NCT03303729

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: 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 24, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2018

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

3 months

First QC Date

October 3, 2017

Last Update Submit

February 26, 2018

Conditions

Keywords

CarbohydrateCluster DextrinExercise trainingProtein supplement

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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.

  • Protein hydrolysate amino acid label area under the concentration curve in plasma

    From hour 0 to hour 3

  • Insulin concentration

    From hour 0 to hour 3

Study Arms (2)

Meat hydrolysate & Cluster Dextrin

EXPERIMENTAL

Meat hydrolysate containing 25g of protein given together with 75 grams of Cluster Dextrin.

Dietary Supplement: Meat HydrolysateDietary Supplement: Cluster Dextrin

Meat hydrolysate & placebo

ACTIVE COMPARATOR

Meat hydrolysate containing 25g of protein given together with 75 grams of Glucose.

Dietary Supplement: Meat HydrolysateDietary Supplement: Placebo

Interventions

Meat HydrolysateDIETARY_SUPPLEMENT

25 grams of meat hydrolysate to maximally stimulate protein synthesis.

Meat hydrolysate & Cluster DextrinMeat hydrolysate & placebo
Cluster DextrinDIETARY_SUPPLEMENT

75 grams of Cluster Dextrin

Also known as: CAS no.: 9050-36-6, Glico Nutrition Co., Ltd.
Meat hydrolysate & Cluster Dextrin
PlaceboDIETARY_SUPPLEMENT

75 grams of Glucose

Also known as: Glucose
Meat hydrolysate & placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • young healthy adults,
  • organised sport/training 1-3 times per week

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, Copenhagen NV, 2400, Denmark

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Long-Term Synaptic DepressionGlucose

Intervention Hierarchy (Ancestors)

Neuronal PlasticityNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MSc

Study Record Dates

First Submitted

October 3, 2017

First Posted

October 6, 2017

Study Start

November 24, 2017

Primary Completion

February 23, 2018

Study Completion

February 23, 2018

Last Updated

February 27, 2018

Record last verified: 2018-02

Locations