecule concentration (sVCAM-1), vascular endothelial growth factor (VEGF), total nitric oxide (NO)] 4. Changes in glucose and lipid profile [triglycerides, total cholesterol, high density lipoprotein (HDL)-cholesterol, low density lipoprotein (LDL)-cholesterol] 5. Changes in markers of inflammation [i.e., C-reactive protein (CRP), interleukin-8 (IL-8)]

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026