NCT01576848

Brief Summary

Rationale: Age related muscle loss (sarcopenia) is assumed to be related to the impaired postprandial muscle protein synthetic response to protein and/or amino acid administration in the elderly vs the young. Co-ingestion of carbohydrate increases post-prandial insulin secretion. Insulin affects skeletal muscle blood flow and may therefore affect substrate availability and postprandial muscle protein synthesis. However, it is unclear whether the response to the combined intake of protein and carbohydrates is different in elderly compared to young subjects. Hypothesis: Adding carbohydrate to a bolus of protein represents an effective strategy to overcome the impaired postprandial muscle protein synthesis in the elderly. Objective: The primary objective of the study is to investigate whether carbohydrate co-ingestion augments the in vivo postprandial muscle protein synthetic response after protein ingestion and whether this response is different between young and elderly subjects. The secondary objective of the study is to assess the effect of carbohydrate co-ingestion on insulin levels and microvascular perfusion in young and elderly subjects. Intervention: The intervention consists of a single test day during which the subjects will receive a drink containing 20 gram intrinsically labelled casein with or without 60 gram carbohydrates. In addition, continuous intravenous tracer infusions of labeled amino acids will be administered. During the test day 18 plasma samples and 4 muscle biopsies will be collected over a period of 8½ h. Furthermore, muscle skeletal blood flow will be estimated using sidestream darkfield imaging (SDF) in sublingual position.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2011

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

Study Start

First participant enrolled

August 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 13, 2012

Completed
Last Updated

April 13, 2012

Status Verified

April 1, 2012

Enrollment Period

7 months

First QC Date

August 9, 2011

Last Update Submit

April 12, 2012

Conditions

Keywords

muscle metabolismintrinsically labeled proteinprotein synthesisinsulinperfusion

Outcome Measures

Primary Outcomes (1)

  • Change from fasted state in Muscle protein synthesis rate (expressed as Fractional Synthetic Rate, FSR) at different time points postprandial

    Participants will be followed in a fasted state over 2 hours and in a postprandial state over 5 hours

Secondary Outcomes (4)

  • Change from fasted state in Whole body protein balance at different time ponits postprandial

    Participants will be followed in a fasted state over 2 hours and in a postprandial state over 5 hours

  • Change from fasted state in Microvascular perfusion at different time points postprandial

    Participants will be followed in a fasted state over 2 hours and in a postprandial state over 5 hours

  • Change from fasted state in Digestion kinetics of dietary intrinsically labeled protein at different time points postprandial

    Participants will be followed in a fasted state over 2 hours and in a postprandial state over 5 hours

  • Change from fasted state in Absorption kinetics of dietary intrinsically labeled protein at different time points postprandial

    Participants will be followed in a fasted state over 2 hours and in a postprandial state over 5 hours

Study Arms (4)

GROUP 1 (OLD-PRO)

EXPERIMENTAL

test drink contains intrinsically labeled protein alone

Dietary Supplement: Protein

GROUP 2 (OLD-PRO/CARB)

EXPERIMENTAL

test drink contains intrinsically labeled protein and carbohydrate

Dietary Supplement: Protein + carbohydrate

GROUP 3 (YOUNG-PRO)

EXPERIMENTAL

test drink contains intrinsically labeled protein alone

Dietary Supplement: Protein

GROUP 4 (YOUNG-PRO/CARB)

EXPERIMENTAL

test drink contains intrinsically labeled protein and carbohydrate

Dietary Supplement: Protein + carbohydrate

Interventions

ProteinDIETARY_SUPPLEMENT

Subjects will receive a drink containing 20 gram intrinsically labelled casein. Half of the subject are young males (YOUNG)(age between 18 and 35 y) and half of the subjects are elderly males (OLD)(age between 70 and 85 y).

Also known as: Intrinsically labelled casein
GROUP 1 (OLD-PRO)GROUP 3 (YOUNG-PRO)
Protein + carbohydrateDIETARY_SUPPLEMENT

subjects will receive a drink containing 20 gram intrinsically labelled casein plus 60 gram carbohydrates. Half of the subject are young males (YOUNG)(age between 18 and 35 y) and half of the subjects are elderly males (OLD)(age between 70 and 85 y).

Also known as: Casein plus dextrose monohydrate and maltodextrin
GROUP 2 (OLD-PRO/CARB)GROUP 4 (YOUNG-PRO/CARB)

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males
  • Age 70-85 years or Age 18-30 years
  • BMI \< 30 kg∙m2

You may not qualify if:

  • Diabetes
  • HbA1c \> 7.0%
  • Obesity (BMI \> 30 kg/m2)
  • Diagnosed impaired renal or liver function
  • All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthrosis, arthritis, spasticity/rigidity, all neurological disorders and paralysis).
  • Hypertension (according to WHO criteria) (36)
  • Use of anticoagulants, blood diseases, allergy for lidocain
  • Use of NSAIDs and acetylsalicylic acid
  • Use of gastric acid inhibitors
  • Patients suffering from PKU (Phenylketonuria)
  • Participation in any regular exercise program
  • Unstable body weight over the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6200 MD, Netherlands

Location

Related Publications (3)

  • Gorissen SHM, Trommelen J, Kouw IWK, Holwerda AM, Pennings B, Groen BBL, Wall BT, Churchward-Venne TA, Horstman AMH, Koopman R, Burd NA, Fuchs CJ, Dirks ML, Res PT, Senden JMG, Steijns JMJM, de Groot LCPGM, Verdijk LB, van Loon LJC. Protein Type, Protein Dose, and Age Modulate Dietary Protein Digestion and Phenylalanine Absorption Kinetics and Plasma Phenylalanine Availability in Humans. J Nutr. 2020 Aug 1;150(8):2041-2050. doi: 10.1093/jn/nxaa024.

  • Kouw IW, Gorissen SH, Burd NA, Cermak NM, Gijsen AP, van Kranenburg J, van Loon LJ. Postprandial Protein Handling Is Not Impaired in Type 2 Diabetes Patients When Compared With Normoglycemic Controls. J Clin Endocrinol Metab. 2015 Aug;100(8):3103-11. doi: 10.1210/jc.2015-1234. Epub 2015 Jun 2.

  • Gorissen SH, Burd NA, Hamer HM, Gijsen AP, Groen BB, van Loon LJ. Carbohydrate coingestion delays dietary protein digestion and absorption but does not modulate postprandial muscle protein accretion. J Clin Endocrinol Metab. 2014 Jun;99(6):2250-8. doi: 10.1210/jc.2013-3970. Epub 2014 Mar 14.

MeSH Terms

Conditions

SarcopeniaInsulin Resistance

Interventions

ProteinsCarbohydratesCaseinsGlucosemaltodextrin

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and ProteinsMilk ProteinsAnimal Proteins, DietaryDietary ProteinsPhosphoproteinsHexosesMonosaccharidesSugars

Study Officials

  • Luc JC van Loon, Prof.

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 9, 2011

First Posted

April 13, 2012

Study Start

August 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

April 13, 2012

Record last verified: 2012-04

Locations