NCT02764749

Brief Summary

Epidemiological studies suggest that the consumption of (poly)phenols rich foods such as cocoa, tea, fruits and vegetables is associated with lower blood pressure, reduced cholesterol and decreased cardiovascular risk. Cranberries are a rich source of (poly)phenols, including anthocyanins, proanthocyanidins and phenolic acids. Whether cranberries can improve vascular function when given over relevant time periods and in relevant populations is not known. Therefore, it is the overall hypothesis of the study proposal that chronic consumption of cranberries can improve endothelial function, a prognostically validated surrogate of cardiovascular risk. This study also aims to reveal which cranberry (poly)phenols have bioactive properties in healthy men. Consequently, plasma and urine metabolite peaks will be correlated with vascular outcomes and genome-wide expression microarrays will be performed to reveal cell signaling pathways associated with cranberry (poly)phenol-mediated cardioprotective events.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

May 4, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
26 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

Enrollment Period

4 months

First QC Date

May 4, 2016

Last Update Submit

November 24, 2016

Conditions

Healthy Young

Keywords

vascular functionendothelial functionpolyphenols

Outcome Measures

Primary Outcomes (1)

  • Change form Baseline Endothelial function at 1 month

    Measured by Flow mediated dilation (FMD)

    2 hours and 1 month

Secondary Outcomes (5)

  • Pulse wave velocity

    Baseline and 1 month

  • Blood pressure

    Baseline and 1month

  • high density lipoproteins (HDL)

    Baseline and 1 month

  • low density lipoproteins (LDL)

    Baseline and 1 month

  • triglyceride

    Baseline and 1 month

Other Outcomes (2)

  • Plasma cranberry (poly)phenol metabolites

    Baseline and 1 month

  • Urinary cranberry (poly)phenol metabolites

    Baseline and 1 month

Study Arms (2)

freeze dried powder whole cranberry dissolved in water

EXPERIMENTAL

Dietary Supplement: freeze dried cranberry powder

Dietary Supplement: cranberry (poly)phenol containing supplement

freeze dried cranberry deprived powder dissolved in water

PLACEBO COMPARATOR

Placebo comparator: freeze dried cranberry deprived powder

Dietary Supplement: Placebo comparator: cranberry (poly)phenol deprived supplement

Interventions

cranberry (poly)phenol containing supplementDIETARY_SUPPLEMENT

Sustained intake of 9 grams of freeze-dried cranberry powder per day (2x 4.5 grams daily over 1 month). The powder is dissolved in water and administered as a drink.

freeze dried powder whole cranberry dissolved in water
Placebo comparator: cranberry (poly)phenol deprived supplementDIETARY_SUPPLEMENT

Sustained intake (2x 4.5 grams daily over 1 month) of a control supplement dissolved in water

freeze dried cranberry deprived powder dissolved in water

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male subjects (no clinical signs or symptoms of CVD)
  • Young \>18 years, \<35 years

You may not qualify if:

  • CVD
  • acute inflammation
  • cardiac arrhythmia
  • renal failure
  • heart failure (NYHA II-IV)
  • diabetes mellitus
  • CRP \> 1 mg/dl
  • malignant disease

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 (2)

  • Heiss C, Istas G, Feliciano RP, Weber T, Wang B, Favari C, Mena P, Del Rio D, Rodriguez-Mateos A. Daily consumption of cranberry improves endothelial function in healthy adults: a double blind randomized controlled trial. Food Funct. 2022 Apr 4;13(7):3812-3824. doi: 10.1039/d2fo00080f.

    PMID: 35322843DERIVED

  • 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-Mateo, PhD

    Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 4, 2016

First Posted

May 6, 2016

Study Start

June 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

November 28, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)