- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03303729
Influence of Carbohydrate on Amino Acid Absorption From Dietary Protein (ICADP) (ICADP)
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.
Hypotheses:
I) 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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Copenhagen NV
-
Copenhagen, Copenhagen NV, Denmark, 2400
- Bispebjerg Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- young healthy adults,
- organised sport/training 1-3 times per week
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Meat hydrolysate & Cluster Dextrin
Meat hydrolysate containing 25g of protein given together with 75 grams of Cluster Dextrin.
|
25 grams of meat hydrolysate to maximally stimulate protein synthesis.
75 grams of Cluster Dextrin
Other Names:
|
|
Active Comparator: Meat hydrolysate & placebo
Meat hydrolysate containing 25g of protein given together with 75 grams of Glucose.
|
25 grams of meat hydrolysate to maximally stimulate protein synthesis.
75 grams of Glucose
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
From hour 0 to hour 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Difference between myofibrillar protein fractional synthesis rate after meat hydrolysate with either 75 grams of Cluster Dextrin or Clucose.
|
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
|
Difference between the area under the concentration curve of protein-derived D5-phenylalanine amino acid appearance in the plasma
|
From hour 0 to hour 3
|
|
Insulin concentration
Time Frame: From hour 0 to hour 3
|
Difference between insulin concentrations after intake of the two carbohydrate types.
|
From hour 0 to hour 3
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jacob L. Bülow, MD, Bispebjerg Hospital
- Principal Investigator: Lars Holm, Prof., University of Birmingham
- Principal Investigator: Michael Kjaer, MD, prof., Bispebjerg Hospital
- Principal Investigator: Sofus Sølyst, stud.med., University of Copenhagen
- Principal Investigator: Mikkel Jensen, Stud.scient., University of Copenhagen
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H-17017363
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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