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Dietary Intake of Salmon and Bone Health

NCT ID: NCT02615301

Last Updated: 2015-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-06-30

Brief Summary

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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

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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.

Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Salmon (HD+HK)

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Salmon (LD+HK)

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Salmon (HD+LK)

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

Group Type EXPERIMENTAL

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

Intervention Type 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 (vitamin D + Calcium)

Supplement with vitamin D and Calcium

Group Type EXPERIMENTAL

Supplement with vitamin D and Calcium

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role collaborator

National Institute of Nutrition and Seafood Research, Norway

OTHER_GOV

Sponsor Role lead

Responsible Party

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Jannike Øyen

Jannike Øyen, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ingvild E Graff, PhD

Role: STUDY_CHAIR

NIFES, postboks 2029 Nordnes, 5815 Bergen, Norway

Locations

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NIFES

Bergen, , Norway

Site Status

Countries

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Norway

Other Identifiers

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252.07

Identifier Type: -

Identifier Source: org_study_id