Dietary Intake of Salmon and Bone Health

Not Applicable

Completed

• Conditions: Osteoporosis
• Interventions: 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 K1; Dietary Supplement: Supplement with vitamin D and Calcium; Dietary Supplement: Tailor-made salmon with high levels of vitamin D3 and low K1

• Registration Number: NCT02615301
• Lead Sponsor: National Institute of Nutrition and Seafood Research, Norway

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.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2015-11
• Study First Submitted: 2015-11-18
• Study First Submitted QC: 2015-11-24
• Last Update Submitted: 2015-11-24
• Study First Posted: 2015-11-26
• Last Update Posted: 2015-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Salmon (LD+HK)	Tailor-made salmon with low levels of vitamin D3 and high K1	Tailor-made salmon with low levels of vitamin D3 and high K1
Salmon (HD+HK)	Tailor-made salmon with high levels of vitamin D3 and K1	Tailor-made salmon with high levels of vitamin D3 and K1
Supplement (vitamin D + Calcium)	Supplement with vitamin D and Calcium	Supplement with vitamin D and Calcium
Salmon (HD+LK)	Tailor-made salmon with high levels of vitamin D3 and low K1	Tailor-made salmon with high levels of vitamin D3 and low K1

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

NIFES; 🇳🇴 Bergen, Norway