Dietary Intake of Salmon and Bone Health
Primary Purpose
Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Tailor-made salmon with high levels of vitamin D3 and K1
Tailor-made salmon with low levels of vitamin D3 and high K1
Tailor-made salmon with high levels of vitamin D3 and low K1
Supplement with vitamin D and Calcium
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis
Eligibility 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
Sites / Locations
- NIFES
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Salmon (HD+HK)
Salmon (LD+HK)
Salmon (HD+LK)
Supplement (vitamin D + Calcium)
Arm Description
Tailor-made salmon with high levels of vitamin D3 and K1
Tailor-made salmon with low levels of vitamin D3 and high K1
Tailor-made salmon with high levels of vitamin D3 and low K1
Supplement with vitamin D and Calcium
Outcomes
Primary Outcome Measures
Bone-specific alkaline phosphatase
Serum (µg/l)
Osteocalcin
Serum (ng/ml)
Undercarboxylated osteocalcin (GLU)
Serum (ng/ml)
Carboxylated osteocalcine (GLA)
Serum (ng/ml)
GLU/GLA-ratio
Ratio of undercarboxylated osteocalcin and carboxylated osteocalcine
N-telopeptides/creatinine
Urinary (mmol/l)
Deoxypyridinoline/creatinine
Urinary (mmol/l)
Secondary Outcome Measures
25-hyroxyvitamin D
Serum 25(OH)D (nmol/L)
Eicosapentaenoic acids
Fatty acids composition of total red blood cells
Docosahexaenoic acids
Fatty acids composition of total red blood cells
Omega-3 index
The content of Eicosapentaenoic acids and Docosahexaenoic acids in red blood cell membranes expressed as percent of total fatty acids.
Body composition
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
The total body bone mineral density (BMD) measurements were performed using dual-energy X-ray absorptiometry (DXA) on a stationary fan beam densitometer.
Full Information
NCT ID
NCT02615301
First Posted
November 18, 2015
Last Updated
November 24, 2015
Sponsor
National Institute of Nutrition and Seafood Research, Norway
Collaborators
Haukeland University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02615301
Brief Title
Dietary Intake of Salmon and Bone Health
Official Title
Intake of Dietary Vitamin D and K From Tailor-made Atlantic Salmon and Bone Health - A Randomized Intervention Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Nutrition and Seafood Research, Norway
Collaborators
Haukeland University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Salmon (HD+HK)
Arm Type
Experimental
Arm Description
Tailor-made salmon with high levels of vitamin D3 and K1
Arm Title
Salmon (LD+HK)
Arm Type
Experimental
Arm Description
Tailor-made salmon with low levels of vitamin D3 and high K1
Arm Title
Salmon (HD+LK)
Arm Type
Experimental
Arm Description
Tailor-made salmon with high levels of vitamin D3 and low K1
Arm Title
Supplement (vitamin D + Calcium)
Arm Type
Experimental
Arm Description
Supplement with vitamin D and Calcium
Intervention Type
Dietary Supplement
Intervention Name(s)
Tailor-made salmon with high levels of vitamin D3 and K1
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Tailor-made salmon with low levels of vitamin D3 and high K1
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Tailor-made salmon with high levels of vitamin D3 and low K1
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Supplement with vitamin D and Calcium
Intervention Description
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 Measure Information:
Title
Bone-specific alkaline phosphatase
Description
Serum (µg/l)
Time Frame
3 months
Title
Osteocalcin
Description
Serum (ng/ml)
Time Frame
3 months
Title
Undercarboxylated osteocalcin (GLU)
Description
Serum (ng/ml)
Time Frame
3 months
Title
Carboxylated osteocalcine (GLA)
Description
Serum (ng/ml)
Time Frame
3 months
Title
GLU/GLA-ratio
Description
Ratio of undercarboxylated osteocalcin and carboxylated osteocalcine
Time Frame
3 months
Title
N-telopeptides/creatinine
Description
Urinary (mmol/l)
Time Frame
3 months
Title
Deoxypyridinoline/creatinine
Description
Urinary (mmol/l)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
25-hyroxyvitamin D
Description
Serum 25(OH)D (nmol/L)
Time Frame
3 months
Title
Eicosapentaenoic acids
Description
Fatty acids composition of total red blood cells
Time Frame
3 months
Title
Docosahexaenoic acids
Description
Fatty acids composition of total red blood cells
Time Frame
3 months
Title
Omega-3 index
Description
The content of Eicosapentaenoic acids and Docosahexaenoic acids in red blood cell membranes expressed as percent of total fatty acids.
Time Frame
3 months
Title
Body composition
Description
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.
Time Frame
3 months
Title
Bone mineral density
Description
The total body bone mineral density (BMD) measurements were performed using dual-energy X-ray absorptiometry (DXA) on a stationary fan beam densitometer.
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingvild E Graff, PhD
Organizational Affiliation
NIFES, postboks 2029 Nordnes, 5815 Bergen, Norway
Official's Role
Study Chair
Facility Information:
Facility Name
NIFES
City
Bergen
ZIP/Postal Code
5817
Country
Norway
12. IPD Sharing Statement
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Dietary Intake of Salmon and Bone Health
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