Muscle, SkeletalPhase 1NCT02535897
Protein Ingestion and Muscle Carnitine Uptake
A Phase 1 study testing Flavoured water, Flavoured water + carbohydrate and Flavoured water + carbohydrate + protein in people with Muscle, Skeletal, run by University of Nottingham.
Trial summary
The purpose of this study is to assess the effects of a protein-carbohydrate beverage on the absorption of an orally ingested bolus of L-carnitine, compared to flavoured water and carbohydrate-only controls, and to determine whether increasing plasma carnitine availability can impact upon insulin-stimulated muscle… 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
- Muscle, Skeletal
- What is being tested?
- Flavoured water, Flavoured water + carbohydrate and Flavoured water + carbohydrate + protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Jul 2014
- Phase
- Phase 1
- 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
- Healthy
- Body mass index of 18-25 kg/cm2
Who cannot join
- Unhealthy
- Smoker
- Taking any medication that interferes with skeletal muscle metabolism
About this study
Official title: The Effects of an Insulinotropic Protein-carbohydrate Beverage on L- Carnitine Absorption and Muscle Carnitine Uptake
The purpose of this study is to assess the effects of a protein-carbohydrate beverage on the absorption of an orally ingested bolus of L-carnitine, compared to flavoured water and carbohydrate-only controls, and to determine whether increasing plasma carnitine availability can impact upon insulin-stimulated muscle carnitine uptake.
- Conditions
- Muscle, Skeletal
- Being tested
- Flavoured water, Flavoured water + carbohydrate, Flavoured water + carbohydrate + protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavoured waterDietary supplement
Flavoured water + carbohydrateDietary supplement
Flavoured water + carbohydrate + proteinDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| CON | Placebo comparator | 500 ml of flavoured water Receives: Dietary Supplement: Flavoured water |
| CHO | Active comparator | 500 ml of flavoured water containing 80 g carbohydrate Receives: Dietary Supplement: Flavoured water + carbohydrate |
| CHO-PRO | Active comparator | 500 ml of flavoured water containing 40 g carbohydrate and 40 g whey protein Receives: Dietary Supplement: Flavoured water + carbohydrate + protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle carnitine uptake
Change in forearm carnitine uptake (measured using arterialised-venous - venous balance technique) in response to intervention.
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study startJul 2013
- Primary completionFeb 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle, SkeletalStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535897
- Sponsor's protocol ID
- G26062012 BMS
- Status last verified
- Aug 2015
- First submitted
- 24 Aug 2015
- Last updated
- 31 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Insulinotropic Protein-carbohydrate Beverage on L- Carnitine Absorption and Muscle Carnitine Uptake
- ClinicalTrials.gov ID
- NCT02535897
- Acronym / sponsor ID
- G26062012 BMS
- Conditions
- Muscle, Skeletal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 31 Aug 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.
The purpose of this study is to assess the effects of a protein-carbohydrate beverage on the absorption of an orally ingested bolus of L-carnitine, compared to flavoured water and carbohydrate-only controls, and to determine whether increasing plasma carnitine availability can impact upon insulin-stimulated muscle carnitine uptake.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CON | Placebo comparator | Dietary Supplement: Flavoured water500 ml of flavoured water |
| CHO | Active comparator | Dietary Supplement: Flavoured water + carbohydrate500 ml of flavoured water containing 80 g carbohydrate |
| CHO-PRO | Active comparator | Dietary Supplement: Flavoured water + carbohydrate + protein500 ml of flavoured water containing 40 g carbohydrate and 40 g whey protein |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy
- Body mass index of 18-25 kg/cm2
Key exclusion criteria (3 listed)
- Unhealthy
- Smoker
- Taking any medication that interferes with skeletal muscle metabolism
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 |
|---|---|---|
| Flavoured water | Dietary supplement | CON |
| Flavoured water + carbohydrate | Dietary supplement | CHO |
| Flavoured water + carbohydrate + protein | Dietary supplement | CHO-PRO |
Primary outcome
Muscle carnitine uptake
Time frame: 180 minutes
Change in forearm carnitine uptake (measured using arterialised-venous - venous balance technique) in response to intervention.
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 31 Aug 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Flavoured water, Flavoured water + carbohydrate and Flavoured water + carbohydrate + protein in people with Muscle, Skeletal, run by University of Nottingham.
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 3 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 31 Aug 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 carnitine uptake (time frame: 180 minutes). 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 31 Aug 2015.