Meat Protein SupplementsNCT02732353
Absorption and Muscle-stimulating Effect of Hydrolyzed and Minced Beef
A study testing Minced beef and Hydrolyzed beef in people with Meat Protein Supplements and Protein Absorption and Amino Acid Availability, run by Kasper Dideriksen at 1 site in Denmark.
Trial summary
To measure the absorption kinetics and postprandial amino acid availability after ingestion of minced beef compared with hydrolyzed beef in young males. Moreover, the basal muscle protein synthesis and the postprandial muscle protein synthetic response to minced beef and hydrolyzed beef ingestion are measured in young… Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Meat Protein Supplements, Protein Absorption and Amino Acid Availability, Muscle Protein Synthesis
- What is being tested?
- Minced beef and Hydrolyzed beef
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2016to Mar 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Non-obese (BMI<30)
Who cannot join
- Chronic medical disease
- >5 hour of exercise weekly, except light activities such as stretching/gymnastics and bike-riding/walking as transportation
Trial locations and contacts
1 site in 1 country.
Lars Holm, PhD contact
Denmark1 site
Bispebjerg Hospital
Copenhagen NV, 2400
Kasper Dideriksen, PhD, +45 35313948, kasperjuel@hotmail.com
Kasper Dideriksen, PhD
About this study
To measure the absorption kinetics and postprandial amino acid availability after ingestion of minced beef compared with hydrolyzed beef in young males. Moreover, the basal muscle protein synthesis and the postprandial muscle protein synthetic response to minced beef and hydrolyzed beef ingestion are measured in young males. The postprandial muscle protein synthetic response is measured and compared during the early postprandial period (0-3 hours) after ingestion of the two meat products.
- Conditions
- Meat Protein Supplements, Protein Absorption and Amino Acid Availability, Muscle Protein Synthesis
- Being tested
- Minced beef, Hydrolyzed beef
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minced beefDietary supplement
Cow meat protein supplement
Hydrolyzed beefDietary supplement
Cow meat protein supplement
| Study group | Role | What they receive |
|---|---|---|
| Minced beef | Active comparator | Minced beef Receives: Dietary Supplement: Minced beef |
| Hydrolyzed beef | Experimental | Hydrolyzed beef Receives: Dietary Supplement: Hydrolyzed beef |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skeletal muscle protein fractional synthetic rate
The fractional synthetic rate of skeletal muscle proteins (%/h) measured during the overnight fasted state and the postprandial state.
Measured: During the postprandial period (0-3 hrs).
Secondary outcomes (2)
Protein absorption
The change in venous plasma ring-2H5-phenylalanine enrichment after ingestion of meat protein, reflects the protein absorption from the meat protein products.
Measured: During the postprandial period (0-3 hrs).
Plasma amino acid concentration
Change in venous plasma amino acid concentration after ingestion of meat protein.
Measured: During the postprandial period (0-3 hrs).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meat Protein SupplementsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasper Dideriksen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kasper Dideriksen, Bispebjerg Hospital
- Investigators
- Kasper Dideriksen, PhD, Principal investigator, Bispebjerg HospitalLars Holm, PhD, Principal investigator, Bispebjerg HospitalSøren Reitelseder, PhD, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732353
- Sponsor's protocol ID
- H-15012327
- Status last verified
- Nov 2016
- First submitted
- 30 Mar 2016
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorption and Muscle-stimulating Effect of Hydrolyzed and Minced Beef
- ClinicalTrials.gov ID
- NCT02732353
- Acronym / sponsor ID
- H-15012327
- Conditions
- Meat Protein Supplements, Protein Absorption and Amino Acid Availability, Muscle Protein Synthesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Kasper DideriksenUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 8 Apr 2016 (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.
To measure the absorption kinetics and postprandial amino acid availability after ingestion of minced beef compared with hydrolyzed beef in young males. Moreover, the basal muscle protein synthesis and the postprandial muscle protein synthetic response to minced beef and hydrolyzed beef ingestion are measured in young males. The postprandial muscle protein synthetic response is measured and compared during the early postprandial period (0-3 hours) after ingestion of the two meat products.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minced beef | Active comparator | Dietary Supplement: Minced beefMinced beef |
| Hydrolyzed beef | Experimental | Dietary Supplement: Hydrolyzed beefHydrolyzed beef |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy
- Non-obese (BMI<30)
Key exclusion criteria (2 listed)
- Chronic medical disease
- >5 hour of exercise weekly, except light activities such as stretching/gymnastics and bike-riding/walking as transportation
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 |
|---|---|---|
| Minced beefCow meat protein supplement | Dietary supplement | Minced beef |
| Hydrolyzed beefCow meat protein supplement | Dietary supplement | Hydrolyzed beef |
Primary outcome
Change in skeletal muscle protein fractional synthetic rate
Time frame: During the postprandial period (0-3 hrs).
The fractional synthetic rate of skeletal muscle proteins (%/h) measured during the overnight fasted state and the postprandial state.
2 secondary outcomes
Protein absorption
Time frame: During the postprandial period (0-3 hrs).
Plasma amino acid concentration
Time frame: During the postprandial period (0-3 hrs).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- Individual participant dataSharing planned: No
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.
Lars Holm, PhD contact
Kasper Dideriksen, PhD principal investigator
Bispebjerg Hospital
Lars Holm, PhD principal investigator
Bispebjerg Hospital
Søren Reitelseder, PhD principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minced beef and Hydrolyzed beef in people with Meat Protein Supplements and Protein Absorption and Amino Acid Availability, run by Kasper Dideriksen 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 2 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 8 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kasper Dideriksen, PhD (+45 35313948, kasperjuel@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in skeletal muscle protein fractional synthetic rate (time frame: During the postprandial period (0-3 hrs).). 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 8 Nov 2016.