Skip to content

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

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01900548
Enrollment
57
Registered
2013-07-16
Start date
2014-01-31
Completion date
2016-01-31
Last updated
2017-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteopenia

Keywords

Osteopenia, Sarcopenia, Osteoporosis, Physical function, Body composition, Muscle protein, Leucine, Ketogenic amino acids, Resistance Training, Whey protein, Soy protein, Bone turnover

Brief 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.

Interventions

DIETARY_SUPPLEMENTWhey protein (HPHL)

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

DIETARY_SUPPLEMENTSoy protein (HPLL)

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

DIETARY_SUPPLEMENTPlacebo (P)

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

OTHERResistance training

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

Sponsors

The Danish Council for Strategic Research
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
4 meter gait speedBaseline and 4 monthsWe will measure changes in 4 meter gait speed.
Walk distanceBaseline and 4 monthsWe will measure changes in walk distance with the Six-Minute Walk Test.
Lean body mass(LBM)/Fat mass (FM) ratio.Baseline and 4 monthsWe will measure changes in the ratio LBM/FM with a DEXA-scanner.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026