SarcopeniaNCT02045355
Effects of Fish or Meat Consumption in Elderly
A study testing Fish intervention in people with Sarcopenia and Hip Fractures, run by University of Bergen at 2 sites in Norway.
Trial summary
Health effects of fish consumption have been demonstrated in epidemiological studies and in controlled intervention studies in a number of different population groups, however, randomized controlled studies on the effect of fish consumption in elderly are sparse. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia, Hip Fractures
- What is being tested?
- Fish intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesNorway
- Study dates
- Feb 2014to Jan 2017
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients >65 years with a first hip fracture who have a reasonable high chance of returning to their homes after rehabilitation,
- with a sufficient cognitive function to understand the objectives of the study
- the ability to go / walk without support of a person prior to the hip fracture.
- the life expectancy should be more than 6 months.
- the ability to use the provided food and willingness to participate
- sign the informed consent.
Who cannot join
- Patients are excluded who will probably not return to their home but to a nursing home.
- Patients who lack the cognitive function to understand the study objectives
- Patients with a missing informed consent
- Patients with reduced life expectancy of less than 6 months.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Haukeland University Hospital
Bergen, Hordaland, 5020
Haraldsplass Deacon Hospital
Bergen, Hordaland, 5892
About this study
Official title: Effects of Fish or Meat Consumption on Sarcopenia and Mobility in Elderly After Hip Fracture
Health effects of fish consumption have been demonstrated in epidemiological studies and in controlled intervention studies in a number of different population groups, however, randomized controlled studies on the effect of fish consumption in elderly are sparse. Many studies have focused on n-3 fatty acids instead of fish as a food and therefore, many health effects have only been related to the effect of n- 3 fatty acids. The elderly are a heterogeneous population group and therefore difficult to study. In order to reduce heterogeneity, it is advisable to focus on elderly with specific needs. Elderly who experienced a hip fracture can serve as a model for an advanced ageing process, as these patients typically experience a huge inflammatory response, immobilisation and a reduction in muscle mass. Increased fish intake is believed to have effects towards inflammation and a reduction in muscle mass. Therefore, we want to test whether increased fish intake can have positive health effects in elderly who experienced a hip fracture.
Main hypothesis:
Read more
Increased fish intake (salmon, cod, pelagic fish), in comparison to meat, will increase mobility, muscle strength and mobility in frail elderly.
Objectives
- To evaluate the health effects of fish consumption in frail elderly The effect of a dietary intervention with fish on mobility, muscle mass and strength in elderly who experienced a hip fracture has not been shown before.
- To demonstrate the feasibility of dietary intervention in elderly We want to show that a dietary intervention with fish or control meals is feasible in elderly. The meals (4 portions of fish per week or control portions of meat) will be delivered to their homes.
Description of work and role of participants This is a randomized clinical trial (RCT) on the effect of fish consumption on mobility in elderly who experienced a hip fracture. Elderly who experienced a hip fracture but were able to walk without support by a person before the fracture, will receive, after being randomized to two groups, fish or meat to be used in cold or warm meals at 4 days per week for a period of 16 weeks. Measurements will be taken at baseline (when patients have left the rehabilitation center), after 4 weeks and after 16 weeks. Measurements at 4 and 16 weeks after inclusion will be at their homes or in the outpatient clinic.
- Conditions
- Sarcopenia, Hip Fractures
- Being tested
- Fish intervention
- Medical subject headings
- Sarcopenia, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish interventionOther
The intervention will compare fish intake with a correspondent amount of meat. The basis for the comparison will be the estimated protein intake from fish and meat and should be almost similar both from fish and from meat. To ensure compliance and to add more variety to the diet, different fish types will be included in the intervention group and different meat sources in the control group. The types of fish (and that of meat in the control diet) that will be used will be accurately documented and will be similar for all participants included.
| Study group | Role | What they receive |
|---|---|---|
| Fish intervention | Experimental | The patients will receive one portion of salmon (150 g), one portion of cod (150 g), and two portions of sild (50g each) per week. Receives: Other: Fish intervention |
| Meat control group | No intervention | The control food will be pork and chicken (150 g each) and two portions of cooked ham / liver pate for use in cold meals (50 g each). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in New Mobility Score (NMS)
The NMS is an easy, reliable tool for the assessment of mobility. It is based on three questions, which are scored with 0 to 3, thus the result will be between 0 and 9 points.
Measured: Baseline and 16 weeks
Secondary outcomes (4)
Change of muscle mass
Measure muscle mass by using Bioelectrical impedance (BIA Anniversary 100)
Measured: Baseline and 16 weeks
Change in Vitamin D status
Measurement of serum 25OHD.
Measured: Baseline and 16 weeks
Change of muscle strength
Hand grip measurement (JAMAR).
Measured: Baseline and 16 weeks
Change of self-perceived health
Standardized questionnaire (EuroQol 5D)
Measured: Recruitment 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 posted24 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionJan 2016 (estimated)
- Study completionJan 2017 (estimated)
Why it stopped: Not enough patients to recruite.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Principal investigator, Jutta Dierkes, University of Bergen
- Investigators
- Jutta Dierkes, Principal investigator, Departmente of Clinical Medicine, University of BergenOddrun A Gudbrandsen, Principal investigator, Department of Clinical Medicine, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045355
- Sponsor's protocol ID
- 2013/2004-WP4
- Status last verified
- Dec 2015
- First submitted
- 17 Jan 2014
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Parker MJ, Palmer CR. A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg Br. 1993 Sep;75(5):797-8. doi: 10.1302/0301-620X.75B5.8376443.
PubMed 8376443
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fish or Meat Consumption on Sarcopenia and Mobility in Elderly After Hip Fracture
- ClinicalTrials.gov ID
- NCT02045355
- Acronym / sponsor ID
- 2013/2004-WP4
- Conditions
- Sarcopenia, Hip Fractures
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough patients to recruite.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- Feb 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 24 Jan 2014 (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.
Health effects of fish consumption have been demonstrated in epidemiological studies and in controlled intervention studies in a number of different population groups, however, randomized controlled studies on the effect of fish consumption in elderly are sparse. Many studies have focused on n-3 fatty acids instead of fish as a food and therefore, many health effects have only been related to the effect of n- 3 fatty acids. The elderly are a heterogeneous population group and therefore difficult to study. In order to reduce heterogeneity, it is advisable to focus on elderly with specific needs. Elderly who experienced a hip fracture can serve as a model for an advanced ageing process, as these patients typically experience a huge inflammatory response, immobilisation and a reduction in muscle mass. Increased fish intake is believed to have effects towards inflammation and a reduction in muscle mass. Therefore, we want to test whether increased fish intake can have positive health effects in elderly who experienced a hip fracture.
Main hypothesis:
Increased fish intake (salmon, cod, pelagic fish), in comparison to meat, will increase mobility, muscle strength and mobility in frail elderly.
Objectives
- To evaluate the health effects of fish consumption in frail elderly The effect of a dietary intervention with fish on mobility, muscle mass and strength in elderly who experienced a hip fracture has not been shown before.
- To demonstrate the feasibility of dietary intervention in elderly We want to show that a dietary intervention with fish or control meals is feasible in elderly. The meals (4 portions of fish per week or control portions of meat) will be delivered to their homes.
Description of work and role of participants This is a randomized clinical trial (RCT) on the effect of fish consumption on mobility in elderly who experienced a hip fracture. Elderly who experienced a hip fracture but were able to walk without support by a person before the fracture, will receive, after being randomized to two groups, fish or meat to be used in cold or warm meals at 4 days per week for a period of 16 weeks. Measurements will be taken at baseline (when patients have left the rehabilitation center), after 4 weeks and after 16 weeks. Measurements at 4 and 16 weeks after inclusion will be at their homes or in the outpatient clinic.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish intervention | Experimental | Other: Fish interventionThe patients will receive one portion of salmon (150 g), one portion of cod (150 g), and two portions of sild (50g each) per week. |
| Meat control group | No intervention | –The control food will be pork and chicken (150 g each) and two portions of cooked ham / liver pate for use in cold meals (50 g each). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Patients >65 years with a first hip fracture who have a reasonable high chance of returning to their homes after rehabilitation,
- with a sufficient cognitive function to understand the objectives of the study
- the ability to go / walk without support of a person prior to the hip fracture.
- the life expectancy should be more than 6 months.
- the ability to use the provided food and willingness to participate
Key exclusion criteria (4 listed)
- Patients are excluded who will probably not return to their home but to a nursing home.
- Patients who lack the cognitive function to understand the study objectives
- Patients with a missing informed consent
- Patients with reduced life expectancy of less than 6 months.
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 |
|---|---|---|
| Fish interventionThe intervention will compare fish intake with a correspondent amount of meat. The basis for the comparison will be the estimated protein intake from fish and meat and should be almost similar both from fish and from meat. To ensure compliance and to add more variety to the diet, different fish types will be included in the intervention group and different meat sources in the control group. The types of fish (and that of meat in the control diet) that will be used will be accurately documented and will be similar for all participants included. | Other | Fish intervention |
Primary outcome
Change in New Mobility Score (NMS)
Time frame: Baseline and 16 weeks
The NMS is an easy, reliable tool for the assessment of mobility. It is based on three questions, which are scored with 0 to 3, thus the result will be between 0 and 9 points.
4 secondary outcomes
Change of muscle mass
Time frame: Baseline and 16 weeks
Change in Vitamin D status
Time frame: Baseline and 16 weeks
Change of muscle strength
Time frame: Baseline and 16 weeks
Change of self-perceived health
Time frame: Recruitment and 4 months
Results and safety
The study was stopped early (reason given: Not enough patients to recruite.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
- Background: PubMed 8376443Parker MJ, Palmer CR. A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg Br. 1993 Sep;75(5):797-8. doi: 10.1302/0301-620X.75B5.8376443.
Related trials for Sarcopenia
Enrolling by invitation
Exercise Intervention for Breast Cancer Patients With Sarcopenia
Sarcopenia, Breast Cancer
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
RecruitingObservational study
Sarcopenia and Training Outcomes in Post-cardiac Surgery Patients
Sarcopenia, Cardiac Surgery
Not yet recruitingObservational study
CT Based Assessment of Sarcopenia and Its Association With Biologic Treatment Outcomes in Inflammatory Bowel Disease Patients
CT-Assessed Sarcopenia Outcomes
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.
Jutta Dierkes principal investigator
Departmente of Clinical Medicine, University of Bergen
Oddrun A Gudbrandsen principal investigator
Department of Clinical Medicine, University of Bergen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish intervention in people with Sarcopenia and Hip Fractures, run by University of Bergen at 2 sites in Norway.
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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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. 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 was stopped early (reason given: Not enough patients to recruite.). Results are not available in the source record.
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?
Change in New Mobility Score (NMS) (time frame: Baseline and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02045355, which also lists 1 linked publication.
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 14 Dec 2015.