NCT03877822

Brief Summary

The impact of two days bed rest versus two days of habitual activity on insulin sensitivity and cumulative muscle protein synthesis will be investigated in healthy young males

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2021

Status
withdrawn

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

First Submitted

Initial submission to the registry

February 28, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
2.5 years until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2021

Enrollment Period

Same day

First QC Date

February 28, 2019

Last Update Submit

November 9, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in whole-body insulin sensitivity

    Change in whole-body insulin sensitivity via meal tolerance test

    During 2 days of habitual physical activity and 2 days of bed rest. Blood glucose and insulin are monitored for 2 hours following ingestion of a standardized meal

Secondary Outcomes (3)

  • Change in cumulative muscle protein synthesis

    During 2 days of habitual physical activity and 2 days of bed rest

  • Change in continuous glucose

    Continuous glucose, during the 2 days of habitual activity and 2 days of bed rest

  • Change in muscle volume

    Immediately before and immediately after the 2-day bed rest period

Study Arms (1)

Habitual activity and 2 days bed rest

EXPERIMENTAL

Participants will undergo 2 days of habitual activity and 2 days bed rest

Behavioral: Habitual activityBehavioral: Bed rest

Interventions

Two days of habitual physical activity, under normal free-living conditions

Habitual activity and 2 days bed rest
Bed restBEHAVIORAL

Two days of bed rest, to induce whole-body physical inactivity

Habitual activity and 2 days bed rest

Eligibility Criteria

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

You may qualify if:

  • Male
  • Aged 18-40

You may not qualify if:

  • Smoker
  • Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes)
  • Any diagnosed cardiovascular disease (e.g. deep vein thrombosis or hypertension)
  • Chronic use of any prescribed or over the counter pharmaceuticals (that may modulate muscle protein metabolism).
  • A personal or family history of thrombosis, epilepsy, seizures or schizophrenia.
  • Any known disorders in muscle metabolism
  • Regular use of nutritional supplements (i.e. ingestion more than twice per week during the last month)
  • Metallic implants (including heart pacemaker, cochlear implants, medication pumps, surgical clips, plates or screws).
  • Allergy to lidocaine
  • Recent (within the last 6 months) or current musculoskeletal injury (e.g. leg fracture)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Bed Rest

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Marlou L Dirks, PhD

    University of Exeter

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Participants will firstly undergo 2 days of habitual physical activity, followed by 2 days of bed rest
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2019

First Posted

March 18, 2019

Study Start

September 1, 2021

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

November 17, 2021

Record last verified: 2021-11