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Dietary Intake of Salmon and Bone Health

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02615301
Enrollment
122
Registered
2015-11-26
Start date
2009-01-31
Completion date
2009-06-30
Last updated
2015-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

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.

Interventions

DIETARY_SUPPLEMENTTailor-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_SUPPLEMENTTailor-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_SUPPLEMENTTailor-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_SUPPLEMENTSupplement 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.

Sponsors

Haukeland University Hospital
CollaboratorOTHER
National Institute of Nutrition and Seafood Research, Norway
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 64 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Deoxypyridinoline/creatinine3 monthsUrinary (mmol/l)
Bone-specific alkaline phosphatase3 monthsSerum (µg/l)
Osteocalcin3 monthsSerum (ng/ml)
Undercarboxylated osteocalcin (GLU)3 monthsSerum (ng/ml)
Carboxylated osteocalcine (GLA)3 monthsSerum (ng/ml)
GLU/GLA-ratio3 monthsRatio of undercarboxylated osteocalcin and carboxylated osteocalcine
N-telopeptides/creatinine3 monthsUrinary (mmol/l)

Secondary

MeasureTime frameDescription
Eicosapentaenoic acids3 monthsFatty acids composition of total red blood cells
Docosahexaenoic acids3 monthsFatty acids composition of total red blood cells
Omega-3 index3 monthsThe content of Eicosapentaenoic acids and Docosahexaenoic acids in red blood cell membranes expressed as percent of total fatty acids.
Body composition3 monthsTotal 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 density3 monthsThe total body bone mineral density (BMD) measurements were performed using dual-energy X-ray absorptiometry (DXA) on a stationary fan beam densitometer.
25-hyroxyvitamin D3 monthsSerum 25(OH)D (nmol/L)

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026