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Physiological Responses to a Prolonged Cycling Expedition in Older Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02353624
Recruitment Status : Completed
First Posted : February 3, 2015
Last Update Posted : February 3, 2015
Sponsor:
Information provided by (Responsible Party):
Jørn Wulff Helge, University of Copenhagen

Tracking Information
First Submitted Date January 22, 2015
First Posted Date February 3, 2015
Last Update Posted Date February 3, 2015
Study Start Date May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 2, 2015)
Total daily energy expenditure (Measured using the doubly labeled water technique) [ Time Frame: Change from baseline ]
Measured using the doubly labeled water technique
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 2, 2015)
Peak fat oxidation (Measured during incremental submaximal exercise) [ Time Frame: Change from baseline ]
Measured during incremental submaximal exercise
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 2, 2015)
  • Energy intake (Measured using selfreported and supervised food logs) [ Time Frame: Change from baseline ]
    Measured using selfreported and supervised food logs
  • Body composition [ Time Frame: Change from baseline ]
    Measured from isotope dilution
  • Energy Balance (Discrepancy between energy expenditure and intake or changes in body composition) [ Time Frame: Change from baseline ]
    Discrepancy between energy expenditure and intake or changes in body composition
  • Cardiac Stress [ Time Frame: Change from baseline ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Physiological Responses to a Prolonged Cycling Expedition in Older Men
Official Title Physiological Responses to a Prolonged Cycling Expedition in Older Men
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.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Urine samples, muscle and subcutaneous adipose tissue biopsies and venous blood samples.
Sampling Method Non-Probability Sample
Study Population Older male cyclits particpating in the cycling event
Condition Aging
Intervention Behavioral: Cycling
Cycling distance of 2880 km in 14 days
Study Groups/Cohorts Not Provided
Publications * Rosenkilde M, Morville T, Andersen PR, Kjær K, Rasmusen H, Holst JJ, Dela F, Westerterp K, Sjödin 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 2, 2015)
6
Original Actual Enrollment Same as current
Actual Study Completion Date May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Participation in the cycling expedition

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: Male
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT02353624
Other Study ID Numbers Nordkapp cycling study
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jørn Wulff Helge, University of Copenhagen
Study Sponsor University of Copenhagen
Collaborators Not Provided
Investigators
Principal Investigator: Jørn Helge University of Copenhagen
PRS Account University of Copenhagen
Verification Date January 2015