Effects of Fish or Meat Consumption in Elderly
Primary Purpose
Sarcopenia, Hip Fractures
Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Fish intervention
Sponsored by
About this trial
This is an interventional prevention trial for Sarcopenia
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Haukeland University Hospital
- Haraldsplass Deacon Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Fish intervention
Meat control group
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change of muscle mass
Measure muscle mass by using Bioelectrical impedance (BIA Anniversary 100)
Change in Vitamin D status
Measurement of serum 25OHD.
Change of muscle strength
Hand grip measurement (JAMAR).
Change of self-perceived health
Standardized questionnaire (EuroQol 5D)
Full Information
NCT ID
NCT02045355
First Posted
January 17, 2014
Last Updated
December 11, 2015
Sponsor
University of Bergen
Collaborators
The Research Council of Norway
1. Study Identification
Unique Protocol Identification Number
NCT02045355
Brief Title
Effects of Fish or Meat Consumption in Elderly
Official Title
Effects of Fish or Meat Consumption on Sarcopenia and Mobility in Elderly After Hip Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
Not enough patients to recruite.
Study Start Date
February 2014 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bergen
Collaborators
The Research Council of Norway
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Hip Fractures
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fish intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Meat control group
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Fish intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in New Mobility Score (NMS)
Description
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.
Time Frame
Baseline and 16 weeks
Secondary Outcome Measure Information:
Title
Change of muscle mass
Description
Measure muscle mass by using Bioelectrical impedance (BIA Anniversary 100)
Time Frame
Baseline and 16 weeks
Title
Change in Vitamin D status
Description
Measurement of serum 25OHD.
Time Frame
Baseline and 16 weeks
Title
Change of muscle strength
Description
Hand grip measurement (JAMAR).
Time Frame
Baseline and 16 weeks
Title
Change of self-perceived health
Description
Standardized questionnaire (EuroQol 5D)
Time Frame
Recruitment and 4 months
Other Pre-specified Outcome Measures:
Title
Change in inflammation
Description
Measurement of C-reactive protein in blood samples
Time Frame
Baseline and 16 weeks
Title
Change of dietary habits
Description
Assessment of dietary habits using 24 hour recall.
Time Frame
Baseline and 16 weeks
Title
Number of falls during intervention period
Description
Weekly assessment of falls in the previous week by questionnaires
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jutta Dierkes
Organizational Affiliation
Departmente of Clinical Medicine, University of Bergen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Oddrun A Gudbrandsen
Organizational Affiliation
Department of Clinical Medicine, University of Bergen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
State/Province
Hordaland
ZIP/Postal Code
5020
Country
Norway
Facility Name
Haraldsplass Deacon Hospital
City
Bergen
State/Province
Hordaland
ZIP/Postal Code
5892
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
8376443
Citation
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.
Results Reference
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Effects of Fish or Meat Consumption in Elderly
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