Clinical trial NCT02620111: Protein Balance in Protein Supplemented Elderly Patients: Acute Study With Protein-tracer-techniques
Official title: Effect of Protein High in Leucine on Muscle Protein Balance in Elderly Patients: Acute Study With Protein-tracer-techniques
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Elderly
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Danish Council for Strategic Research
name: Aarhus University Hospital
First posted: 2015-12-02
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: Inclusion criteria:

- Healthy elder people

Exclusion criteria:

* Liver and kidney disease.
* Known diabetes or Hgb1c ≥6,5% (≥48mmol/l).
* Severe heart disease (NYHA-Class \>2).
* Oral corticosteroid treatment within the last 3 month.
* participation in other intervention studies within the last 4 weeks.

Primary outcomes:
measure: Protein balance
timeFrame: Protein balance is measured in a triplet from 160-180 minutes into the protein supplementation
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Department of endocrinology, Aarhus University hospital
Study officials:
affiliation: University of Aarhus
name: Jesper L Mehlsen, Phd student
role: PRINCIPAL_INVESTIGATOR
References: