Clinical trial NCT02045355: 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
Overall status: TERMINATED
Phase: NA
Conditions: Sarcopenia
Hip Fractures
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2014-01-24
Enrollment: 14
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

1. 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.
2. 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.


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.

Primary outcomes:
measure: Change in New Mobility Score (NMS)
timeFrame: Baseline and 16 weeks
Secondary outcomes:
measure: Change of muscle mass
timeFrame: Baseline and 16 weeks
measure: Change in Vitamin D status
timeFrame: Baseline and 16 weeks
measure: Change of muscle strength
timeFrame: Baseline and 16 weeks
measure: Change of self-perceived health
timeFrame: Recruitment and 4 months
Other outcomes:
measure: Change in inflammation
timeFrame: Baseline and 16 weeks
measure: Change of dietary habits
timeFrame: Baseline and 16 weeks
measure: Number of falls during intervention period
timeFrame: 16 weeks
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
state: Hordaland
city: Bergen
country: Norway
facility: Haraldsplass Deacon Hospital
state: Hordaland
Study officials:
affiliation: Departmente of Clinical Medicine, University of Bergen
name: Jutta Dierkes
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Clinical Medicine, University of Bergen
name: Oddrun A Gudbrandsen
role: PRINCIPAL_INVESTIGATOR
References:
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.