Amino Acid MetabolismNCT03301337
Amino-acid Uptake After Meat Protein Intake
A study testing Meat protein absorption in people with Amino Acid Metabolism, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The purpose of the project is to provide evidence for the use of hydrolysed meat protein (HMP) as a protein supplement for elderly who has difficulty meeting the recommended daily protein intake. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amino Acid Metabolism
- What is being tested?
- Meat protein absorption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Oct 2017to 30 Oct 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy
- Untrained
Who cannot join
- below 65 years of age
- BMI above 30
- Smokers
- Vegetarians
- Subjects with diabetes or other metabolic diseases
- Medical treatment affecting protein synthesis
- Gastro-intestinal problems, reduced liver or kidney function, elevated blood pressure, atherosclerosis
- More than 5 ours regular physical activity per week (except physical activity related to commuting)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Amino-acid Uptake After Hydrolyzed Meat Protein Intake in Healthy Elderly
The purpose of the project is to provide evidence for the use of hydrolysed meat protein (HMP) as a protein supplement for elderly who has difficulty meeting the recommended daily protein intake.
The study will investigate how the meat protein derived amino acids (from either HMP, steak or minced meat) are absorbed and released into the blood circulation of elderly persons. Hereby, the study will explore the the anabolic potential of HMP compared with common meat products.
- Conditions
- Amino Acid Metabolism
- Being tested
- Meat protein absorption
- Keywords
- Amino acid uptake, Aging, Meat protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meat protein absorptionDietary supplement
Meat protein absorption when digested together with a full meal.
| Study group | Role | What they receive |
|---|---|---|
| Hydrolyzed meat protein | Experimental | D5-phenylalanine intrinsically labelled hydrolyzed meat protein (0.6 g per kg lean body mass), which will be consumed together with a full meal. Receives: Dietary Supplement: Meat protein absorption |
| Minced Meat | Experimental | D5-phenylalanine intrinsically labelled hydrolyzed meat protein (0.6 g per kg lean body mass), which will be consumed together with a full meal. Receives: Dietary Supplement: Meat protein absorption |
| Beef | Experimental | D5-phenylalanine intrinsically labelled hydrolyzed meat protein (0.6 g per kg lean body mass), which will be consumed together with a full meal. Receives: Dietary Supplement: Meat protein absorption |
What is being measured
The primary outcome is the main question the study is designed to answer.
D5-phenylalanine appearance
D5-phenylalanine appearance in the blood circulation after meal consumption
Measured: 5 hours
Secondary outcomes (1)
Insulin concentration
Insulin concentration in the blood circulation after meal consumption
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start4 Oct 2017
- Primary completion30 Jan 2018
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amino Acid MetabolismStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-blindet randomized cross-over study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- DC Ingredients
- Responsible party
- Principal investigator, Jakob Agergaard, Bispebjerg Hospital
- Investigators
- Jakob Agergaard, PhD, Principal investigator, Institute of Sports Medicine, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301337
- Sponsor's protocol ID
- BBH 135
- Status last verified
- Nov 2022
- First submitted
- 28 Sep 2017
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Amino-acid Uptake After Hydrolyzed Meat Protein Intake in Healthy Elderly
- ClinicalTrials.gov ID
- NCT03301337
- Acronym / sponsor ID
- BBH 135
- Conditions
- Amino Acid Metabolism
- Keywords
- Amino acid uptake, Aging, Meat protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- DC Ingredients
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 4 Oct 2017 (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 purpose of the project is to provide evidence for the use of hydrolysed meat protein (HMP) as a protein supplement for elderly who has difficulty meeting the recommended daily protein intake.
The study will investigate how the meat protein derived amino acids (from either HMP, steak or minced meat) are absorbed and released into the blood circulation of elderly persons. Hereby, the study will explore the the anabolic potential of HMP compared with common meat products.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Single-blindet randomized cross-over study
| Arm | Type | Receives |
|---|---|---|
| Hydrolyzed meat protein | Experimental | Dietary Supplement: Meat protein absorptionD5-phenylalanine intrinsically labelled hydrolyzed meat protein (0.6 g per kg lean body mass), which will be consumed together with a full meal. |
| Minced Meat | Experimental | Dietary Supplement: Meat protein absorptionD5-phenylalanine intrinsically labelled hydrolyzed meat protein (0.6 g per kg lean body mass), which will be consumed together with a full meal. |
| Beef | Experimental | Dietary Supplement: Meat protein absorptionD5-phenylalanine intrinsically labelled hydrolyzed meat protein (0.6 g per kg lean body mass), which will be consumed together with a full meal. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Healthy
- Untrained
Key exclusion criteria (8 listed)
- below 65 years of age
- BMI above 30
- Smokers
- Vegetarians
- Subjects with diabetes or other metabolic diseases
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 |
|---|---|---|
| Meat protein absorptionMeat protein absorption when digested together with a full meal. | Dietary supplement | Beef, Hydrolyzed meat protein, Minced Meat |
Primary outcome
D5-phenylalanine appearance
Time frame: 5 hours
D5-phenylalanine appearance in the blood circulation after meal consumption
1 secondary outcome
Insulin concentration
Time frame: 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 21 Nov 2022.
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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.
Jakob Agergaard, PhD principal investigator
Institute of Sports Medicine, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meat protein absorption in people with Amino Acid Metabolism, 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. 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?
D5-phenylalanine appearance (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 21 Nov 2022.