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

NCT02620111 | Withdrawn

• 1 other identifier: 44853
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Elderly

Outcome Measures

Primary Outcomes (1)

• Protein balance

  Protein balance is measured in a triplet from 160-180 minutes into the protein supplementation

Study Arms (2)

Whey protein high leucine

EXPERIMENTAL

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

Whey protein normal leucine

ACTIVE COMPARATOR

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

Interventions

Whey protein high in leucin DIETARY_SUPPLEMENT

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 high leucine

Whey protein normal in leucin DIETARY_SUPPLEMENT

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.

Whey protein normal leucine

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Healthy elder people

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• The Danish Council for Strategic Research: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

Department of endocrinology, Aarhus University hospital

Aarhus C, 8000, Denmark

Location

Study Officials

• Jesper L Mehlsen, Phd student

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 2, 2015
• Study Start: June 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 25, 2016

Record last verified: 2015-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)