Effects of Fish or Meat Consumption in Elderly

Not Applicable

Terminated

• Conditions: Hip Fractures; Sarcopenia
• Interventions: Other: Fish intervention

• Registration Number: NCT02045355
• Lead Sponsor: University of Bergen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-17
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-24
• Study Start: 2014-02
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-11
• Last Update Posted: 2015-12-14
• Primary Completion: 2016-01
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fish intervention	Fish intervention	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.

Primary Outcome Measures

Name	Time	Method
Change in New Mobility Score (NMS)	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.

Secondary Outcome Measures

Name	Time	Method
Change of muscle mass	Baseline and 16 weeks	Measure muscle mass by using Bioelectrical impedance (BIA Anniversary 100)
Change of muscle strength	Baseline and 16 weeks	Hand grip measurement (JAMAR).
Change in Vitamin D status	Baseline and 16 weeks	Measurement of serum 25OHD.
Change of self-perceived health	Recruitment and 4 months	Standardized questionnaire (EuroQol 5D)

Trial Locations

Locations (2)

Haraldsplass Deacon Hospital; 🇳🇴 Bergen, Hordaland, Norway

Haukeland University Hospital; 🇳🇴 Bergen, Hordaland, Norway