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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Recruitment Status : Withdrawn (Due to difficulties in recruiting frail subjects.)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
Sponsor:
Collaborators:
The Danish Council for Strategic Research
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date  ICMJE November 30, 2015
First Posted Date  ICMJE December 2, 2015
Last Update Posted Date October 25, 2016
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2015)
Protein balance [ Time Frame: Protein balance is measured in a triplet from 160-180 minutes into the protein supplementation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02620111 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Protein Balance in Protein Supplemented Elderly Patients: Acute Study With Protein-tracer-techniques
Official Title  ICMJE Effect of Protein High in Leucine on Muscle Protein Balance in Elderly Patients: Acute Study With Protein-tracer-techniques
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Elderly
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: 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.
    Intervention: Dietary Supplement: Whey protein normal in leucin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 24, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 1, 2015)
10
Estimated Study Completion Date  ICMJE September 2016
Estimated Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02620111
Other Study ID Numbers  ICMJE 44853
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE
  • The Danish Council for Strategic Research
  • Aarhus University Hospital
Investigators  ICMJE
Principal Investigator: Jesper L Mehlsen, Phd student University of Aarhus
PRS Account University of Aarhus
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP