Muscle MassNCT03870425
Distribution of Nutrient Derived Amino Acids
A study testing Distribution pattern of dietary proteins (minced meat) in people with Muscle Mass and Protein Intake, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The project examines over several days how the distribution pattern of dietary protein stimulate and affect the protein turnover of important proteins in the aging perspective, such as skeletal muscle proteins. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Mass, Protein Intake, Diet Modification
- What is being tested?
- Distribution pattern of dietary proteins (minced meat)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Apr 2019to 28 Feb 2022
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Men and women
- Between 65-80 years of age
Who cannot join
- BMI above 30
- Smokers
- Vegetarians
- Diabetes or other metabolic diseases
- Medical treatment which affects protein turnover
- Gastro-intestinal diseases, reduced kidney or liver function, or chronic inflammation diseases
- Elevated blood-pressure or signs of atherosclerosis
- More than 5 hours of regular exercise each week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Distribution of Nutrient Derived Amino Acids and Anabolic Effect in Healthy Elderly Individuals
The project examines over several days how the distribution pattern of dietary protein stimulate and affect the protein turnover of important proteins in the aging perspective, such as skeletal muscle proteins.
- Conditions
- Muscle Mass, Protein Intake, Diet Modification, Protein Synthesis, Protein Breakdown, Sarcopenia
- Being tested
- Distribution pattern of dietary proteins (minced meat)
- Keywords
- Dietary protein, Sarcopenia, Protein turnover, Muscle protein
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distribution pattern of dietary proteins (minced meat)Other
Study effect of an even or skewed distribution pattern of dietary protein
| Study group | Role | What they receive |
|---|---|---|
| MINCED-SKEWED | Placebo comparator | Minced meat administered with a skewed protein distribution pattern Receives: Other: Distribution pattern of dietary proteins (minced meat) |
| MINCED-EVEN | Experimental | Minced meat administered with an even protein distribution pattern Receives: Other: Distribution pattern of dietary proteins (minced meat) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein synthesis
Myofibrillar FSR measured by deuterated water technique, by which deuterium labeled alanine incorporation into myofibrillar muscle protein synthesis can be measured.
Measured: 3 days
Net protein balance
Whole body net protein balance measured during 10 hours acute study. Measured by the application of stable amino acid labeled phenylalanine and tyrosine tracers, by which the protein synthesis, phenylalanine oxidation and protein breakdown can be calculated.
Measured: 10 hours
Secondary outcomes (8)
D5-phenylalanine incorporation
D5-phenylalanine incorporation into myofibrillar proteins. Dietary meat proteins are intrinsically labeled with D5-phenylalanine
Measured: 3 days
Muscle protein synthesis
Myofibrillar protein synthesis (%/hour) measured during 10 hours of the acute study. Calculated from the difference in D8-phenylalanine incorporation from the muscle biopsies taken at 2 hours and 12 hours into the stable amino acid tracer infusion.
Measured: 10 hours
Protein synthesis
Whole body protein synthesis (%/hour) measured during acute study, by the use of stabel amino acid tracer technique.
Measured: 10 hours
Protein breakdown
Whole body protein breakdown (%/hour) measured during acute study, by the use of stabel amino acid tracer technique.
Measured: 10 hours
Phenylalanine oxidation
Phenylalanine oxidation measured during acute study
Measured: 10 hours
D5-phenylalanine appearance
Plasma D5-phenylalanine enrichment after intake of D5-phenylalanine intrinsically labelled meat proteins
Measured: 12 hours
Signaling pathways in skeletal muscle
Intracellular signaling pathways related to protein turnover. Measured by Western blotting technique from the muscle tissue biopsies taken at 2 hours and 12 hours into the acute study.
Measured: 10 hours
Plasma insulin
Plasma insulin concentration during acute study
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start9 Apr 2019
- Primary completion30 Jun 2020
- Study completion28 Feb 2022
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 Muscle MassStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakob Agergaard, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870425
- Sponsor's protocol ID
- BBH 140
- Status last verified
- Nov 2022
- First submitted
- 18 Jan 2019
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agergaard J, Justesen TEH, Jespersen SE, Tagmose Thomsen T, Holm L, van Hall G. Even or skewed dietary protein distribution is reflected in the whole-body protein net-balance in healthy older adults: A randomized controlled trial. Clin Nutr. 2023 Jun;42(6):899-908. doi: 10.1016/j.clnu.2023.04.004. Epub 2023 Apr 8.
PubMed 37086618
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distribution of Nutrient Derived Amino Acids and Anabolic Effect in Healthy Elderly Individuals
- ClinicalTrials.gov ID
- NCT03870425
- Acronym / sponsor ID
- BBH 140
- Conditions
- Muscle Mass, Protein Intake, Diet Modification, Protein Synthesis, Protein Breakdown, Sarcopenia
- Keywords
- Dietary protein, Sarcopenia, Protein turnover, Muscle protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 12 Mar 2019 (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 project examines over several days how the distribution pattern of dietary protein stimulate and affect the protein turnover of important proteins in the aging perspective, such as skeletal muscle proteins.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled
| Arm | Type | Receives |
|---|---|---|
| MINCED-SKEWED | Placebo comparator | Other: Distribution pattern of dietary proteins (minced meat)Minced meat administered with a skewed protein distribution pattern |
| MINCED-EVEN | Experimental | Other: Distribution pattern of dietary proteins (minced meat)Minced meat administered with an even protein distribution pattern |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Men and women
- Between 65-80 years of age
Key exclusion criteria (8 listed)
- BMI above 30
- Smokers
- Vegetarians
- Diabetes or other metabolic diseases
- Medical treatment which affects protein turnover
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 |
|---|---|---|
| Distribution pattern of dietary proteins (minced meat)Study effect of an even or skewed distribution pattern of dietary protein | Other | MINCED-EVEN, MINCED-SKEWED |
Primary outcome
Muscle protein synthesis
Time frame: 3 days
Myofibrillar FSR measured by deuterated water technique, by which deuterium labeled alanine incorporation into myofibrillar muscle protein synthesis can be measured.
Net protein balance
Time frame: 10 hours
Whole body net protein balance measured during 10 hours acute study. Measured by the application of stable amino acid labeled phenylalanine and tyrosine tracers, by which the protein synthesis, phenylalanine oxidation and protein breakdown can be calculated.
8 secondary outcomes
D5-phenylalanine incorporation
Time frame: 3 days
Muscle protein synthesis
Time frame: 10 hours
Protein synthesis
Time frame: 10 hours
Protein breakdown
Time frame: 10 hours
Phenylalanine oxidation
Time frame: 10 hours
D5-phenylalanine appearance
Time frame: 12 hours
Signaling pathways in skeletal muscle
Time frame: 10 hours
Plasma insulin
Time frame: 12 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 21 Nov 2022.
- Derived from this study: PubMed 37086618Agergaard J, Justesen TEH, Jespersen SE, Tagmose Thomsen T, Holm L, van Hall G. Even or skewed dietary protein distribution is reflected in the whole-body protein net-balance in healthy older adults: A randomized controlled trial. Clin Nutr. 2023 Jun;42(6):899-908. doi: 10.1016/j.clnu.2023.04.004. Epub 2023 Apr 8.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distribution pattern of dietary proteins (minced meat) in people with Muscle Mass and Protein Intake, run by Bispebjerg Hospital 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 2 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 21 Nov 2022. 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. 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 protein synthesis (time frame: 3 days). The study lists 2 primary outcomes in all. 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 NCT03870425, 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 21 Nov 2022.