Assessing Muscle Amino Acid BalanceNCT02980952
Amino Acid Balance During Physical Inactivity
A study testing High-fat overfeeding and Forearm immobilization in people with Assessing Muscle Amino Acid Balance, run by University of Exeter.
Trial summary
The aim is to assess the impact of physical inactivity on muscle amino acid balance and forearm glucose uptake. In addition, we will evaluate how high-fat overfeeding will modulate muscle amino acid balance and forearm glucose uptake. 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
- Assessing Muscle Amino Acid Balance
- What is being tested?
- High-fat overfeeding and Forearm immobilization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Sep 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 18 and 30
Who cannot join
- Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes).
- Any diagnosed cardiovascular disease or hypertension.
- Elevated blood pressure at the time of screening. (An average systolic blood pressure reading of ≥140 mmHg over two or more measurements and an average diastolic blood pressure of ≥90 mmHg over two or more measurements.)
- Chronic use of any prescribed or over the counter pharmaceuticals.
- Regular use of nutritional supplements (e.g. creatine, protein supplementation)
- Metallic implants (including heart pacemaker, cochlear implants, medication pumps, surgical clips, plates or screws).
- A personal or family history of thrombosis, epilepsy, seizures or schizophrenia.
- Any previous motor disorders.
About this study
The aim is to assess the impact of physical inactivity on muscle amino acid balance and forearm glucose uptake. In addition, we will evaluate how high-fat overfeeding will modulate muscle amino acid balance and forearm glucose uptake.
Read the detailed description
The aim is to assess the impact of forearm cast immobilization on muscle amino acid balance and forearm glucose uptake. In addition, we will evaluate how high-fat overfeeding during immobilization will modulate muscle amino acid balance and forearm glucose uptake.
- Conditions
- Assessing Muscle Amino Acid Balance
- Being tested
- High-fat overfeeding, Forearm immobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-fat overfeedingOther
Forearm immobilizationOther
| Study group | Role | What they receive |
|---|---|---|
| Energy-balanced diet | Placebo comparator | Forearm immobilization whilst consuming an energy-balanced diet Receives: Other: Forearm immobilization |
| High-fat overfeeding | Experimental | Forearm immobilization whilst consuming a high-fat diet, 50% energy excess Receives: Other: High-fat overfeeding; Other: Forearm immobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle amino acid balance
Forearm muscle amino acid balance
Measured: 3 hours
Secondary outcomes (1)
Glucose uptake
Forearm glucose uptake
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Assessing Muscle Amino Acid BalanceStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin T Wall, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980952
- Sponsor's protocol ID
- 157758/03
- Status last verified
- Oct 2018
- First submitted
- 30 Nov 2016
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wall BT, Cruz AM, Otten B, Dunlop MV, Fulford J, Porter C, Abdelrahman DR, Stephens FB, Dirks ML. The Impact of Disuse and High-Fat Overfeeding on Forearm Muscle Amino Acid Metabolism in Humans. J Clin Endocrinol Metab. 2020 Jul 1;105(7):dgaa184. doi: 10.1210/clinem/dgaa184.
PubMed 32303743Dirks ML, Wall BT, Otten B, Cruz AM, Dunlop MV, Barker AR, Stephens FB. High-fat Overfeeding Does Not Exacerbate Rapid Changes in Forearm Glucose and Fatty Acid Balance During Immobilization. J Clin Endocrinol Metab. 2020 Jan 1;105(1):dgz049. doi: 10.1210/clinem/dgz049.
PubMed 31609422
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amino Acid Balance During Physical Inactivity
- ClinicalTrials.gov ID
- NCT02980952
- Acronym / sponsor ID
- 157758/03
- Conditions
- Assessing Muscle Amino Acid Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 2 Dec 2016 (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.
The aim is to assess the impact of physical inactivity on muscle amino acid balance and forearm glucose uptake. In addition, we will evaluate how high-fat overfeeding will modulate muscle amino acid balance and forearm glucose uptake.
Detailed description
The aim is to assess the impact of forearm cast immobilization on muscle amino acid balance and forearm glucose uptake. In addition, we will evaluate how high-fat overfeeding during immobilization will modulate muscle amino acid balance and forearm glucose uptake.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Energy-balanced diet | Placebo comparator | Other: Forearm immobilizationForearm immobilization whilst consuming an energy-balanced diet |
| High-fat overfeeding | Experimental | Other: High-fat overfeeding, Other: Forearm immobilizationForearm immobilization whilst consuming a high-fat diet, 50% energy excess |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI between 18 and 30
Key exclusion criteria (8 listed)
- Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes).
- Any diagnosed cardiovascular disease or hypertension.
- Elevated blood pressure at the time of screening. (An average systolic blood pressure reading of ≥140 mmHg over two or more measurements and an average diastolic blood pressure of ≥90 mmHg over two or more measurements.)
- Chronic use of any prescribed or over the counter pharmaceuticals.
- Regular use of nutritional supplements (e.g. creatine, protein supplementation)
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 |
|---|---|---|
| High-fat overfeeding | Other | High-fat overfeeding |
| Forearm immobilization | Other | Energy-balanced diet, High-fat overfeeding |
Primary outcome
Muscle amino acid balance
Time frame: 3 hours
Forearm muscle amino acid balance
1 secondary outcome
Glucose uptake
Time frame: 3 hours
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 25 Oct 2018.
- Derived from this study: PubMed 32303743Wall BT, Cruz AM, Otten B, Dunlop MV, Fulford J, Porter C, Abdelrahman DR, Stephens FB, Dirks ML. The Impact of Disuse and High-Fat Overfeeding on Forearm Muscle Amino Acid Metabolism in Humans. J Clin Endocrinol Metab. 2020 Jul 1;105(7):dgaa184. doi: 10.1210/clinem/dgaa184.
- Derived from this study: PubMed 31609422Dirks ML, Wall BT, Otten B, Cruz AM, Dunlop MV, Barker AR, Stephens FB. High-fat Overfeeding Does Not Exacerbate Rapid Changes in Forearm Glucose and Fatty Acid Balance During Immobilization. J Clin Endocrinol Metab. 2020 Jan 1;105(1):dgz049. doi: 10.1210/clinem/dgz049.
- Individual participant dataSharing planned: No
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.
Benjamin T Wall, PhD principal investigator
University of Exeter
Questions about this trial
What is this clinical trial studying?
A study testing High-fat overfeeding and Forearm immobilization in people with Assessing Muscle Amino Acid Balance, 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 1 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 25 Oct 2018. 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. Some participants in this study may receive a placebo. 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 amino acid balance (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02980952, which also lists 2 linked publications.
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 25 Oct 2018.