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Completed

NCT Number: NCT02615301

Dietary Intake of Salmon and Bone Health

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).

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Key information

Age range

50 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NIFES

Bergen, 5817, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tailor-made salmon with high levels of vitamin D3 and K1

Dietary Supplement

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.

Tailor-made salmon with low levels of vitamin D3 and high K1

Dietary Supplement

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.

Tailor-made salmon with high levels of vitamin D3 and low K1

Dietary Supplement

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.

Supplement with vitamin D and Calcium

Dietary Supplement

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.

Primary outcomes

  1. Bone-specific alkaline phosphatase

    Time frame: 3 months

    Serum (µg/l)

  2. Osteocalcin

    Time frame: 3 months

    Serum (ng/ml)

  3. Undercarboxylated osteocalcin (GLU)

    Time frame: 3 months

    Serum (ng/ml)

  4. Carboxylated osteocalcine (GLA)

    Time frame: 3 months

    Serum (ng/ml)

  5. GLU/GLA-ratio

    Time frame: 3 months

    Ratio of undercarboxylated osteocalcin and carboxylated osteocalcine

  6. N-telopeptides/creatinine

    Time frame: 3 months

    Urinary (mmol/l)

  7. Deoxypyridinoline/creatinine

    Time frame: 3 months

    Urinary (mmol/l)

Secondary outcomes

  1. 25-hyroxyvitamin D

    Time frame: 3 months

    Serum 25(OH)D (nmol/L)

  2. Eicosapentaenoic acids

    Time frame: 3 months

    Fatty acids composition of total red blood cells

  3. Docosahexaenoic acids

    Time frame: 3 months

    Fatty acids composition of total red blood cells

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

National Institute of Nutrition and Seafood Research, Norway

Other Gov

Collaborators

  • Haukeland University Hospital

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Nov 26, 2015
Registry last updated
Nov 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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