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

Elderly Clinical Trial

Official title:

Effect of Protein High in Leucine on Muscle Protein Balance in Elderly Patients: Acute Study With Protein-tracer-techniques

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02620111
• Other study ID #: 44853
• Status: Withdrawn
• Phase: N/A
• First received: November 30, 2015
• Last updated: October 24, 2016
• Start date: June 2015
• Est. completion date: September 2016

Study information

• Verified date: June 2015
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Elderly

Intervention

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
• 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.

Locations

Country	Name	City	State
Denmark	Department of endocrinology, Aarhus University hospital	Aarhus C

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, The Danish Council for Strategic Research

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protein balance		Protein balance is measured in a triplet from 160-180 minutes into the protein supplementation	Yes