Healthy2d-BRNCT03877822
Two-day Bed Rest, Insulin Sensitivity and Muscle Protein Synthesis
A study testing Habitual activity and Bed rest in people with Healthy, run by University of Exeter.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Habitual activity and Bed rest
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Aged 18-40
Who cannot join
- 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
Show all 10Show fewer
- 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)
About this study
Official title: The Impact of Two Days of Bed Rest Versus Two Days of Habitual Activity on Insulin Sensitivity and Cumulative Muscle Protein Synthesis in Healthy Young Males
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
Read the detailed description
To study the mechanisms underlying inactivity-induced muscle atrophy, 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
- Conditions
- Healthy
- Being tested
- Habitual activity, Bed rest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Habitual activityBehavioural
Two days of habitual physical activity, under normal free-living conditions
Bed restBehavioural
Two days of bed rest, to induce whole-body physical inactivity
| Study group | Role | What they receive |
|---|---|---|
| Habitual activity and 2 days bed rest | Experimental | Participants will undergo 2 days of habitual activity and 2 days bed rest Receives: Behavioral: Habitual activity; Behavioral: Bed rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in whole-body insulin sensitivity
Change in whole-body insulin sensitivity via meal tolerance test
Measured: 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
Cumulative muscle protein synthesis via deuterium oxide ingestion. The incorporation of deuterated alanine in muscle is expressed relative to body water enrichments, to obtain muscle protein synthesis in %/day
Measured: During 2 days of habitual physical activity and 2 days of bed rest
Change in continuous glucose
Change in continuous glucose via continuous glucose monitoring.
Measured: Continuous glucose, during the 2 days of habitual activity and 2 days of bed rest
Change in muscle volume
Change in muscle volume via MRI
Measured: Immediately before and immediately after the 2-day bed rest period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start1 Sep 2021
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Why it stopped: Study protocol no longer relevant after progression of the scientific field
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will firstly undergo 2 days of habitual physical activity, followed by 2 days of bed rest
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marlou L Dirks, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877822
- Sponsor's protocol ID
- 190206/B/05
- Acronym
- 2d-BR
- Status last verified
- Nov 2021
- First submitted
- 28 Feb 2019
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Two Days of Bed Rest Versus Two Days of Habitual Activity on Insulin Sensitivity and Cumulative Muscle Protein Synthesis in Healthy Young Males
- ClinicalTrials.gov ID
- NCT03877822
- Acronym / sponsor ID
- 2d-BR / 190206/B/05
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study protocol no longer relevant after progression of the scientific field
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
To study the mechanisms underlying inactivity-induced muscle atrophy, 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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will firstly undergo 2 days of habitual physical activity, followed by 2 days of bed rest
| Arm | Type | Receives |
|---|---|---|
| Habitual activity and 2 days bed rest | Experimental | Behavioral: Habitual activity, Behavioral: Bed restParticipants will undergo 2 days of habitual activity and 2 days bed rest |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male
- Aged 18-40
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Habitual activityTwo days of habitual physical activity, under normal free-living conditions | Behavioural | Habitual activity and 2 days bed rest |
| Bed restTwo days of bed rest, to induce whole-body physical inactivity | Behavioural | Habitual activity and 2 days bed rest |
Primary outcome
Change in whole-body insulin sensitivity
Time frame: 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
Change in whole-body insulin sensitivity via meal tolerance test
3 secondary outcomes
Change in cumulative muscle protein synthesis
Time frame: During 2 days of habitual physical activity and 2 days of bed rest
Change in continuous glucose
Time frame: Continuous glucose, during the 2 days of habitual activity and 2 days of bed rest
Change in muscle volume
Time frame: Immediately before and immediately after the 2-day bed rest period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlou L Dirks, PhD principal investigator
University of Exeter
Questions about this trial
What is this clinical trial studying?
A study testing Habitual activity and Bed rest in people with Healthy, run by University of Exeter.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in whole-body insulin sensitivity (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.