Muscle Protein SynthesisICADPNCT03303729
Influence of Carbohydrate on Amino Acid Absorption From Dietary Protein (ICADP)
A study testing Meat Hydrolysate and Cluster Dextrin in people with Muscle Protein Synthesis and Amino Acid, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
10 young males will be recruited to participate in a randomized double blinded crossover study to investigate the influence of concomitant intake of two different types of carbohydrate with protein hydrolysate on the absorption kinetics of protein-derived amino acids and the impact on myofibrillar protein synthesis. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Protein Synthesis, Amino Acid
- What is being tested?
- Meat Hydrolysate and Cluster Dextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Nov 2017to 23 Feb 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- young healthy adults,
- organised sport/training 1-3 times per week
Who cannot join
- Subject younger than 18 years or above 30 years
- BMI > 30
- Chronic medical diseases: active cancer, renal diseases, metabolic diseases like diabetes mellitus.
- Physical inactivity. Subjects must participate in systematized weekly exercise 1-3 times per week.
- Participating in systematized exercise more than 3 times per week.
- Vegetarian.
- Participating in a special diet which deviates from the standard of young adults.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Carbohydrate on Amino Acid Absorption From Dietary Protein
10 young males will be recruited to participate in a randomized double blinded crossover study to investigate the influence of concomitant intake of two different types of carbohydrate with protein hydrolysate on the absorption kinetics of protein-derived amino acids and the impact on myofibrillar protein synthesis. During the trial days the subjects will perform a bout of whole body resistance exercise and ingest a supplement of meat hydrolysate labeled with D5-phenylalanine together with randomized and double blinded type of carbohydrate consisting of either glucose or cluster dextrin.
The primary outcome is the time to obtain peak concentration of D5-phenylalanine after intake of meat hydrolysate with either glucose or cluster dextrin.
Read more
Hypotheses:
- The cluster dextrin will increase the absorption of the amino acids from the meat hydrolysate, and thereby result in a faster rise and a higher peak in plasma amino acid concentration in the postprandial period.
II) The meat hydrolysate will increase the protein synthesis rate to a higher extent when combined with cluster dextrin than with glucose.
- Conditions
- Muscle Protein Synthesis, Amino Acid
- Being tested
- Meat Hydrolysate, Cluster Dextrin, Placebo
- Keywords
- Carbohydrate, Cluster Dextrin, Exercise training, Protein supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meat HydrolysateDietary supplement
25 grams of meat hydrolysate to maximally stimulate protein synthesis.
Cluster DextrinDietary supplement
Also called CAS no.: 9050-36-6, Glico Nutrition Co., Ltd.
75 grams of Cluster Dextrin
PlaceboDietary supplement
Also called Glucose
75 grams of Glucose
| Study group | Role | What they receive |
|---|---|---|
| Meat hydrolysate & Cluster Dextrin | Experimental | Meat hydrolysate containing 25g of protein given together with 75 grams of Cluster Dextrin. Receives: Dietary Supplement: Meat Hydrolysate; Dietary Supplement: Cluster Dextrin |
| Meat hydrolysate & placebo | Active comparator | Meat hydrolysate containing 25g of protein given together with 75 grams of Glucose. Receives: Dietary Supplement: Meat Hydrolysate; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein hydrolysate amino acid label time to peak appearance in plasma
Difference between the time to peak of protein-derived D5-phenylalanine amino acid appearance in the plasma
Measured: From hour 0 to hour 3
Secondary outcomes (3)
Myofibrillar protein fractional synthesis rate response to protein and carbohydrate intake after a whole body resistance exercise
Difference between myofibrillar protein fractional synthesis rate after meat hydrolysate with either 75 grams of Cluster Dextrin or Clucose.
Measured: from hour 0,5 to hour hour 1. From hour 1 to hour 3. From hour 0,5 to hour 3.
Protein hydrolysate amino acid label area under the concentration curve in plasma
Difference between the area under the concentration curve of protein-derived D5-phenylalanine amino acid appearance in the plasma
Measured: From hour 0 to hour 3
Insulin concentration
Difference between insulin concentrations after intake of the two carbohydrate types.
Measured: From hour 0 to hour 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start24 Nov 2017
- Primary completion23 Feb 2018
- Study completion23 Feb 2018
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 Protein SynthesisStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham
- Responsible party
- Principal investigator, Lars Holm, Bispebjerg Hospital
- Investigators
- Jacob L. Bülow, MD, Principal investigator, Bispebjerg HospitalLars Holm, Prof., Principal investigator, University of BirminghamMichael Kjaer, MD, prof., Principal investigator, Bispebjerg HospitalSofus Sølyst, stud.med., Principal investigator, University of CopenhagenMikkel Jensen, Stud.scient., Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303729
- Sponsor's protocol ID
- H-17017363
- Acronym
- ICADP
- Status last verified
- Feb 2018
- First submitted
- 3 Oct 2017
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nishimura Y, Jensen M, Bulow J, Thomsen TT, Arimitsu T, van Hall G, Fujita S, Holm L. Co-ingestion of cluster dextrin carbohydrate does not increase exogenous protein-derived amino acid release or myofibrillar protein synthesis following a whole-body resistance exercise in moderately trained younger males: a double-blinded randomized controlled crossover trial. Eur J Nutr. 2022 Aug;61(5):2475-2491. doi: 10.1007/s00394-021-02782-y. Epub 2022 Feb 19.
PubMed 35182194
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Carbohydrate on Amino Acid Absorption From Dietary Protein
- ClinicalTrials.gov ID
- NCT03303729
- Acronym / sponsor ID
- ICADP / H-17017363
- Conditions
- Muscle Protein Synthesis, Amino Acid
- Keywords
- Carbohydrate, Cluster Dextrin, Exercise training, Protein supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- University of Birmingham
- Study start
- 24 Nov 2017 (actual)
- Primary completion
- 23 Feb 2018 (actual)
- Study completion
- 23 Feb 2018 (actual)
- First posted
- 6 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.
10 young males will be recruited to participate in a randomized double blinded crossover study to investigate the influence of concomitant intake of two different types of carbohydrate with protein hydrolysate on the absorption kinetics of protein-derived amino acids and the impact on myofibrillar protein synthesis. During the trial days the subjects will perform a bout of whole body resistance exercise and ingest a supplement of meat hydrolysate labeled with D5-phenylalanine together with randomized and double blinded type of carbohydrate consisting of either glucose or cluster dextrin.
The primary outcome is the time to obtain peak concentration of D5-phenylalanine after intake of meat hydrolysate with either glucose or cluster dextrin.
Hypotheses:
- The cluster dextrin will increase the absorption of the amino acids from the meat hydrolysate, and thereby result in a faster rise and a higher peak in plasma amino acid concentration in the postprandial period.
II) The meat hydrolysate will increase the protein synthesis rate to a higher extent when combined with cluster dextrin than with glucose.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meat hydrolysate & Cluster Dextrin | Experimental | Dietary Supplement: Meat Hydrolysate, Dietary Supplement: Cluster DextrinMeat hydrolysate containing 25g of protein given together with 75 grams of Cluster Dextrin. |
| Meat hydrolysate & placebo | Active comparator | Dietary Supplement: Meat Hydrolysate, Dietary Supplement: PlaceboMeat hydrolysate containing 25g of protein given together with 75 grams of Glucose. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- young healthy adults,
- organised sport/training 1-3 times per week
Key exclusion criteria (7 listed)
- Subject younger than 18 years or above 30 years
- BMI > 30
- Chronic medical diseases: active cancer, renal diseases, metabolic diseases like diabetes mellitus.
- Physical inactivity. Subjects must participate in systematized weekly exercise 1-3 times per week.
- Participating in systematized exercise more than 3 times per week.
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 Hydrolysate25 grams of meat hydrolysate to maximally stimulate protein synthesis. | Dietary supplement | Meat hydrolysate & Cluster Dextrin, Meat hydrolysate & placebo |
| Cluster DextrinAlso: CAS no.: 9050-36-6, Glico Nutrition Co., Ltd.75 grams of Cluster Dextrin | Dietary supplement | Meat hydrolysate & Cluster Dextrin |
| PlaceboAlso: Glucose75 grams of Glucose | Dietary supplement | Meat hydrolysate & placebo |
Primary outcome
Protein hydrolysate amino acid label time to peak appearance in plasma
Time frame: From hour 0 to hour 3
Difference between the time to peak of protein-derived D5-phenylalanine amino acid appearance in the plasma
3 secondary outcomes
Myofibrillar protein fractional synthesis rate response to protein and carbohydrate intake after a whole body resistance exercise
Time frame: from hour 0,5 to hour hour 1. From hour 1 to hour 3. From hour 0,5 to hour 3.
Protein hydrolysate amino acid label area under the concentration curve in plasma
Time frame: From hour 0 to hour 3
Insulin concentration
Time frame: From hour 0 to hour 3
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 27 Feb 2018.
- Derived from this study: PubMed 35182194Nishimura Y, Jensen M, Bulow J, Thomsen TT, Arimitsu T, van Hall G, Fujita S, Holm L. Co-ingestion of cluster dextrin carbohydrate does not increase exogenous protein-derived amino acid release or myofibrillar protein synthesis following a whole-body resistance exercise in moderately trained younger males: a double-blinded randomized controlled crossover trial. Eur J Nutr. 2022 Aug;61(5):2475-2491. doi: 10.1007/s00394-021-02782-y. Epub 2022 Feb 19.
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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.
Jacob L. Bülow, MD principal investigator
Bispebjerg Hospital
Lars Holm, Prof. principal investigator
University of Birmingham
Michael Kjaer, MD, prof. 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 Meat Hydrolysate and Cluster Dextrin in people with Muscle Protein Synthesis and Amino Acid, 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 7 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 27 Feb 2018. 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?
Protein hydrolysate amino acid label time to peak appearance in plasma (time frame: From hour 0 to hour 3). 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 NCT03303729, 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 27 Feb 2018.