ElderlyNCT02620111
Protein Balance in Protein Supplemented Elderly Patients: Acute Study With Protein-tracer-techniques
A study testing Whey protein high in leucin and Whey protein normal in leucin in people with Elderly, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of this study is to investigate potential protein synthesis effects of whey protein high in leucine compared to whey protein with normal leucin content in elderly patients in a acute crossover setting. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly
- What is being tested?
- Whey protein high in leucin and Whey protein normal in leucin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2015to Sep 2016
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy elder people
Who cannot join
- Liver and kidney disease.
- Known diabetes or Hgb1c ≥6,5% (≥48mmol/l).
- Severe heart disease (NYHA-Class >2).
- Oral corticosteroid treatment within the last 3 month.
- participation in other intervention studies within the last 4 weeks.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of endocrinology, Aarhus University hospital
Aarhus C, 8000
About this study
Official title: Effect of Protein High in Leucine on Muscle Protein Balance in Elderly Patients: Acute Study With Protein-tracer-techniques
The aim of this study is to investigate potential protein synthesis effects of whey protein high in leucine compared to whey protein with normal leucin content in elderly patients in a acute crossover setting. We will use the method of a 2 X 3 h tracer infusing protocol with 15Nphenylalanine along with blood samples and muscle biopsies.
Read the detailed description
Background: Improved muscle function/strength will enhance the quality of life of the more frail elderly population. Dietary proteins and amino acids act as anabolic substrates in muscles in elderly people. In particular the amino acid leucine is suggested to have an impact on muscle protein synthesis. In collaboration with the Danish dairy company Arla Foods we will use their conventional Whey protein and leucine enriched Whey protein in an acute study on elderly patients.
Our aim is to examine the acute effects of supplementation with whey protein high in leucine compared to whey protein with normal leucine content on muscle protein synthesis and protein balance in elderly patients.
Methods: We include 10 elderly patients, age 60-85 years in a randomized crossover study. The subjects will be recruited from the Osteoporosis Section at the Department of Endocrinology at Aarhus University Hospital. The subjects are their own controls in 2 x 1 day interventions A: whey protein high in leucine and B: whey protein with normal leucine content. Interventions are conducted with a 4 week washout period between them. On the intervention day postprandial protein synthesis rate will be measured over 2 X 3h using a tracer infusing protocol with 15Nphenylalanine along with blood samples and muscle biopsies. For analyzing steps of signaling in muscle protein synthesis initiated by leucine mammalian target of rapamycin (mTor) and sites downstream from mTor is quantified using western blotting. Whole body protein kinetics are calculated using the formula Q=i*Ei/Ep-i
- Conditions
- Elderly
- Being tested
- Whey protein high in leucin, Whey protein normal in leucin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey protein high in leucinDietary supplement
This Group is analysed for muscle protein synthesis and breakdown, mTor pathway signaling and Amino acid metabolism while supplemented first water then whey protein high in leucin
Whey protein normal in leucinDietary supplement
This Group is analysed for muscle protein synthesis and breakdown, mTor pathway signaling and Amino acid metabolism while supplemented first water then whey protein normal in leucin.
| Study group | Role | What they receive |
|---|---|---|
| Whey protein high leucine | Experimental | Subjects are supplemented water in a fasted state for 180 minutes while the isotopic tracer 15Nphenylalanin is infused. Subjects are supplemented with whey protein high in leucine from 180 - 360 minutes while the isotopic tracer 15Nphenylalanin is infused. Receives: Dietary Supplement: Whey protein high in leucin |
| Whey protein normal leucine | Active comparator | Subjects are supplemented water in a fasted state for 180 minutes while the isotopic tracer 15Nphenylalanin is infused. Subjects are supplemented with whey protein normal in leucine from 180 - 360 minutes while the isotopic tracer 15Nphenylalanin is infused. Receives: Dietary Supplement: Whey protein normal in leucin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein balance
Measured: Protein balance is measured in a triplet from 160-180 minutes into the protein supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2016 (estimated)
- Study completionSep 2016 (estimated)
Why it stopped: Due to difficulties in recruiting frail subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Council for Strategic Research, Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Jesper L Mehlsen, Phd student, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620111
- Sponsor's protocol ID
- 44853
- Status last verified
- Jun 2015
- First submitted
- 30 Nov 2015
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Protein High in Leucine on Muscle Protein Balance in Elderly Patients: Acute Study With Protein-tracer-techniques
- ClinicalTrials.gov ID
- NCT02620111
- Acronym / sponsor ID
- 44853
- Conditions
- Elderly
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to difficulties in recruiting frail subjects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Danish Council for Strategic Research, Aarhus University Hospital
- Study start
- Jun 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 2 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.
The aim of this study is to investigate potential protein synthesis effects of whey protein high in leucine compared to whey protein with normal leucin content in elderly patients in a acute crossover setting. We will use the method of a 2 X 3 h tracer infusing protocol with 15Nphenylalanine along with blood samples and muscle biopsies.
Detailed description
Background: Improved muscle function/strength will enhance the quality of life of the more frail elderly population. Dietary proteins and amino acids act as anabolic substrates in muscles in elderly people. In particular the amino acid leucine is suggested to have an impact on muscle protein synthesis. In collaboration with the Danish dairy company Arla Foods we will use their conventional Whey protein and leucine enriched Whey protein in an acute study on elderly patients.
Our aim is to examine the acute effects of supplementation with whey protein high in leucine compared to whey protein with normal leucine content on muscle protein synthesis and protein balance in elderly patients.
Methods: We include 10 elderly patients, age 60-85 years in a randomized crossover study. The subjects will be recruited from the Osteoporosis Section at the Department of Endocrinology at Aarhus University Hospital. The subjects are their own controls in 2 x 1 day interventions A: whey protein high in leucine and B: whey protein with normal leucine content. Interventions are conducted with a 4 week washout period between them. On the intervention day postprandial protein synthesis rate will be measured over 2 X 3h using a tracer infusing protocol with 15Nphenylalanine along with blood samples and muscle biopsies. For analyzing steps of signaling in muscle protein synthesis initiated by leucine mammalian target of rapamycin (mTor) and sites downstream from mTor is quantified using western blotting. Whole body protein kinetics are calculated using the formula Q=i*Ei/Ep-i
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whey protein high leucine | Experimental | Dietary Supplement: Whey protein high in leucinSubjects are supplemented water in a fasted state for 180 minutes while the isotopic tracer 15Nphenylalanin is infused. Subjects are supplemented with whey protein high in leucine from 180 - 360 minutes while the isotopic tracer 15Nphenylalanin is infused. |
| Whey protein normal leucine | Active comparator | Dietary Supplement: Whey protein normal in leucinSubjects are supplemented water in a fasted state for 180 minutes while the isotopic tracer 15Nphenylalanin is infused. Subjects are supplemented with whey protein normal in leucine from 180 - 360 minutes while the isotopic tracer 15Nphenylalanin is infused. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy elder people
Key exclusion criteria (5 listed)
- Liver and kidney disease.
- Known diabetes or Hgb1c ≥6,5% (≥48mmol/l).
- Severe heart disease (NYHA-Class >2).
- Oral corticosteroid treatment within the last 3 month.
- participation in other intervention studies within the last 4 weeks.
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 |
|---|---|---|
| Whey protein high in leucinThis Group is analysed for muscle protein synthesis and breakdown, mTor pathway signaling and Amino acid metabolism while supplemented first water then whey protein high in leucin | Dietary supplement | Whey protein high leucine |
| Whey protein normal in leucinThis Group is analysed for muscle protein synthesis and breakdown, mTor pathway signaling and Amino acid metabolism while supplemented first water then whey protein normal in leucin. | Dietary supplement | Whey protein normal leucine |
Primary outcome
Protein balance
Time frame: Protein balance is measured in a triplet from 160-180 minutes into the protein supplementation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- 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.
Jesper L Mehlsen, Phd student principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein high in leucin and Whey protein normal in leucin in people with Elderly, run by University of Aarhus at 1 site in Denmark.
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 5 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: withdrawn, as of the sponsor's last update on 25 Oct 2016. 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 Denmark. 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 was withdrawn before enrolling participants, so there are no results.
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?
Protein balance (time frame: Protein balance is measured in a triplet from 160-180 minutes into the protein supplementation). 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 25 Oct 2016.