Dietary Intake of Salmon and Bone Health

Overview

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).

Full Title of Study: “Intake of Dietary Vitamin D and K From Tailor-made Atlantic Salmon and Bone Health – A Randomized Intervention Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2009

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.

Interventions

  • Dietary Supplement: Tailor-made salmon with high levels of vitamin D3 and K1
    • 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.
  • Dietary Supplement: Tailor-made salmon with low levels of vitamin D3 and high K1
    • 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.
  • Dietary Supplement: Tailor-made salmon with high levels of vitamin D3 and low K1
    • 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.
  • Dietary Supplement: Supplement with vitamin D and Calcium
    • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 25-hyroxyvitamin D
    • Time Frame: 3 months
    • Serum 25(OH)D (nmol/L)
  • Eicosapentaenoic acids
    • Time Frame: 3 months
    • Fatty acids composition of total red blood cells
  • Docosahexaenoic acids
    • Time Frame: 3 months
    • Fatty acids composition of total red blood cells
  • Omega-3 index
    • Time Frame: 3 months
    • The content of Eicosapentaenoic acids and Docosahexaenoic acids in red blood cell membranes expressed as percent of total fatty acids.
  • Body composition
    • Time Frame: 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.
  • Bone mineral density
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 50 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • National Institute of Nutrition and Seafood Research, Norway
  • Collaborator
    • Haukeland University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jannike Øyen, Jannike Øyen, PhD – National Institute of Nutrition and Seafood Research, Norway
  • Overall Official(s)
    • Ingvild E Graff, PhD, Study Chair, NIFES, postboks 2029 Nordnes, 5815 Bergen, Norway

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