Effects of Fish or Meat Consumption in Elderly

NCT02045355 | Terminated

• 1 other identifier: 2013/2004-WP4
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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. 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. 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.

Conditions

Sarcopenia; Hip Fractures

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 16 weeks

Secondary Outcomes (4)

• Change of muscle mass

  Baseline and 16 weeks

• Change in Vitamin D status

  Baseline and 16 weeks

• Change of muscle strength

  Baseline and 16 weeks

• Change of self-perceived health

  Recruitment and 4 months

Other Outcomes (3)

• Change in inflammation

  Baseline and 16 weeks

• Change of dietary habits

  Baseline and 16 weeks

• Number of falls during intervention period

  16 weeks

Study Arms (2)

Fish intervention

EXPERIMENTAL

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

Meat control group

NO INTERVENTION

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).

Interventions

Fish intervention 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.

Fish intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bergen: lead
• The Research Council of Norway: collaborator

Study Sites (2)

Haukeland University Hospital

Bergen, Hordaland, 5020, Norway

Location

Haraldsplass Deacon Hospital

Bergen, Hordaland, 5892, Norway

Location

Related Publications (1)

• 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.

  PMID: 8376443 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Hip Fractures

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Jutta Dierkes

  Departmente of Clinical Medicine, University of Bergen

  PRINCIPAL INVESTIGATOR

• Oddrun A Gudbrandsen

  Department of Clinical Medicine, University of Bergen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: January 24, 2014
• Study Start: February 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2017
• Last Updated: December 14, 2015

Record last verified: 2015-12

Locations

NO (2)