Old Age (Focus; Not a Recognized Condition)Ajinomoto1ANCT01735539
Dysfunction of Nutritive Blood Flow as a Determinant of Anabolic Resistance With Age; the Role of Amino Acids in Modulating Muscle Metabolism
A study testing 15g EAA bolus, 4 x 3.75g Mixed EAA Pulses and 15g EAA Bolus supplemented with 3g Arginine in people with Old Age (Focus; Not a Recognized Condition), run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The investigators plan to measure changes in muscle protein metabolism in response to feeding, comparing between a single large essential amino acid (EAA) feed (the normal building blocks of protein) and the provision of the same dose in 4 smaller feeds at 45min intervals. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Old Age (Focus; Not a Recognized Condition)
- What is being tested?
- 15g EAA bolus, 4 x 3.75g Mixed EAA Pulses and 15g EAA Bolus supplemented with 3g Arginine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2011to Jan 2014
- 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 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 65-75 or 18-28
Who cannot join
- BMI >30
- Diabetes
- Beta blocker or steroid use
- Established cerebrovascular, peripheral vascular or ischaemic heart disease.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham School of Graduate Entry Medicine and Health
Derby, DE23 6PF
About this study
Official title: Dysfunction of Nutritive Blood Flow as a Determinant of Anabolic Resistance in Older People; The Role of Essential Amino Acids in Modulating Muscle Protein Metabolism; Bolus vs. Pulse Feeding Strategies and the Ability of Arginine to Rejuvenate Microvascular Responsiveness.
The investigators plan to measure changes in muscle protein metabolism in response to feeding, comparing between a single large essential amino acid (EAA) feed (the normal building blocks of protein) and the provision of the same dose in 4 smaller feeds at 45min intervals. The investigators will perform this study in healthy older (65-75y) and younger (18-28) men. The investigators will also explore how feeding affects muscle blood flow as this is important in the delivery of the nutrients we eat to the muscle where they are used.
The investigators plan to supplement the feed with arginine, a safe and widely found non-essential amino acid, to explore if this can improve muscle blood flow.
Read the detailed description
We will provide a 15g mixed essential amino acid feed or 4 x 3.75g.
There is sexual dimorphism thus initially we will just recruit males. Powering calculations dictate n=8 in each group.
We will use well established stable isotope tracer techniques (with 13C6 Phenylalanine) to measure muscle protein synthesis and breakdown by Gas Chromatography - combustion - isotope ratio mass spectroscopy.
We will measure leg blood flow by phase shift Doppler and muscle microvascular flow by contrast enhanced ultrasound.
- Being tested
- 15g EAA bolus, 4 x 3.75g Mixed EAA Pulses, 15g EAA Bolus supplemented with 3g Arginine
- Keywords
- old age, sarcopenia, essential amino acid, arginine, contrast enhanced ultrasound, muscle microcirculation, muscle protein synthesis
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15g EAA bolusDietary supplement
Also called Mixed Essential Amino Acids
Oral; in aqueous solution
4 x 3.75g Mixed EAA PulsesDietary supplement
Oral; in aqueous solution
15g EAA Bolus supplemented with 3g ArginineDietary supplement
Oral; in aqueous solution
| Study group | Role | What they receive |
|---|---|---|
| Old Bolus | Experimental | 15g EAA bolus Receives: Dietary Supplement: 15g EAA bolus |
| Old Arginine | Experimental | 15g EAA Bolus supplemented with 3g Arginine Receives: Dietary Supplement: 15g EAA Bolus supplemented with 3g Arginine |
| Young Bolus | Experimental | 15g EAA bolus Receives: Dietary Supplement: 15g EAA bolus |
| Young Pulse | Experimental | 4 x 3.75g Mixed EAA Pulses Receives: Dietary Supplement: 4 x 3.75g Mixed EAA Pulses |
| Old Pulse | Experimental | 4 x 3.75g Mixed EAA Pulses Receives: Dietary Supplement: 4 x 3.75g Mixed EAA Pulses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Protein Synthesis (FSR, fractional synthetic rate, %/hr)
We measure FSR when fasted and again 0-90, 90-180 and 180-240 post feed.
Measured: Across 6hr study
Secondary outcomes (3)
Muscle Protein Breakdown (MPB)
MBP is measured during fasting and 0-90, 90-180 and 180-240mins post feed.
Measured: Across 6hr study
Whole leg blood flow
We measure common femoral blood flow by doppler ultrasound when fasted and again 0-90, 90-180 and 180-240 post feed.
Measured: Across a 6hr study
Muscle Microvascular Blood flow
We measure muscle microvascular flow using contrast enhanced ultrasound when fasted and again 0-90, 90-180 and 180-240 post feed.
Measured: Across a 6hr study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startDec 2011
- Primary completionJan 2014
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Old Age (Focus; Not a Recognized Condition)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip J Atherton, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735539
- Sponsor's protocol ID
- UNottingham F/3/2009
- Acronym
- Ajinomoto1A
- Status last verified
- Jan 2014
- First submitted
- 22 Nov 2012
- Last updated
- 17 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mitchell WK, Phillips BE, Williams JP, Rankin D, Lund JN, Smith K, Atherton PJ. A dose- rather than delivery profile-dependent mechanism regulates the "muscle-full" effect in response to oral essential amino acid intake in young men. J Nutr. 2015 Feb;145(2):207-14. doi: 10.3945/jn.114.199604. Epub 2014 Dec 10.
PubMed 25644339
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysfunction of Nutritive Blood Flow as a Determinant of Anabolic Resistance in Older People; The Role of Essential Amino Acids in Modulating Muscle Protein Metabolism; Bolus vs. Pulse Feeding Strategies and the Ability of Arginine to Rejuvenate Microvascular Responsiveness.
- ClinicalTrials.gov ID
- NCT01735539
- Acronym / sponsor ID
- Ajinomoto1A / UNottingham F/3/2009
- Keywords
- old age, sarcopenia, essential amino acid, arginine, contrast enhanced ultrasound, muscle microcirculation, muscle protein synthesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (estimated)
- First posted
- 28 Nov 2012 (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 investigators plan to measure changes in muscle protein metabolism in response to feeding, comparing between a single large essential amino acid (EAA) feed (the normal building blocks of protein) and the provision of the same dose in 4 smaller feeds at 45min intervals. The investigators will perform this study in healthy older (65-75y) and younger (18-28) men. The investigators will also explore how feeding affects muscle blood flow as this is important in the delivery of the nutrients we eat to the muscle where they are used.
The investigators plan to supplement the feed with arginine, a safe and widely found non-essential amino acid, to explore if this can improve muscle blood flow.
Detailed description
We will provide a 15g mixed essential amino acid feed or 4 x 3.75g.
There is sexual dimorphism thus initially we will just recruit males. Powering calculations dictate n=8 in each group.
We will use well established stable isotope tracer techniques (with 13C6 Phenylalanine) to measure muscle protein synthesis and breakdown by Gas Chromatography - combustion - isotope ratio mass spectroscopy.
We will measure leg blood flow by phase shift Doppler and muscle microvascular flow by contrast enhanced ultrasound.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Old Bolus | Experimental | Dietary Supplement: 15g EAA bolus15g EAA bolus |
| Old Arginine | Experimental | Dietary Supplement: 15g EAA Bolus supplemented with 3g Arginine15g EAA Bolus supplemented with 3g Arginine |
| Young Bolus | Experimental | Dietary Supplement: 15g EAA bolus15g EAA bolus |
| Young Pulse | Experimental | Dietary Supplement: 4 x 3.75g Mixed EAA Pulses4 x 3.75g Mixed EAA Pulses |
| Old Pulse | Experimental | Dietary Supplement: 4 x 3.75g Mixed EAA Pulses4 x 3.75g Mixed EAA Pulses |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age 65-75 or 18-28
Key exclusion criteria (4 listed)
- BMI >30
- Diabetes
- Beta blocker or steroid use
- Established cerebrovascular, peripheral vascular or ischaemic heart disease.
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 |
|---|---|---|
| 15g EAA bolusAlso: Mixed Essential Amino AcidsOral; in aqueous solution | Dietary supplement | Old Bolus, Young Bolus |
| 4 x 3.75g Mixed EAA PulsesOral; in aqueous solution | Dietary supplement | Old Pulse, Young Pulse |
| 15g EAA Bolus supplemented with 3g ArginineOral; in aqueous solution | Dietary supplement | Old Arginine |
Primary outcome
Muscle Protein Synthesis (FSR, fractional synthetic rate, %/hr)
Time frame: Across 6hr study
We measure FSR when fasted and again 0-90, 90-180 and 180-240 post feed.
3 secondary outcomes
Muscle Protein Breakdown (MPB)
Time frame: Across 6hr study
Whole leg blood flow
Time frame: Across a 6hr study
Muscle Microvascular Blood flow
Time frame: Across a 6hr study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2014.
- Derived from this study: PubMed 25644339Mitchell WK, Phillips BE, Williams JP, Rankin D, Lund JN, Smith K, Atherton PJ. A dose- rather than delivery profile-dependent mechanism regulates the "muscle-full" effect in response to oral essential amino acid intake in young men. J Nutr. 2015 Feb;145(2):207-14. doi: 10.3945/jn.114.199604. Epub 2014 Dec 10.
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.
Philip J Atherton, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 15g EAA bolus, 4 x 3.75g Mixed EAA Pulses and 15g EAA Bolus supplemented with 3g Arginine in people with Old Age (Focus; Not a Recognized Condition), run by University of Nottingham 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Jan 2014. 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?
Results are not available in the source record.
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, fractional synthetic rate, %/hr) (time frame: Across 6hr study). 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 NCT01735539, which also lists 1 linked publication.
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 Jan 2014.