Sedentary LifestyleNCT02624011
Influence of Sedentary Time on Skeletal Muscle Protein Metabolism
A study testing 7 days of habitual physical activity followed by 7 days of reduced physical activity in people with Sedentary Lifestyle, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
This study will investigate the influence of increased sedentary time on long-term measures of muscle protein synthesis and metabolic health. The investigators will test the hypothesis that increased time spent in sedentary behaviours will lead to a reduction in long-term measures of muscle protein synthesis and… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- 7 days of habitual physical activity followed by 7 days of reduced physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2016to Feb 2018
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (18.5-29.99 kg/m2)
- Active - defined as: ≥ 7000 steps per day (assessed during screening) and taking part in regular exercise (defined as participation in ≥ 3 sessions of aerobic and/or resistance exercise type sessions a week for ≥ 6 months prior to recruitment)
- Good general health
Who cannot join
- Lidocaine allergy
- Hypertension (≥140/90 mmHg)
- Current participation in another clinical study
- Previous participation in this study
- Bleeding disorder/s
- Current or recent smoker
- Past history of substance abuse and/or taking prescription or non-prescription medication (e.g., beta-blockers, insulin or thyroxine) or supplements that may influence normal metabolic responses.
- Participants who have previously (within 5 years of the present study) had 4 or more muscle biopsies obtained from the thigh quadriceps region will be ineligible.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Sport Exercise and Rehabilitation Sciences, University of Birmingham
Birmingham, B15 2TT
About this study
Official title: Influence of Increased Sedentary Time on Long-term Rates of Skeletal Muscle Protein Synthesis in Young Adults
This study will investigate the influence of increased sedentary time on long-term measures of muscle protein synthesis and metabolic health. The investigators will test the hypothesis that increased time spent in sedentary behaviours will lead to a reduction in long-term measures of muscle protein synthesis and compromised metabolic health.
Read the detailed description
Sarcopenia, the loss of muscle mass with age, is thought to be accelerated by an inactive, sedentary lifestyle. Increased sedentary time has consistently been associated with lower muscle mass and compromised metabolic health. However, there is currently a lack of direct evidence to support these associations.
Therefore, this study will investigate whether increased sedentary time (reduced step count and exercise cessation) directly influences long-term measures of muscle protein synthesis and metabolic health in young, active adults. Following a 7 day period of normal habitual physical activity, participants will undertake a 7 day period of step reduction and exercise cessation. It is hypothesised that 7 days of increased sedentary time will result in a reduction in long-term rates of muscle protein synthesis and a worsening of metabolic health.
- Conditions
- Sedentary Lifestyle
- Being tested
- 7 days of habitual physical activity followed by 7 days of reduced physical activity
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7 days of habitual physical activity followed by 7 days of reduced physical activityBehavioural
Young, active participants will undergo a 7 day period of habitual physical activity followed by a 7 day period of step reduction and exercise cessation.
| Study group | Role | What they receive |
|---|---|---|
| Physical inactivity | Experimental | Study arm consisting of 7 days of habitual physical activity followed by 7 days of step reduction and exercise cessation. Receives: Behavioral: 7 days of habitual physical activity followed by 7 days of reduced physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein synthesis (FSR %/day)
Long-term muscle protein synthesis (FSR %/day) will be determined using deuterium oxide (D2O) to compare muscle protein synthesis rates over the first 7 day period and the second 7 day period.
Measured: 0-14 days
Secondary outcomes (7)
Rate of fat oxidation at rest (g/min)
Whole body oxygen consumption (VO2, L/min) and carbon dioxide production (VCO2, L/min) at rest will be measured using indirect calorimetry to calculate the rate of fat oxidation at rest (g/min).
Measured: For 20 minutes at day 7 and day 14
Rate of fat oxidation during an oral glucose tolerance test (g/min)
Whole body oxygen consumption (VO2, L/min) and carbon dioxide production (VCO2, L/min) following an oral glucose drink will be measured using indirect calorimetry to calculate the rate of fat oxidation during an oral glucose tolerance test (g/min).
Measured: At 0, 30, 60, 90 and 120min of the oral glucose tolerance test at day 7 and day 14
Rate of carbohydrate oxidation at rest (g/min)
Whole body oxygen consumption (VO2, L/min) and carbon dioxide production (VCO2, L/min) at rest will be measured using indirect calorimetry to calculate the rate of carbohydrate oxidation at rest (g/min).
Measured: For 20 minutes at day 7 and day 14
Rate of carbohydrate oxidation during an oral glucose tolerance test (g/min)
Whole body oxygen consumption (VO2, L/min) and carbon dioxide production (VCO2, L/min) following an oral glucose drink will be measured using indirect calorimetry to calculate the rate of carbohydrate oxidation during an oral glucose tolerance test (g/min).
Measured: At 0, 30, 60, 90 and 120min of the oral glucose tolerance test at day 7 and day 14
Blood glucose concentration
Blood glucose concentration will be assessed in blood samples taken during the oral glucose tolerance test.
Measured: At 0, 30, 60, 90 and 120min of the oral glucose tolerance test at day 7 and day 14
Blood insulin concentration
Blood insulin concentration will be assessed in blood samples taken during the oral glucose tolerance test.
Measured: At 0, 30, 60, 90 and 120min of the oral glucose tolerance test at day 7 and day 14
Blood fatty acid concentration
Blood fatty acid concentration will be assessed in blood samples taken during the oral glucose tolerance test.
Measured: At 0, 30, 60, 90 and 120min of the oral glucose tolerance test at day 7 and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startMar 2016
- Primary completionApr 2017
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies 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
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University
- Responsible party
- Sponsor
- Investigators
- Brandon J Shad, BSc, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624011
- Sponsor's protocol ID
- ERN_15-1238
- Status last verified
- Oct 2018
- First submitted
- 2 Dec 2015
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Increased Sedentary Time on Long-term Rates of Skeletal Muscle Protein Synthesis in Young Adults
- ClinicalTrials.gov ID
- NCT02624011
- Acronym / sponsor ID
- ERN_15-1238
- Conditions
- Sedentary Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Maastricht University
- Study start
- Mar 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 8 Dec 2015 (estimated)
- 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.
This study will investigate the influence of increased sedentary time on long-term measures of muscle protein synthesis and metabolic health. The investigators will test the hypothesis that increased time spent in sedentary behaviours will lead to a reduction in long-term measures of muscle protein synthesis and compromised metabolic health.
Detailed description
Sarcopenia, the loss of muscle mass with age, is thought to be accelerated by an inactive, sedentary lifestyle. Increased sedentary time has consistently been associated with lower muscle mass and compromised metabolic health. However, there is currently a lack of direct evidence to support these associations.
Therefore, this study will investigate whether increased sedentary time (reduced step count and exercise cessation) directly influences long-term measures of muscle protein synthesis and metabolic health in young, active adults. Following a 7 day period of normal habitual physical activity, participants will undertake a 7 day period of step reduction and exercise cessation. It is hypothesised that 7 days of increased sedentary time will result in a reduction in long-term rates of muscle protein synthesis and a worsening of metabolic health.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical inactivity | Experimental | Behavioral: 7 days of habitual physical activity followed by 7 days of reduced physical activityStudy arm consisting of 7 days of habitual physical activity followed by 7 days of step reduction and exercise cessation. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (18.5-29.99 kg/m2)
- Active - defined as: ≥ 7000 steps per day (assessed during screening) and taking part in regular exercise (defined as participation in ≥ 3 sessions of aerobic and/or resistance exercise type sessions a week for ≥ 6 months prior to recruitment)
- Good general health
Key exclusion criteria (8 listed)
- Lidocaine allergy
- Hypertension (≥140/90 mmHg)
- Current participation in another clinical study
- Previous participation in this study
- Bleeding disorder/s
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 |
|---|---|---|
| 7 days of habitual physical activity followed by 7 days of reduced physical activityYoung, active participants will undergo a 7 day period of habitual physical activity followed by a 7 day period of step reduction and exercise cessation. | Behavioural | Physical inactivity |
Primary outcome
Muscle protein synthesis (FSR %/day)
Time frame: 0-14 days
Long-term muscle protein synthesis (FSR %/day) will be determined using deuterium oxide (D2O) to compare muscle protein synthesis rates over the first 7 day period and the second 7 day period.
7 secondary outcomes
Rate of fat oxidation at rest (g/min)
Time frame: For 20 minutes at day 7 and day 14
Rate of fat oxidation during an oral glucose tolerance test (g/min)
Time frame: At 0, 30, 60, 90 and 120min of the oral glucose tolerance test at day 7 and day 14
Rate of carbohydrate oxidation at rest (g/min)
Time frame: For 20 minutes at day 7 and day 14
Rate of carbohydrate oxidation during an oral glucose tolerance test (g/min)
Time frame: At 0, 30, 60, 90 and 120min of the oral glucose tolerance test at day 7 and day 14
Blood glucose concentration
Time frame: At 0, 30, 60, 90 and 120min of the oral glucose tolerance test at day 7 and day 14
Blood insulin concentration
Time frame: At 0, 30, 60, 90 and 120min of the oral glucose tolerance test at day 7 and day 14
Blood fatty acid concentration
Time frame: At 0, 30, 60, 90 and 120min of the oral glucose tolerance test at day 7 and day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
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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.
Brandon J Shad, BSc principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7 days of habitual physical activity followed by 7 days of reduced physical activity in people with Sedentary Lifestyle, run by University of Birmingham at 1 site in United Kingdom.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Muscle protein synthesis (FSR %/day) (time frame: 0-14 days). 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 11 Oct 2018.