Effects of Cranberry Consumption in Vascular Function in Healthy Individuals

Healthy Men Clinical Trial

— Cranberry  

Official title:

Intake and Time-dependent Effects of Cranberry (Poly)Phenol Consumption in Vascular Function in Healthy Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02517775
• Other study ID #: 14-012
• Status: Completed
• Phase: N/A
• First received: July 8, 2015
• Last updated: November 2, 2015
• Start date: October 2014
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Men

Intervention

Dietary Supplement:
• Cranberry 320
Dietary Supplement: Cranberry beverage with 320 mg of (poly)phenols Acute intake of 500 mL (1x daily)
• Cranberry 640
Dietary Supplement: Cranberry beverage with 640 mg of (poly)phenols Acute intake of 500 mL (1x daily)
• Cranberry 960
Dietary Supplement: Cranberry beverage with 960 mg of (poly)phenols Acute intake of 500 mL (1x daily)
• Cranberry 1280
Dietary Supplement: Cranberry beverage with 1280 mg of (poly)phenols Acute intake of 500 mL (1x daily)
• Cranberry 1600
Dietary Supplement: Cranberry beverage with 1600 mg of (poly)phenols Acute intake of 500 mL (1x daily)
• Cranberry deprived supplement
Cranberry deprived supplement Acute intake of 500 mL (1x daily)

Locations

Country	Name	City	State
Germany	Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf	Duesseldorf

Sponsors (2)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf	The Cranberry Institute

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma (poly)phenol metabolites	measured by ultra-performance liquid chromatography quadrupole time of flight mass spectrometry (UPLC-Q-TOF MS) at 0,1, 2, 4, 6, 8 and 24 hours after intake	Baseline, on week 1, 2, 3, 4 and 5 postconsumption	No
Other	Urinary (poly)phenol metabolites	measured by ultra-performance liquid chromatography quadrupole time of flight mass spectrometry (UPLC-Q-TOF MS) at 0, 8 and 24 hours after intake	Baseline, on week 1, 2, 3, 4 and 5 postconsumption	No
Primary	Endothelial function	measured by Flow mediated dilation at 1, 2, 4, 6 and 8 hours after intake	Baseline, on week 1, 2, 3, 4 and 5 postconsumption	No
Secondary	pulse wave velocity	measured by SphygmoCor at 0, 1, 2, 4, 6 and 8 hours after intake	Baseline, on week 1, 2, 3, 4 and 5 postconsumption	No
Secondary	Central blood pressure	measured by SphygmoCor at 0, 1.5, 4, 6 and 8 hours after intake	Baseline, on week 1, 2, 3, 4 and 5 postconsumption	No
Secondary	Peripheral blood pressure	measured by automatic sphygmomanometer at 0, 1, 2, 4, 6 and 8 hours after intake	Baseline, on week 1, 2, 3, 4 and 5 postconsumption	No
Secondary	Heart Rate	measured by SphygmoCor 0, 1, 2, 4, 6 and 8 hours after intake	Baseline, on week 1, 2, 3, 4 and 5 postconsumption	No