Protein Balance in Protein Supplemented Elderly Patients: Acute Study With Protein-tracer-techniques
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|ClinicalTrials.gov Identifier: NCT02620111|
Recruitment Status : Withdrawn (Due to difficulties in recruiting frail subjects.)
First Posted : December 2, 2015
Last Update Posted : October 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Elderly||Dietary Supplement: Whey protein high in leucin Dietary Supplement: Whey protein normal in leucin||Not Applicable|
Background: Improved muscle function/strength will enhance the quality of life of the more frail elderly population. Dietary proteins and amino acids act as anabolic substrates in muscles in elderly people. In particular the amino acid leucine is suggested to have an impact on muscle protein synthesis. In collaboration with the Danish dairy company Arla Foods we will use their conventional Whey protein and leucine enriched Whey protein in an acute study on elderly patients.
Our aim is to examine the acute effects of supplementation with whey protein high in leucine compared to whey protein with normal leucine content on muscle protein synthesis and protein balance in elderly patients.
Methods: We include 10 elderly patients, age 60-85 years in a randomized crossover study. The subjects will be recruited from the Osteoporosis Section at the Department of Endocrinology at Aarhus University Hospital. The subjects are their own controls in 2 x 1 day interventions A: whey protein high in leucine and B: whey protein with normal leucine content. Interventions are conducted with a 4 week washout period between them. On the intervention day postprandial protein synthesis rate will be measured over 2 X 3h using a tracer infusing protocol with 15Nphenylalanine along with blood samples and muscle biopsies. For analyzing steps of signaling in muscle protein synthesis initiated by leucine mammalian target of rapamycin (mTor) and sites downstream from mTor is quantified using western blotting. Whole body protein kinetics are calculated using the formula Q=i*Ei/Ep-i
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Effect of Protein High in Leucine on Muscle Protein Balance in Elderly Patients: Acute Study With Protein-tracer-techniques|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||September 2016|
Experimental: Whey protein high leucine
Subjects are supplemented water in a fasted state for 180 minutes while the isotopic tracer 15Nphenylalanin is infused. Subjects are supplemented with whey protein high in leucine from 180 - 360 minutes while the isotopic tracer 15Nphenylalanin is infused.
Dietary Supplement: Whey protein high in leucin
This Group is analysed for muscle protein synthesis and breakdown, mTor pathway signaling and Amino acid metabolism while supplemented first water then whey protein high in leucin
Active Comparator: Whey protein normal leucine
Subjects are supplemented water in a fasted state for 180 minutes while the isotopic tracer 15Nphenylalanin is infused. Subjects are supplemented with whey protein normal in leucine from 180 - 360 minutes while the isotopic tracer 15Nphenylalanin is infused.
Dietary Supplement: Whey protein normal in leucin
This Group is analysed for muscle protein synthesis and breakdown, mTor pathway signaling and Amino acid metabolism while supplemented first water then whey protein normal in leucin.
- Protein balance [ Time Frame: Protein balance is measured in a triplet from 160-180 minutes into the protein supplementation ]
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): NCT02620111
|Department of endocrinology, Aarhus University hospital|
|Aarhus C, Denmark, 8000|
|Principal Investigator:||Jesper L Mehlsen, Phd student||University of Aarhus|