Effects of Fish or Meat Consumption in Elderly
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|ClinicalTrials.gov Identifier: NCT02045355|
Recruitment Status : Terminated (Not enough patients to recruite.)
First Posted : January 24, 2014
Last Update Posted : December 14, 2015
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.
Increased fish intake (salmon, cod, pelagic fish), in comparison to meat, will increase mobility, muscle strength and mobility in frail elderly.
- 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.
- 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 or disease||Intervention/treatment||Phase|
|Sarcopenia Hip Fractures||Other: Fish intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effects of Fish or Meat Consumption on Sarcopenia and Mobility in Elderly After Hip Fracture|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||January 2017|
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).
- Change in New Mobility Score (NMS) [ Time Frame: 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.
- Change of muscle mass [ Time Frame: Baseline and 16 weeks ]Measure muscle mass by using Bioelectrical impedance (BIA Anniversary 100)
- Change in Vitamin D status [ Time Frame: Baseline and 16 weeks ]Measurement of serum 25OHD.
- Change of muscle strength [ Time Frame: Baseline and 16 weeks ]Hand grip measurement (JAMAR).
- Change of self-perceived health [ Time Frame: Recruitment and 4 months ]Standardized questionnaire (EuroQol 5D)
- Change in inflammation [ Time Frame: Baseline and 16 weeks ]Measurement of C-reactive protein in blood samples
- Change of dietary habits [ Time Frame: Baseline and 16 weeks ]Assessment of dietary habits using 24 hour recall.
- Number of falls during intervention period [ Time Frame: 16 weeks ]Weekly assessment of falls in the previous week by questionnaires
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02045355
|Haukeland University Hospital|
|Bergen, Hordaland, Norway, 5020|
|Haraldsplass Deacon Hospital|
|Bergen, Hordaland, Norway, 5892|
|Principal Investigator:||Jutta Dierkes||Departmente of Clinical Medicine, University of Bergen|
|Principal Investigator:||Oddrun A Gudbrandsen||Department of Clinical Medicine, University of Bergen|