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Influence of Carbohydrate on Amino Acid Absorption From Dietary Protein (ICADP) (ICADP)

This study is currently recruiting participants.
Verified November 2017 by Lars Holm, Bispebjerg Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03303729
First Posted: October 6, 2017
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of Birmingham
Information provided by (Responsible Party):
Lars Holm, Bispebjerg Hospital
  Purpose

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.


Condition Intervention
Muscle Protein Synthesis Amino Acid Dietary Supplement: Meat Hydrolysate Dietary Supplement: Cluster Dextrin Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Influence of Carbohydrate on Amino Acid Absorption From Dietary Protein

Resource links provided by NLM:


Further study details as provided by Lars Holm, Bispebjerg Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.

  • 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

  • Insulin concentration [ Time Frame: From hour 0 to hour 3 ]
    Difference between insulin concentrations after intake of the two carbohydrate types.


Estimated Enrollment: 10
Anticipated Study Start Date: November 2017
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Meat hydrolysate & Cluster Dextrin
Meat hydrolysate containing 25g of protein given together with 75 grams of Cluster Dextrin.
Dietary Supplement: Meat Hydrolysate
25 grams of meat hydrolysate to maximally stimulate protein synthesis.
Dietary Supplement: Cluster Dextrin
75 grams of Cluster Dextrin
Other Names:
  • CAS no.: 9050-36-6
  • Glico Nutrition Co., Ltd.
Active Comparator: Meat hydrolysate & placebo
Meat hydrolysate containing 25g of protein given together with 75 grams of Glucose.
Dietary Supplement: Meat Hydrolysate
25 grams of meat hydrolysate to maximally stimulate protein synthesis.
Dietary Supplement: Placebo
75 grams of Glucose
Other Name: Glucose

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03303729


Contacts
Contact: Jacob L. Bülow, MD +453863566 jacob.bulow@live.dk
Contact: Mikkel Jensen, Stud.scient. +4522470243 m.jensen89@live.fk

Locations
Denmark
Bispebjerg Hospital Recruiting
Copenhagen, Copenhagen NV, Denmark, 2400
Contact: Jacob L. Bülow, MD    +45 38635366    jabob.bulow@live.dk   
Contact: Mikkel Jensen, Stud.    +4522470243    m.jensen89@live.dk   
Principal Investigator: Jacob L. Bülow, MD         
Sponsors and Collaborators
Bispebjerg Hospital
University of Birmingham
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
  More Information

Responsible Party: Lars Holm, PhD, MSc, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT03303729     History of Changes
Other Study ID Numbers: H-17017363
First Submitted: October 3, 2017
First Posted: October 6, 2017
Last Update Posted: November 6, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lars Holm, Bispebjerg Hospital:
Carbohydrate
Cluster Dextrin
Exercise training
Protein supplement