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.

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.

Study Overview

• Status: Completed
• Conditions: Osteopenia
• Intervention / Treatment: Dietary supplement: Whey protein (HPHL); Other: Resistance training; Dietary supplement: Soy protein (HPLL); Dietary supplement: Placebo (P)

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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus C, Denmark, 8000
    • Department of Endocrinology, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: The Danish Council for Strategic Research
• Investigators: Principal Investigator: Bjørn Richelsen, Professor, The department of endocrinology, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: June 10, 2013
• First Submitted That Met QC Criteria: July 11, 2013
• First Posted (Estimate): July 16, 2013

Study Record Updates

• Last Update Posted (Actual): April 7, 2017
• Last Update Submitted That Met QC Criteria: April 5, 2017
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Body composition; Sarcopenia; Osteoporosis; Resistance Training; Soy protein; Whey protein; Physical function; Osteopenia; Leucine; Bone turnover; Muscle protein; Ketogenic amino acids
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic
• Other Study ID Numbers: 1-10-72-136-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No