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Dietary Intake of Salmon and Bone Health

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ClinicalTrials.gov Identifier: NCT02615301
Recruitment Status : Completed
First Posted : November 26, 2015
Last Update Posted : November 26, 2015
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Jannike Øyen, 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).

Condition or disease Intervention/treatment Phase
Osteoporosis Dietary Supplement: Tailor-made salmon with high levels of vitamin D3 and K1 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 low K1 Dietary Supplement: Supplement with vitamin D and Calcium Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Intake of Dietary Vitamin D and K From Tailor-made Atlantic Salmon and Bone Health - A Randomized Intervention Study
Study Start Date : January 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Salmon (HD+HK)
Tailor-made salmon with high levels of vitamin D3 and K1
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.

Experimental: Salmon (LD+HK)
Tailor-made salmon with low levels of vitamin D3 and high K1
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.

Experimental: Salmon (HD+LK)
Tailor-made salmon with high levels of vitamin D3 and low K1
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.

Experimental: Supplement (vitamin D + Calcium)
Supplement with vitamin D and Calcium
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   50 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02615301


Locations
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Norway
NIFES
Bergen, Norway, 5817
Sponsors and Collaborators
National Institute of Nutrition and Seafood Research, Norway
Haukeland University Hospital
Investigators
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Study Chair: Ingvild E Graff, PhD NIFES, postboks 2029 Nordnes, 5815 Bergen, Norway
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Responsible Party: Jannike Øyen, Jannike Øyen, PhD, National Institute of Nutrition and Seafood Research, Norway
ClinicalTrials.gov Identifier: NCT02615301    
Other Study ID Numbers: 252.07
First Posted: November 26, 2015    Key Record Dates
Last Update Posted: November 26, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents