Effects of Cranberry Consumption in Vascular Function in Healthy Individuals

Heinrich-Heine University, Duesseldorf

Status: Completed

Conditions: Healthy Men

Treatments: Dietary Supplement: Cranberry 960; Dietary Supplement: Cranberry deprived supplement; Dietary Supplement: Cranberry 320; Dietary Supplement: Cranberry 640; Dietary Supplement: Cranberry 1600; Dietary Supplement: Cranberry 1280

Study type: Interventional

Funder types: Other

Identifiers

NCT02517775

14-012

Details and patient eligibility

About

Accumulating evidence from epidemiological and human intervention studies indicates that the cardiovascular health benefits of diets rich in fruits and vegetables are (in part) related to their (poly)phenol content. Cranberries are rich in (poly)phenols compounds, in particular anthocyanins, but also phenolic acids. At present, a small number of randomized controlled trials investigating the effects of berry (poly)phenols on validated surrogate markers of cardiovascular disease risk has shown promising results. However, to date, very few human studies have specifically investigated the effects of cranberry (poly)phenols on cardiovascular function in healthy subjects. To our knowledge, no study has investigated the time and intake-dependent effect of cranberry consumption on vascular function in healthy subjects. This information is necessary for the planning of long-term studies aiming to assess the potential beneficial effects of cranberries, using optimal amounts at optimal time points. Therefore, this study aims to investigate the potential role of cranberry (poly)phenols in the modulation of vascular function by monitoring changes in vascular function together with the major (poly)phenol derivatives/metabolites in plasma and urine.

Enrollment: 10 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy male subjects without clinical signs or symptoms of cardiovascular disease

Exclusion criteria

• cardiovascular disease
• acute inflammation
• cardiac arrhythmia
• renal failure
• heart failure (NYHA II-IV)
• diabetes mellitus
• C-reactive protein > 05 mg/dL
• malignant disease
• cranberry allergy/intolerance
• hypotension (≤100 / 60 mm Hg)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10 participants in 6 patient groups, including a placebo group

Cranberry 320

Active Comparator group

Description:

Dietary Supplement: Cranberry beverage with 320 mg of (poly)phenols Acute intake of 500 mL (1x daily)

Treatment:

Dietary Supplement: Cranberry 320

Cranberry 640

Active Comparator group

Description:

Dietary Supplement: Cranberry beverage with 640 mg of (poly)phenols Acute intake of 500 mL (1x daily)

Treatment:

Dietary Supplement: Cranberry 640

Cranberry 960

Active Comparator group

Description:

Dietary Supplement: Cranberry beverage with 960 mg of (poly)phenols Acute intake of 500 mL (1x daily)

Treatment:

Dietary Supplement: Cranberry 960

Cranberry 1280

Active Comparator group

Description:

Dietary Supplement: Cranberry beverage with 1280 mg of (poly)phenols Acute intake of 500 mL (1x daily)

Treatment:

Dietary Supplement: Cranberry 1280

Cranberry 1600

Active Comparator group

Description:

Dietary Supplement: Cranberry beverage with 1600 mg of (poly)phenols Acute intake of 500 mL (1x daily)

Treatment:

Dietary Supplement: Cranberry 1600

Cranberry deprived supplement

Placebo Comparator group

Description:

Placebo comparator: Cranberry deprived supplement Acute intake of 500 mL (1x daily)

Treatment:

Dietary Supplement: Cranberry deprived supplement