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| Name | Class |
|---|---|
| The Research Council of Norway | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of muscle mass | Measure muscle mass by using Bioelectrical impedance (BIA Anniversary 100) | Baseline and 16 weeks |
| Change in Vitamin D status | Measurement of serum 25OHD. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in inflammation | Measurement of C-reactive protein in blood samples | Baseline and 16 weeks |
| Change of dietary habits | Assessment of dietary habits using 24 hour recall. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jutta Dierkes | Departmente of Clinical Medicine, University of Bergen | Principal Investigator |
| Oddrun A Gudbrandsen | Department of Clinical Medicine, University of Bergen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Bergen | Hordaland | 5020 | Norway | ||
| Haraldsplass Deacon Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8376443 | Background | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 26, 2020 | |
| Reset | Mar 10, 2020 | |
| Release | Sep 21, 2020 | |
| Reset | Oct 13, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 26, 2020 | Mar 10, 2020 | |||
| Sep 21, 2020 |
| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
| Baseline and 16 weeks |
| Change of muscle strength | Hand grip measurement (JAMAR). | Baseline and 16 weeks |
| Change of self-perceived health | Standardized questionnaire (EuroQol 5D) | Recruitment and 4 months |
| Baseline and 16 weeks |
| Number of falls during intervention period | Weekly assessment of falls in the previous week by questionnaires | 16 weeks |
| Bergen |
| Hordaland |
| 5892 |
| Norway |
| Oct 13, 2020 |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |