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

NCT ID: NCT01900548

Last Updated: 2017-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-01-31

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.

Conditions

Osteopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Whey protein (HPHL)

Whey protein supplementation and resistance training for four month.

Group Type: EXPERIMENTAL

Whey protein (HPHL)

Intervention Type: DIETARY_SUPPLEMENT

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

Resistance training

Intervention Type: OTHER

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

Soy protein (HPLL)

Soy protein supplementation and resistance training for four month.

Group Type: EXPERIMENTAL

Soy protein (HPLL)

Intervention Type: DIETARY_SUPPLEMENT

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

Resistance training

Intervention Type: OTHER

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

Placebo (P)

Maltodextrin supplementation and resistance training for four month.

Group Type: PLACEBO_COMPARATOR

Placebo (P)

Intervention Type: DIETARY_SUPPLEMENT

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

Resistance training

Intervention Type: OTHER

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

Interventions

Whey protein (HPHL)

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

Intervention Type: DIETARY_SUPPLEMENT

Soy protein (HPLL)

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo (P)

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

Intervention Type: DIETARY_SUPPLEMENT

Resistance training

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Danish Council for Strategic Research

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bjørn Richelsen, Professor

Role: PRINCIPAL_INVESTIGATOR

The department of endocrinology, Aarhus University Hospital

Locations

Department of endocrinology, Aarhus University hospital

Aarhus C, , Denmark

Countries

Denmark

Other Identifiers

1-10-72-136-13

Identifier Type: -

Identifier Source: org_study_id