OsteopeniaNCT01900548
Effect of Intake of Whey Protein in Elderly Osteopenic Patients. Implications for Metabolism and Physical Function.
A study testing Whey protein (HPHL), Soy protein (HPLL) and Resistance training in people with Osteopenia, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Osteopenia
- What is being tested?
- Whey protein (HPHL), Soy protein (HPLL) and Resistance training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteopenia defined as BMD T-score <-1
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of endocrinology, Aarhus University hospital
Aarhus C, 8000
About this study
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.
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.
Read the 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
- Being tested
- Whey protein (HPHL), Soy protein (HPLL), Placebo (P), Resistance training
- Keywords
- Osteopenia, Sarcopenia, Osteoporosis, Physical function, Body composition, Muscle protein, Leucine, Ketogenic amino acids, Resistance Training, Whey protein, Soy protein, Bone turnover
- Medical subject headings
- Bone Diseases, Metabolic, Sarcopenia, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 trainingOther
For 45 minutes 3 times a week the participants will complete resistance training with elastic bands in their own homes.
| Study group | Role | What they receive |
|---|---|---|
| Whey protein (HPHL) | Experimental | Whey protein supplementation and resistance training for four month. Receives: Dietary Supplement: Whey protein (HPHL); Other: Resistance training |
| Soy protein (HPLL) | Experimental | Soy protein supplementation and resistance training for four month. Receives: Dietary Supplement: Soy protein (HPLL); Other: Resistance training |
| Placebo (P) | Placebo comparator | Maltodextrin supplementation and resistance training for four month. Receives: Dietary Supplement: Placebo (P); Other: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
4 meter gait speed
We will measure changes in 4 meter gait speed.
Measured: Baseline and 4 months
Walk distance
We will measure changes in walk distance with the Six-Minute Walk Test.
Measured: 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.
Measured: Baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Council for Strategic Research
- Responsible party
- Sponsor
- Investigators
- Bjørn Richelsen, Professor, Principal investigator, The department of endocrinology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900548
- Sponsor's protocol ID
- 1-10-72-136-13
- Status last verified
- Jul 2013
- First submitted
- 10 Jun 2013
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01900548
- Acronym / sponsor ID
- 1-10-72-136-13
- Conditions
- Osteopenia
- Keywords
- Osteopenia, Sarcopenia, Osteoporosis, Physical function, Body composition, Muscle protein, Leucine, Ketogenic amino acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Danish Council for Strategic Research
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 16 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whey protein (HPHL) | Experimental | Dietary Supplement: Whey protein (HPHL), Other: Resistance trainingWhey protein supplementation and resistance training for four month. |
| Soy protein (HPLL) | Experimental | Dietary Supplement: Soy protein (HPLL), Other: Resistance trainingSoy protein supplementation and resistance training for four month. |
| Placebo (P) | Placebo comparator | Dietary Supplement: Placebo (P), Other: Resistance trainingMaltodextrin supplementation and resistance training for four month. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Osteopenia defined as BMD T-score <-1
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey protein (HPHL)The Whey protein group are supplemented 45 gram of whey protein, high protein high leucine (HPHL), every day. | Dietary supplement | Whey protein (HPHL) |
| Soy protein (HPLL)The Soy protein group are supplemented 45 gram of Soy protein, high protein low leucine (HPLL), every day. | Dietary supplement | Soy protein (HPLL) |
| Placebo (P)Will not be given protein but the same energy content using maltodextrin (in a blended fashion). | Dietary supplement | Placebo (P) |
| Resistance trainingFor 45 minutes 3 times a week the participants will complete resistance training with elastic bands in their own homes. | Other | Placebo (P), Soy protein (HPLL), Whey protein (HPHL) |
Primary outcome
4 meter gait speed
Time frame: Baseline and 4 months
We will measure changes in 4 meter gait speed.
Walk distance
Time frame: Baseline and 4 months
We will measure changes in walk distance with the Six-Minute Walk Test.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bjørn Richelsen, Professor principal investigator
The department of endocrinology, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein (HPHL), Soy protein (HPLL) and Resistance training in people with Osteopenia, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4 meter gait speed (time frame: Baseline and 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.