Effect of Intake of Whey Protein in Elderly Osteopenic Patients. Implications for Metabolism and Physical Function.

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Osteopenia

Intervention / Treatment
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* Dietary Supplement: Whey protein (HPHL)
* Dietary Supplement: Soy protein (HPLL)
* Dietary Supplement: Placebo (P)
* Other: Resistance training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Osteopenia defined as BMD T-score <-1 Exclusion Criteria: Vitamin D deficiency defined as 25-hydroxyvitamin D (25-OH-D) below 30 nmol/l. 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. Anamnestic information of hip fracture or vertebral fracture. Any antiosteoporotic treatment. participation in other intervention studies within the last 4 weeks.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whey protein (HPHL)<br>Whey protein supplementation and resistance training for four month. | Dietary Supplement: Whey protein (HPHL)<br>* The Whey protein group are supplemented 45 gram of whey protein, high protein high leucine (HPHL), every day.<br>Other: Resistance training<br>* For 45 minutes 3 times a week the participants will complete resistance training with elastic bands in their own homes.<br>|
| Experimental: Soy protein (HPLL)<br>Soy protein supplementation and resistance training for four month. | Dietary Supplement: Soy protein (HPLL)<br>* The Soy protein group are supplemented 45 gram of Soy protein, high protein low leucine (HPLL), every day.<br>Other: Resistance training<br>* For 45 minutes 3 times a week the participants will complete resistance training with elastic bands in their own homes.<br>|
| Placebo Comparator: Placebo (P)<br>Maltodextrin supplementation and resistance training for four month. | Dietary Supplement: Placebo (P)<br>* Will not be given protein but the same energy content using maltodextrin (in a blended fashion).<br>Other: Resistance training<br>* For 45 minutes 3 times a week the participants will complete resistance training with elastic bands in their own homes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4 meter gait speed | We will measure changes in 4 meter gait speed. | Baseline and 4 months | 
| Walk distance | We will measure changes in walk distance with the Six-Minute Walk Test. | Baseline and 4 months | 
| Lean body mass(LBM)/Fat mass (FM) ratio. | We will measure changes in the ratio LBM/FM with a DEXA-scanner. | Baseline and 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteopenia, Sarcopenia, Osteoporosis, Physical function, Body composition, Muscle protein, Leucine, Ketogenic amino acids, Resistance Training, Whey protein, Soy protein, Bone turnover