NCT02353624

Brief Summary

The aim of this study was to test the physiological response to a 2800 km cycling expedition, from Copenhagen, Denmark to Nordkapp, Norway, in a group of older male recreational cyclists.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2011

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

May 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 3, 2015

Completed
Last Updated

February 3, 2015

Status Verified

January 1, 2015

Enrollment Period

Same day

First QC Date

January 22, 2015

Last Update Submit

February 2, 2015

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

  • Total daily energy expenditure (Measured using the doubly labeled water technique)

    Measured using the doubly labeled water technique

    Change from baseline

Secondary Outcomes (1)

  • Peak fat oxidation (Measured during incremental submaximal exercise)

    Change from baseline

Other Outcomes (4)

  • Energy intake (Measured using selfreported and supervised food logs)

    Change from baseline

  • Body composition

    Change from baseline

  • Energy Balance (Discrepancy between energy expenditure and intake or changes in body composition)

    Change from baseline

  • +1 more other outcomes

Interventions

CyclingBEHAVIORAL

Cycling distance of 2880 km in 14 days

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Older male cyclits particpating in the cycling event

You may qualify if:

  • Participation in the cycling expedition

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen, Department of Biomedical Sciences

Copenhagen N, 2200, Denmark

Location

Related Publications (1)

  • Rosenkilde M, Morville T, Andersen PR, Kjaer K, Rasmusen H, Holst JJ, Dela F, Westerterp K, Sjodin A, Helge JW. Inability to match energy intake with energy expenditure at sustained near-maximal rates of energy expenditure in older men during a 14-d cycling expedition. Am J Clin Nutr. 2015 Dec;102(6):1398-405. doi: 10.3945/ajcn.115.109918. Epub 2015 Oct 21.

    PMID: 26490491DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples, muscle and subcutaneous adipose tissue biopsies and venous blood samples.

Study Officials

  • Jørn Helge

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 22, 2015

First Posted

February 3, 2015

Study Start

May 1, 2011

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

February 3, 2015

Record last verified: 2015-01

Locations

DK(1)