Dietary Intake of Salmon and Bone Health

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02615301
• Other study ID #: 252.07
• Status: Completed
• Phase: N/A
• First received: November 18, 2015
• Last updated: November 24, 2015
• Start date: January 2009
• Est. completion date: June 2009

Study information

• Verified date: November 2015
• Source: National Institute of Nutrition and Seafood Research, Norway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Norway	NIFES	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Nutrition and Seafood Research, Norway	Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone-specific alkaline phosphatase	Serum (µg/l)	3 months	No
Primary	Osteocalcin	Serum (ng/ml)	3 months	No
Primary	Undercarboxylated osteocalcin (GLU)	Serum (ng/ml)	3 months	No
Primary	Carboxylated osteocalcine (GLA)	Serum (ng/ml)	3 months	No
Primary	GLU/GLA-ratio	Ratio of undercarboxylated osteocalcin and carboxylated osteocalcine	3 months	No
Primary	N-telopeptides/creatinine	Urinary (mmol/l)	3 months	No
Primary	Deoxypyridinoline/creatinine	Urinary (mmol/l)	3 months	No
Secondary	25-hyroxyvitamin D	Serum 25(OH)D (nmol/L)	3 months	No
Secondary	Eicosapentaenoic acids	Fatty acids composition of total red blood cells	3 months	No
Secondary	Docosahexaenoic acids	Fatty acids composition of total red blood cells	3 months	No
Secondary	Omega-3 index	The content of Eicosapentaenoic acids and Docosahexaenoic acids in red blood cell membranes expressed as percent of total fatty acids.	3 months	No
Secondary	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.	3 months	No
Secondary	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.	3 months	No