Clinical trial NCT02615301: Dietary Intake of Salmon and Bone Health
Official title: Intake of Dietary Vitamin D and K From Tailor-made Atlantic Salmon and Bone Health - A Randomized Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Lead sponsor: National Institute of Nutrition and Seafood Research, Norway
Sponsor class: OTHER_GOV
Collaborators: name: Haukeland University Hospital
First posted: 2015-11-26
Enrollment: 122
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Bone-specific alkaline phosphatase
timeFrame: 3 months
measure: Osteocalcin
timeFrame: 3 months
measure: Undercarboxylated osteocalcin (GLU)
timeFrame: 3 months
measure: Carboxylated osteocalcine (GLA)
timeFrame: 3 months
measure: GLU/GLA-ratio
timeFrame: 3 months
measure: N-telopeptides/creatinine
timeFrame: 3 months
measure: Deoxypyridinoline/creatinine
timeFrame: 3 months
Secondary outcomes:
measure: 25-hyroxyvitamin D
timeFrame: 3 months
measure: Eicosapentaenoic acids
timeFrame: 3 months
measure: Docosahexaenoic acids
timeFrame: 3 months
measure: Omega-3 index
timeFrame: 3 months
measure: Body composition
timeFrame: 3 months
measure: Bone mineral density
timeFrame: 3 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: NIFES
Study officials:
affiliation: NIFES, postboks 2029 Nordnes, 5815 Bergen, Norway
name: Ingvild E Graff, PhD
role: STUDY_CHAIR
References: