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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03303729
Other study ID # H-17017363
Secondary ID
Status Completed
Phase N/A
First received October 3, 2017
Last updated February 26, 2018
Start date November 24, 2017
Est. completion date February 23, 2018

Study information

Verified date February 2018
Source Bispebjerg Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date February 23, 2018
Est. primary completion date February 23, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Meat Hydrolysate
25 grams of meat hydrolysate to maximally stimulate protein synthesis.
Cluster Dextrin
75 grams of Cluster Dextrin
Placebo
75 grams of Glucose

Locations

Country Name City State
Denmark Bispebjerg Hospital Copenhagen Copenhagen NV

Sponsors (2)

Lead Sponsor Collaborator
Bispebjerg Hospital University of Birmingham

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 From hour 0 to hour 3
Secondary 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. from hour 0,5 to hour hour 1. From hour 1 to hour 3. From hour 0,5 to hour 3.
Secondary 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 From hour 0 to hour 3
Secondary Insulin concentration Difference between insulin concentrations after intake of the two carbohydrate types. From hour 0 to hour 3
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