HealthyNCT03571425
The Impact of Enteral Versus Oral Protein Feeding on Muscle Protein Synthesis in Healthy Young Males and Females
A study testing Oral Protein and Enteral Protein in people with Healthy, run by University of Exeter at 1 site in United Kingdom.
Trial summary
The present study will seek to quantify the muscle protein synthetic response to a protein beverage consumed orally or through a nasogastric tube in healthy, young individuals. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Oral Protein and Enteral Protein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jun 2018to 1 Dec 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-40 years of age
- Body mass index between 18.5 and 30
Who cannot join
- Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes)
- Any diagnosed cardiovascular disease
- 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 (that may modulate muscle protein metabolism). This excludes oral contraceptives and contraceptive devices.
- A personal or family history of epilepsy, seizures or schizophrenia.
- Presence of an ulcer in the stomach or gut and/or strong history of indigestion
Show all 13Show fewer
- Known pre-existing liver disease/condition
- Any known disorders in muscle metabolism
- Regular use of nutritional supplements
- Allergy to lidocaine
- Allergy to milk
- Current paracetamol use (i.e. use of paracetamol more than once a week)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The present study will seek to quantify the muscle protein synthetic response to a protein beverage consumed orally or through a nasogastric tube in healthy, young individuals.
Read the detailed description
Thirty healthy, young volunteers will receive a stable isotope tracer infusion (8.5h) combined with repeated blood and muscle sampling, in order to measure muscle protein synthesis rate in the postabsorptive state, and following oral placebo ingestion (n=10), oral protein ingestion (n=10), or enteral protein administration (n=10).
- Conditions
- Healthy
- Being tested
- Oral Placebo, Oral Protein, Enteral Protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral PlaceboOther
A placebo beverage will be consumed orally
Oral ProteinOther
A protein beverage will be consumed orally
Enteral ProteinOther
A protein beverage will be consumed via a naso-gastric feeding tube
| Study group | Role | What they receive |
|---|---|---|
| Oral Placebo | Placebo comparator | Placebo drink Receives: Other: Oral Placebo |
| Oral Protein | Active comparator | Protein drink, ingested orally Receives: Other: Oral Protein |
| Enteral Protein | Active comparator | Protein drink, administered via enteral tube Receives: Other: Enteral Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial muscle protein synthesis
Muscle protein synthesis rate (FSR) following ingestion of a placebo or protein supplement
Measured: 5 hours
Secondary outcomes (8)
Postabsorptive muscle protein synthesis
Muscle protein synthesis rate (FSR, in %/h) during a 2 hour fasting period
Measured: 2 hours
Whole-body protein synthesis
Whole-body protein synthesis, measured using a D5 phenylalanine and D2 tyrosine infusion (umol Phenylalanine/kg/h)
Measured: 7 hours
Whole-body protein breakdown
Whole-body protein breakdown, measured using a D5 phenylalanine and D2 tyrosine infusion (umol Phenylalanine/kg/h)
Measured: 7 hours
Whole-body protein oxidation
Whole-body protein oxidation, measured using a D5 phenylalanine and D2 tyrosine infusion (umol Phenylalanine/kg/h)
Measured: 7 hours
Whole-body protein net balance
Whole-body protein net balance, measured using a D5 phenylalanine and D2 tyrosine infusion (umol Phenylalanine/kg/h)
Measured: 7 hours
Gastric emptying rate
Gastric emptying rate following ingestion of a placebo or protein drink
Measured: 5 hours
Blood glucose concentration
Blood glucose concentration in the postabsorptive and postprandial phase following placebo/protein ingestion
Measured: 8.5 hours
Serum insulin concentration
Serum insulin concentration in the postabsorptive and postprandial phase following placebo/protein ingestion
Measured: 8.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start4 Jun 2018
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marlou Dirks, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571425
- Sponsor's protocol ID
- 180509/B/03
- Status last verified
- Dec 2018
- First submitted
- 24 May 2018
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Enteral Versus Oral Protein Feeding on Muscle Protein Synthesis in Healthy Young Males and Females
- ClinicalTrials.gov ID
- NCT03571425
- Acronym / sponsor ID
- 180509/B/03
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 27 Jun 2018 (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 present study will seek to quantify the muscle protein synthetic response to a protein beverage consumed orally or through a nasogastric tube in healthy, young individuals.
Detailed description
Thirty healthy, young volunteers will receive a stable isotope tracer infusion (8.5h) combined with repeated blood and muscle sampling, in order to measure muscle protein synthesis rate in the postabsorptive state, and following oral placebo ingestion (n=10), oral protein ingestion (n=10), or enteral protein administration (n=10).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral Placebo | Placebo comparator | Other: Oral PlaceboPlacebo drink |
| Oral Protein | Active comparator | Other: Oral ProteinProtein drink, ingested orally |
| Enteral Protein | Active comparator | Other: Enteral ProteinProtein drink, administered via enteral tube |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-40 years of age
- Body mass index between 18.5 and 30
Key exclusion criteria (13 listed)
- Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes)
- Any diagnosed cardiovascular disease
- 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 (that may modulate muscle protein metabolism). This excludes oral contraceptives and contraceptive devices.
- A personal or family history of 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 |
|---|---|---|
| Oral PlaceboA placebo beverage will be consumed orally | Other | Oral Placebo |
| Oral ProteinA protein beverage will be consumed orally | Other | Oral Protein |
| Enteral ProteinA protein beverage will be consumed via a naso-gastric feeding tube | Other | Enteral Protein |
Primary outcome
Postprandial muscle protein synthesis
Time frame: 5 hours
Muscle protein synthesis rate (FSR) following ingestion of a placebo or protein supplement
8 secondary outcomes
Postabsorptive muscle protein synthesis
Time frame: 2 hours
Whole-body protein synthesis
Time frame: 7 hours
Whole-body protein breakdown
Time frame: 7 hours
Whole-body protein oxidation
Time frame: 7 hours
Whole-body protein net balance
Time frame: 7 hours
Gastric emptying rate
Time frame: 5 hours
Blood glucose concentration
Time frame: 8.5 hours
Serum insulin concentration
Time frame: 8.5 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 20 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Marlou Dirks, PhD principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Protein and Enteral Protein in people with Healthy, run by University of Exeter 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 2 inclusion and 13 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 20 Dec 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. 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?
Postprandial muscle protein synthesis (time frame: 5 hours). 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 20 Dec 2018.