NCT00933218

Brief Summary

The purpose of the study is to determine the myocardial function and vascular adaptation after strenuous exercise in association with consumption of polyphenols. The investigators aim to investigate the effects of extreme endurance exercise on the inflammatory system. Furthermore, the role of the cardiovascular response and adaptive mechanisms of the vasculature are examined. Subclinical injuries to the myocardium and vascular wall are being investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2009

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

Study Start

First participant enrolled

June 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 7, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

October 20, 2010

Status Verified

July 1, 2009

Enrollment Period

5 months

First QC Date

June 29, 2009

Last Update Submit

October 19, 2010

Conditions

InflammationHeart FailureSudden Cardiac Death

Outcome Measures

Primary Outcomes (1)

  • Inflammatory marker: Interleukin 6 and Interleukin 10

    pre-, post-, one & three day follow-up

Secondary Outcomes (2)

  • E/E' ratio

    pre-, post-, one & three day follow-up

  • AV-ratio

    pre-, post-, one & three day follow-up

Study Arms (2)

polyphenols (non-alcoholic beer)

ACTIVE COMPARATOR
Dietary Supplement: polyphenols (non-alcoholic beer)

beverage without polyphenols

PLACEBO COMPARATOR
Dietary Supplement: beverage without polyphenols

Interventions

polyphenols (non-alcoholic beer)DIETARY_SUPPLEMENT

1.0 - 1.5 l non-alcoholic beer per day; 3 weeks before and during a marathon run

polyphenols (non-alcoholic beer)
beverage without polyphenolsDIETARY_SUPPLEMENT

1.0 - 1.5 l of beverage without polyphenols (otherwise the same composition as non-alcoholic beer) per day; 3 weeks before and during a marathon run

beverage without polyphenols

Eligibility Criteria

Age20 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • men aged 20-60 years

You may not qualify if:

  • manifested heart disease
  • insulin dependent diabetes mellitus
  • multi drug therapy
  • GFR \< 60 ml/min
  • smokers
  • neoplasia
  • (former) alcoholism
  • known malabsorption
  • known chronic inflammatory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Prevention and Sports medicine

Munich, Bavaria, 80809, Germany

Location

Related Publications (5)

  • Schoenfeld J, Schindler MJ, Haller B, Holdenrieder S, Nieman DC, Halle M, La Gerche A, Scherr J. Prospective long-term follow-up analysis of the cardiovascular system in marathon runners: study design of the Pro-MagIC study. BMJ Open Sport Exerc Med. 2020 Jul 19;6(1):e000786. doi: 10.1136/bmjsem-2020-000786. eCollection 2020.

    PMID: 32704381DERIVED

  • Roeh A, Schuster T, Jung P, Schneider J, Halle M, Scherr J. Two dimensional and real-time three dimensional ultrasound measurements of left ventricular diastolic function after marathon running: results from a substudy of the BeMaGIC trial. Int J Cardiovasc Imaging. 2019 Oct;35(10):1861-1869. doi: 10.1007/s10554-019-01634-5. Epub 2019 Jun 1.

    PMID: 31154595DERIVED

  • Scherr J, Halle M. Amendment on the findings of two previously published articles. Eur J Prev Cardiol. 2018 Mar;25(5):558. doi: 10.1177/2047487317754279. Epub 2018 Jan 26. No abstract available.

    PMID: 29370708DERIVED

  • Scherr J, Schuster T, Pressler A, Roeh A, Christle J, Wolfarth B, Halle M. Repolarization perturbation and hypomagnesemia after extreme exercise. Med Sci Sports Exerc. 2012 Sep;44(9):1637-43. doi: 10.1249/MSS.0b013e318258aaf4.

    PMID: 22543737DERIVED

  • Scherr J, Braun S, Schuster T, Hartmann C, Moehlenkamp S, Wolfarth B, Pressler A, Halle M. 72-h kinetics of high-sensitive troponin T and inflammatory markers after marathon. Med Sci Sports Exerc. 2011 Oct;43(10):1819-27. doi: 10.1249/MSS.0b013e31821b12eb.

    PMID: 21448080DERIVED

MeSH Terms

Conditions

InflammationHeart FailureDeath, Sudden, Cardiac

Interventions

PolyphenolsBeverages

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesHeart ArrestDeath, SuddenDeath

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 29, 2009

First Posted

July 7, 2009

Study Start

June 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

October 20, 2010

Record last verified: 2009-07

Locations

DE(1)