Effects of Fish or Meat Consumption in Elderly

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Bergen
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
Jutta Dierkes, University of Bergen
ClinicalTrials.gov Identifier:
NCT02045355
First received: January 17, 2014
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Sarcopenia
Hip Fractures
Other: Fish intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Fish or Meat Consumption on Sarcopenia and Mobility in Elderly After Hip Fracture

Resource links provided by NLM:


Further study details as provided by University of Bergen:

Primary Outcome Measures:
  • Change in New Mobility Score (NMS) [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
    Measure muscle mass by using Bioelectrical impedance (BIA Anniversary 100)

  • Change in Vitamin D status [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
    Measurement of serum 25OHD.

  • Change of muscle strength [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
    Hand grip measurement (JAMAR).

  • Change of self-perceived health [ Time Frame: Recruitment and 4 months ] [ Designated as safety issue: No ]
    Standardized questionnaire (EuroQol 5D)


Other Outcome Measures:
  • Change in inflammation [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
    Measurement of C-reactive protein in blood samples

  • Change of dietary habits [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
    Assessment of dietary habits using 24 hour recall.

  • Number of falls during intervention period [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Weekly assessment of falls in the previous week by questionnaires


Estimated Enrollment: 200
Study Start Date: February 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: 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.
No Intervention: 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).

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02045355

Locations
Norway
Haraldsplass Deacon Hospital Recruiting
Bergen, Hordaland, Norway, 5892
Contact: Anette H Ranhoff    0047 92810198    ahranhoff@yahoo.no   
Sub-Investigator: Hanne Gjessing         
Haukeland University Hospital Recruiting
Bergen, Hordaland, Norway, 5020
Contact: Gunnar Mellgren    0047 91132124    gunnar.mellgren@helse-bergen.no   
Sub-Investigator: Hanne R Gjessing         
Sponsors and Collaborators
University of Bergen
The Research Council of Norway
Investigators
Principal Investigator: Jutta Dierkes Departmente of Clinical Medicine, University of Bergen
Principal Investigator: Oddrun A Gudbrandsen Department of Clinical Medicine, University of Bergen
  More Information

Publications:
Responsible Party: Jutta Dierkes, Professor, University of Bergen
ClinicalTrials.gov Identifier: NCT02045355     History of Changes
Other Study ID Numbers: 2013/2004-WP4
Study First Received: January 17, 2014
Last Updated: July 10, 2014
Health Authority: Norway: Data Protection Authority
Norway: Directorate of Health
Norway: Ministry of Health and Care Services
Norway: Norwegian Social Science Data Services

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Sarcopenia
Atrophy
Femoral Fractures
Hip Injuries
Leg Injuries
Muscular Atrophy
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Pathological Conditions, Anatomical
Signs and Symptoms
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014