Department of endocrinology, Aarhus University hospital
Aarhus C, 8000, Denmark
NCT Number: NCT01900548
The aim of this study is to investigate potential metabolic effects of whey protein high in protein and high in leucine(HPHL) compared to soy protein high in protein and low in leucine(HPLL) in osteopenic patients in a randomized controlled intervention study.
The investigator hypothesize that HPHL will increase physical function and the ratio muscle mass / fat mass in this condition.
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Notify Me60 year–85 year
All sexes
Interventional
Not applicable
Aarhus C, 8000, Denmark
With an increase in the older population in Denmark and most other countries there is an increase in the rate of patients with age related bone and muscle weakness. Proteins with a high content in ketogenic amino acids e.g. leucine have been investigated in relation to these conditions. Generally acute studies in animals and some in human have been conducted and have demonstrated positive effects in relation to prevention and treatment of bone and muscle weakness. We want to investigate these tendencies with supplementation of proteins in a randomized, blinded, 4 month intervention study with three arms - 1) the control group. 2) soy protein(high protein, low leucine). 3) Whey protein(high protein, high leucine). To increase any possible effect of the supplementation the subjects will complete a resistance training program concurrently. The study will focus on the anabolic properties of the ketogenic amino acids in animal whey protein compared to vegetable soy protein.
The investigator will study changes in:
The perspective in this study is to develop a nutritional supplement with a high content of ketogenic amino acids (e.g. Leucine) that can be useful and beneficial in treatment and prevention of patients with bone and muscle weakness.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Whey protein group are supplemented 45 gram of whey protein, high protein high leucine (HPHL), every day.
The Soy protein group are supplemented 45 gram of Soy protein, high protein low leucine (HPLL), every day.
Will not be given protein but the same energy content using maltodextrin (in a blended fashion).
For 45 minutes 3 times a week the participants will complete resistance training with elastic bands in their own homes.
Time frame: Baseline and 4 months
We will measure changes in 4 meter gait speed.
Time frame: Baseline and 4 months
We will measure changes in walk distance with the Six-Minute Walk Test.
Time frame: Baseline and 4 months
We will measure changes in the ratio LBM/FM with a DEXA-scanner.
University of Aarhus
Other
Effect of Intake of Protein High in Ketogenic Amino Acids (e.g. Leucine) in Elderly Osteopenic Patients. Implications for Muscle, Bone , Metabolism, and Physical Function.
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