NCT02981927

Brief Summary

To evaluate the early metabolic responses (whole body and within muscle tissue) to a single day of whole body physical inactivity (i.e. bed-rest), and evaluate the contribution of inactivity per se vs alterations in diet

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration 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

January 1, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2016

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
Last Updated

May 25, 2018

Status Verified

May 1, 2018

Enrollment Period

1.9 years

First QC Date

November 30, 2016

Last Update Submit

May 23, 2018

Conditions

Metabolic Responses to Inactivity

Outcome Measures

Primary Outcomes (1)

  • Glucose tolerance

    24 hours

Study Arms (3)

Control

NO INTERVENTION

24 h habitual physical activity fed in energy balance

Bed rest matched diet

EXPERIMENTAL

24 hour period of whole body bed-rest with a matched diet

Other: Physical inactivity

Bed rest balanced diet

EXPERIMENTAL

24 hour period of whole body bed-rest fed in energy balance

Other: Physical inactivity

Interventions

Physical inactivityOTHER
Bed rest balanced dietBed rest matched diet

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy and aged 18-40 y
  • BMI between 18 and 30

You may not qualify if:

  • On medication
  • Family history of metabolic disease
  • Diagnosed with any metabolic or cardiovascular conditions
  • BMI \< 18 or \> 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sport & Health Sciences

Exeter, Devon, EX1 2LU, United Kingdom

Location

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

November 30, 2016

First Posted

December 5, 2016

Study Start

January 1, 2015

Primary Completion

December 2, 2016

Study Completion

December 2, 2016

Last Updated

May 25, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)