Effect of Intake of Whey Protein in Elderly Osteopenic Patients. Implications for Metabolism and Physical Function.
Condition: Osteopenia
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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:

        -  Gait speed related to muscle strength

        -  Walk distance in a Six-minute walk test related to sub maximal physical capacity

        -  Body composition (LBM/FM ratio) by a DEXA-scanner

        -  Biochemical markers on bone metabolism

        -  Bone-mineral-density(BMD) and -content(BMC)(DEXA scans)

        -  Muscle strength

        -  Body balance

        -  Protein and amino acid balance

        -  Nitrogen balance

        -  Gene-expression in muscle tissue

        -  Biochemical markers on fat- sugar- and protein-metabolism

        -  Biochemical markers on inflammation

        -  Blood pressure

        -  Insulin sensitivity by HOMA index

        -  Estimated maximal physical capacity by a bicycle ergometer test.

      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.
    

Intervention name(s): Whey protein (HPHL); Soy protein (HPLL); Placebo (P); Resistance training
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Osteopenia; Sarcopenia; Osteoporosis; Physical function; Body composition; Muscle protein; Leucine; Ketogenic amino acids; Resistance Training; Whey protein; Soy protein; Bone turnover