NCT02517775

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

November 3, 2015

Status Verified

November 1, 2015

Enrollment Period

11 months

First QC Date

July 8, 2015

Last Update Submit

November 2, 2015

Conditions

Healthy Men

Keywords

polyphenolsvascular functionendothelial functioncranberryhealthy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • pulse wave velocity

    Baseline, on week 1, 2, 3, 4 and 5 postconsumption

  • Central blood pressure

    Baseline, on week 1, 2, 3, 4 and 5 postconsumption

  • Peripheral blood pressure

    Baseline, on week 1, 2, 3, 4 and 5 postconsumption

  • Heart Rate

    Baseline, on week 1, 2, 3, 4 and 5 postconsumption

Other Outcomes (2)

  • Plasma (poly)phenol metabolites

    Baseline, on week 1, 2, 3, 4 and 5 postconsumption

  • Urinary (poly)phenol metabolites

    Baseline, on week 1, 2, 3, 4 and 5 postconsumption

Study Arms (6)

Cranberry 320

ACTIVE COMPARATOR

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

Dietary Supplement: Cranberry 320

Cranberry 640

ACTIVE COMPARATOR

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

Dietary Supplement: Cranberry 640

Cranberry 960

ACTIVE COMPARATOR

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

Dietary Supplement: Cranberry 960

Cranberry 1280

ACTIVE COMPARATOR

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

Dietary Supplement: Cranberry 1280

Cranberry 1600

ACTIVE COMPARATOR

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

Dietary Supplement: Cranberry 1600

Cranberry deprived supplement

PLACEBO COMPARATOR

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

Dietary Supplement: Cranberry deprived supplement

Interventions

Cranberry 320DIETARY_SUPPLEMENT

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

Cranberry 320
Cranberry 640DIETARY_SUPPLEMENT

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

Cranberry 640
Cranberry 960DIETARY_SUPPLEMENT

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

Cranberry 960
Cranberry 1280DIETARY_SUPPLEMENT

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

Cranberry 1280
Cranberry 1600DIETARY_SUPPLEMENT

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

Cranberry 1600
Cranberry deprived supplementDIETARY_SUPPLEMENT

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

Cranberry deprived supplement

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf

Düsseldorf, 40225, Germany

Location

Related Publications (1)

  • Mena P, Favari C, Acharjee A, Chernbumroong S, Bresciani L, Curti C, Brighenti F, Heiss C, Rodriguez-Mateos A, Del Rio D. Metabotypes of flavan-3-ol colonic metabolites after cranberry intake: elucidation and statistical approaches. Eur J Nutr. 2022 Apr;61(3):1299-1317. doi: 10.1007/s00394-021-02692-z. Epub 2021 Nov 9.

    PMID: 34750642DERIVED

Study Officials

  • Ana Rodriguez-Mateos, PhD

    Division of Cardiology, Pulmonology and Vascular Medicine

    PRINCIPAL INVESTIGATOR

  • Christian Heiss, MD

    Division of Cardiology, Pulmonology and Vascular Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division of Cardiology, Pulmonary Diseases, Vascular Medicine

Study Record Dates

First Submitted

July 8, 2015

First Posted

August 7, 2015

Study Start

October 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

November 3, 2015

Record last verified: 2015-11

Locations

DE(1)