Elderly Clinical Trial - Protein Balance in Protein Supplemented Elderly

Status Withdrawn

Clinical Trial Summary

The aim of this study is to investigate potential protein synthesis effects of whey protein high in leucine compared to whey protein with normal leucin content in elderly patients in a acute crossover setting. We will use the method of a 2 X 3 h tracer infusing protocol with 15Nphenylalanine along with blood samples and muscle biopsies.

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Elderly

Clinical Trial Details

NCT number	NCT02620111
Study type	Interventional
Source	University of Aarhus
Contact
Status	Withdrawn
Phase	N/A
Start date	June 2015
Completion date	September 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Protein Balance in Protein Supplemented Elderly Patients: Acute Study With Protein-tracer-techniques

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms