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OpenTrials
Completed

NCT Number: NCT01900548

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whey protein (HPHL)

Dietary Supplement

The Whey protein group are supplemented 45 gram of whey protein, high protein high leucine (HPHL), every day.

Soy protein (HPLL)

Dietary Supplement

The Soy protein group are supplemented 45 gram of Soy protein, high protein low leucine (HPLL), every day.

Placebo (P)

Dietary Supplement

Will not be given protein but the same energy content using maltodextrin (in a blended fashion).

Resistance training

Other

For 45 minutes 3 times a week the participants will complete resistance training with elastic bands in their own homes.

Primary outcomes

  1. 4 meter gait speed

    Time frame: Baseline and 4 months

    We will measure changes in 4 meter gait speed.

  2. Walk distance

    Time frame: Baseline and 4 months

    We will measure changes in walk distance with the Six-Minute Walk Test.

  3. Lean body mass(LBM)/Fat mass (FM) ratio.

    Time frame: Baseline and 4 months

    We will measure changes in the ratio LBM/FM with a DEXA-scanner.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • The Danish Council for Strategic Research

Registry information

Official study title

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.

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jul 16, 2013
Registry last updated
Apr 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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