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

• Sponsor: Bispebjerg Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03303729
• Collaborator: University of Birmingham (Other)
• Enrollment: 10
• Location: 1
• Arms: 2
• Actual Duration (Months): 3
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief 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:

1. 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.

2. The meat hydrolysate will increase the protein synthesis rate to a higher extent when combined with cluster dextrin than with glucose.

Condition or Disease	Intervention/Treatment	Phase
Muscle Protein Synthesis; Amino Acid	Dietary Supplement: Meat Hydrolysate; Dietary Supplement: Cluster Dextrin; Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• 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
• Actual Study Start Date: Nov 24, 2017
• Actual Primary Completion Date: Feb 23, 2018
• Actual Study Completion Date: Feb 23, 2018

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Glucose

Outcome Measures

Primary Outcome Measures

1. Protein hydrolysate amino acid label time to peak appearance in plasma [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

1. Myofibrillar protein fractional synthesis rate response to protein and carbohydrate intake after a whole body resistance exercise [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.

2. Protein hydrolysate amino acid label area under the concentration curve in plasma [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

3. Insulin concentration [From hour 0 to hour 3]

   Difference between insulin concentrations after intake of the two carbohydrate types.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Bispebjerg Hospital	Copenhagen	Copenhagen NV	Denmark	2400

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lars Holm, PhD, MSc, Bispebjerg Hospital
• ClinicalTrials.gov Identifier: NCT03303729
• Other Study ID Numbers: H-17017363
• First Posted: Oct 6, 2017
• Last Update Posted: Feb 27, 2018
• Last Verified: Feb 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lars Holm, PhD, MSc, Bispebjerg Hospital: Carbohydrate; Cluster Dextrin; Exercise training; Protein supplement

Study Results

No Results Posted as of Feb 27, 2018