NCT00978640

Brief Summary

Hypothesis: during fasting and exercise will there be an activation of sirtuins (Sirt1). Primarily the investigators will investigate Sirt1 activity in muscle- and fat-biopsies after fasting for 36 hours and after 1 hour of ergometer-cycling at 50 Vo2max. In addition to this the investigators will investigate the effect of fasting and exercise on the velocity of carbamide synthesis, aminoacid rate of turnover and glucose rate of turnover.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 20, 2012

Status Verified

June 1, 2012

Enrollment Period

2.8 years

First QC Date

September 16, 2009

Last Update Submit

June 19, 2012

Conditions

Healthy

Keywords

Sirt1 activity

Outcome Measures

Primary Outcomes (1)

  • Sirt1 activity

    60 min

Secondary Outcomes (1)

  • secondary will we investigate the effect of fasting and exercise on the velocity of carbamide synthesis, aminoacid rate of turnover and glucose rate of turnover.

    4 h

Study Arms (2)

fasting and exercise

EXPERIMENTAL

36 h fast and 1 h ergometer cycling 50% VO2max

Other: fast and exercise

exercise

EXPERIMENTAL

1 h ergometer cycling 50% VO2max

Other: exercise

Interventions

fast and exerciseOTHER

fasting 36 h and exercise 1 h 50% VO2max

fasting and exercise
exerciseOTHER

exercise 1 h 50% VO2max

exercise

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy men
  • Body mass index (BMI) 20-26
  • age 18-45 years

You may not qualify if:

  • any kind of disease
  • any use of medicine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

mikkel Holm Vendelbo

Aarhus, Jylland, 8000, Denmark

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2009

First Posted

September 17, 2009

Study Start

September 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

June 20, 2012

Record last verified: 2012-06

Locations

DK(1)