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

Primary Purpose

Osteopenia

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Whey protein (HPHL)
Soy protein (HPLL)
Placebo (P)
Resistance training
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteopenia focused on measuring Osteopenia, Sarcopenia, Osteoporosis, Physical function, Body composition, Muscle protein, Leucine, Ketogenic amino acids, Resistance Training, Whey protein, Soy protein, Bone turnover

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of endocrinology, Aarhus University hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Whey protein (HPHL)

Soy protein (HPLL)

Placebo (P)

Arm Description

Whey protein supplementation and resistance training for four month.

Soy protein supplementation and resistance training for four month.

Maltodextrin supplementation and resistance training for four month.

Outcomes

Primary Outcome Measures

4 meter gait speed
We will measure changes in 4 meter gait speed.
Walk distance
We will measure changes in walk distance with the Six-Minute Walk Test.
Lean body mass(LBM)/Fat mass (FM) ratio.
We will measure changes in the ratio LBM/FM with a DEXA-scanner.

Secondary Outcome Measures

Full Information

First Posted
June 10, 2013
Last Updated
April 5, 2017
Sponsor
University of Aarhus
Collaborators
The Danish Council for Strategic Research
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1. Study Identification

Unique Protocol Identification Number
NCT01900548
Brief Title
Effect of Intake of Whey Protein in Elderly Osteopenic Patients. Implications for Metabolism and Physical Function.
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
The Danish Council for Strategic Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia
Keywords
Osteopenia, Sarcopenia, Osteoporosis, Physical function, Body composition, Muscle protein, Leucine, Ketogenic amino acids, Resistance Training, Whey protein, Soy protein, Bone turnover

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whey protein (HPHL)
Arm Type
Experimental
Arm Description
Whey protein supplementation and resistance training for four month.
Arm Title
Soy protein (HPLL)
Arm Type
Experimental
Arm Description
Soy protein supplementation and resistance training for four month.
Arm Title
Placebo (P)
Arm Type
Placebo Comparator
Arm Description
Maltodextrin supplementation and resistance training for four month.
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey protein (HPHL)
Intervention Description
The Whey protein group are supplemented 45 gram of whey protein, high protein high leucine (HPHL), every day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Soy protein (HPLL)
Intervention Description
The Soy protein group are supplemented 45 gram of Soy protein, high protein low leucine (HPLL), every day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo (P)
Intervention Description
Will not be given protein but the same energy content using maltodextrin (in a blended fashion).
Intervention Type
Other
Intervention Name(s)
Resistance training
Intervention Description
For 45 minutes 3 times a week the participants will complete resistance training with elastic bands in their own homes.
Primary Outcome Measure Information:
Title
4 meter gait speed
Description
We will measure changes in 4 meter gait speed.
Time Frame
Baseline and 4 months
Title
Walk distance
Description
We will measure changes in walk distance with the Six-Minute Walk Test.
Time Frame
Baseline and 4 months
Title
Lean body mass(LBM)/Fat mass (FM) ratio.
Description
We will measure changes in the ratio LBM/FM with a DEXA-scanner.
Time Frame
Baseline and 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bjørn Richelsen, Professor
Organizational Affiliation
The department of endocrinology, Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of endocrinology, Aarhus University hospital
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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

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