Impact of Carbohydrate Co-ingestion on the Post-prandial Anabolic Response of Protein in Young and Elderly Men
PRO-CARB
1 other identifier
interventional
48
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFirst Posted
Study publicly available on registry
April 13, 2012
CompletedApril 13, 2012
April 1, 2012
7 months
August 9, 2011
April 12, 2012
Conditions
Keywords
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)
EXPERIMENTALtest drink contains intrinsically labeled protein alone
GROUP 2 (OLD-PRO/CARB)
EXPERIMENTALtest drink contains intrinsically labeled protein and carbohydrate
GROUP 3 (YOUNG-PRO)
EXPERIMENTALtest drink contains intrinsically labeled protein alone
GROUP 4 (YOUNG-PRO/CARB)
EXPERIMENTALtest drink contains intrinsically labeled protein and carbohydrate
Interventions
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).
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).
Eligibility Criteria
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
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.
PMID: 32069356DERIVEDKouw 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.
PMID: 26037513DERIVEDGorissen 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.
PMID: 24628553DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luc JC van Loon, Prof.
Maastricht University
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