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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Recruitment Status : Withdrawn (Due to difficulties in recruiting frail subjects.)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

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.

Condition or disease Intervention/treatment Phase
Elderly Dietary Supplement: Whey protein high in leucin Dietary Supplement: Whey protein normal in leucin Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Leucine

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Protein balance [ Time Frame: Protein balance is measured in a triplet from 160-180 minutes into the protein supplementation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Locations
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Denmark
Department of endocrinology, Aarhus University hospital
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
The Danish Council for Strategic Research
Aarhus University Hospital
Investigators
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Principal Investigator: Jesper L Mehlsen, Phd student University of Aarhus

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02620111     History of Changes
Other Study ID Numbers: 44853
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: June 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No