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

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).

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5817
    • NIFES

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone-specific alkaline phosphatase	Serum (µg/l)	3 months
Osteocalcin	Serum (ng/ml)	3 months
Undercarboxylated osteocalcin (GLU)	Serum (ng/ml)	3 months
Carboxylated osteocalcine (GLA)	Serum (ng/ml)	3 months
GLU/GLA-ratio	Ratio of undercarboxylated osteocalcin and carboxylated osteocalcine	3 months
N-telopeptides/creatinine	Urinary (mmol/l)	3 months
Deoxypyridinoline/creatinine	Urinary (mmol/l)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
25-hyroxyvitamin D	Serum 25(OH)D (nmol/L)	3 months
Eicosapentaenoic acids	Fatty acids composition of total red blood cells	3 months
Docosahexaenoic acids	Fatty acids composition of total red blood cells	3 months
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
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
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

Collaborators and Investigators

• Sponsor: National Institute of Nutrition and Seafood Research, Norway
• Collaborators: Haukeland University Hospital
• Investigators: Study Chair: Ingvild E Graff, PhD, NIFES, postboks 2029 Nordnes, 5815 Bergen, Norway

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: November 18, 2015
• First Submitted That Met QC Criteria: November 24, 2015
• First Posted (Estimate): November 26, 2015

Study Record Updates

• Last Update Posted (Estimate): November 26, 2015
• Last Update Submitted That Met QC Criteria: November 24, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: 252.07