Effects of Fish or Meat Consumption in Elderly

NCT ID: NCT02045355

Last Updated: 2015-12-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2017-01-31

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.

Conditions

Sarcopenia; Hip Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Fish intervention

Intervention Type: OTHER

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.

Meat control group

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fish intervention

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Research Council of Norway

OTHER

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: lead

Responsible Party

Jutta Dierkes

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jutta Dierkes

Role: PRINCIPAL_INVESTIGATOR

Departmente of Clinical Medicine, University of Bergen

Oddrun A Gudbrandsen

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Medicine, University of Bergen

Locations

Haukeland University Hospital

Bergen, Hordaland, Norway

Haraldsplass Deacon Hospital

Bergen, Hordaland, Norway

Countries

Norway

References

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.

Reference Type: BACKGROUND

PMID: 8376443 (View on PubMed)

Other Identifiers

2013/2004-WP4

Identifier Type: -

Identifier Source: org_study_id