Dietary Intake of Salmon and Bone Health

Study Overview
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Brief Summary
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The aims of this study were to investigate how intake of tailor-made salmon affected bone biomarkers, nutritional status, as well as body composition and bone mineral density. The 122 healthy postmenopausal women included in this 12 weeks intervention study were randomized into four groups: three salmon groups (with three different vitamin D3/vitamin K1 combinations) and one tablet group (vitamin D and Calcium).

Detailed Description
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Suboptimal vitamin D status is common among humans, and might have a negative impact on bone health. Fatty fish, including Atlantic salmon, is an important dietary vitamin D source. However, due to a considerable change in fish feed composition, the contribution of vitamin D from salmon fillet has been reduced. The aims were to investigate how intake of tailor-made salmon affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density (BMD). The 122 healthy postmenopausal women (median 55 years) included in this 12 weeks intervention study were randomized into four groups: three salmon groups (150 grams/two times/week) and one tablet group (800IU vitamin D and 1000 mg Calcium/day). The salmon groups also received calcium supplements (1000 mg/d). The salmon had three different vitamin D3/vitamin K1 combinations: high D3 + high K1, low D3 + high K1, or high D3 + low K1.

Official Title
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Intake of Dietary Vitamin D and K From Tailor-made Atlantic Salmon and Bone Health - A Randomized Intervention Study

Conditions
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Osteoporosis

Intervention / Treatment
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* Dietary Supplement: Tailor-made salmon with high levels of vitamin D3 and K1
* Dietary Supplement: Tailor-made salmon with low levels of vitamin D3 and high K1
* Dietary Supplement: Tailor-made salmon with high levels of vitamin D3 and low K1
* Dietary Supplement: Supplement with vitamin D and Calcium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal women Caucasian ethnicity Age range 50-65 years Having postmenopausal age of at least one year Exclusion Criteria: Osteoporotic fractures Medical treatment for osteoporosis Warfarin treatment Creatinine above or below normal range Hypervitaminosis D Malabsorption syndrome Inflammatory bowel disease Inflammatory rheumatic diseases Women who had planned to go away on holiday during the intervention could not participate

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salmon (HD+HK)<br>Tailor-made salmon with high levels of vitamin D3 and K1 | Dietary Supplement: Tailor-made salmon with high levels of vitamin D3 and K1<br>* The aims were to investigate how intake of tailor-made salmon with high levels of vitamin D3 and K1 affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density.<br>|
| Experimental: Salmon (LD+HK)<br>Tailor-made salmon with low levels of vitamin D3 and high K1 | Dietary Supplement: Tailor-made salmon with low levels of vitamin D3 and high K1<br>* The aims were to investigate how intake of tailor-made salmon with low levels of vitamin D3 and high K1 affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density.<br>|
| Experimental: Salmon (HD+LK)<br>Tailor-made salmon with high levels of vitamin D3 and low K1 | Dietary Supplement: Tailor-made salmon with high levels of vitamin D3 and low K1<br>* The aims were to investigate how intake of tailor-made salmon with high levels of vitamin D3 and low K1 affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density.<br>|
| Experimental: Supplement (vitamin D + Calcium)<br>Supplement with vitamin D and Calcium | Dietary Supplement: Supplement with vitamin D and Calcium<br>* The aims were to investigate how supplement with vitamin D and Calcium affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone-specific alkaline phosphatase | Serum (µg/l) | 3 months | 
| Osteocalcin | Serum (ng/ml) | 3 months | 
| Undercarboxylated osteocalcin (GLU) | Serum (ng/ml) | 3 months | 
| Carboxylated osteocalcine (GLA) | Serum (ng/ml) | 3 months | 
| GLU/GLA-ratio | Ratio of undercarboxylated osteocalcin and carboxylated osteocalcine | 3 months | 
| N-telopeptides/creatinine | Urinary (mmol/l) | 3 months | 
| Deoxypyridinoline/creatinine | Urinary (mmol/l) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 25-hyroxyvitamin D | Serum 25(OH)D (nmol/L) | 3 months | 
| Eicosapentaenoic acids | Fatty acids composition of total red blood cells | 3 months | 
| Docosahexaenoic acids | Fatty acids composition of total red blood cells | 3 months | 
| Omega-3 index | The content of Eicosapentaenoic acids and Docosahexaenoic acids in red blood cell membranes expressed as percent of total fatty acids. | 3 months | 
| Body composition | Total body soft tissue composition (fat mass and lean mass) measurements were performed using dual-energy X-ray absorptiometry (DXA) on a stationary fan beam densitometer. | 3 months | 
| Bone mineral density | The total body bone mineral density (BMD) measurements were performed using dual-energy X-ray absorptiometry (DXA) on a stationary fan beam densitometer. | 3 months |