Effects of Dairy on Vitamin K-status

Vascular Health Clinical Trial

Official title:

The Effects of a Vitamin K-enriched Dairy Product on Vitamin K-status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01672099
• Other study ID #: 10-3-037
• Status: Completed
• Phase: N/A
• First received: July 9, 2012
• Last updated: August 21, 2012
• Start date: September 2010
• Est. completion date: April 2012

Study information

• Verified date: August 2012
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

In this study, the beneficial effect of a nutrient enriched dairy product will be investigated on vitamin K-status. To achive this benefit, the study product contains extra vitamin K2. In addition, extra dairy minerals have been added to the study product that may support general health.

Description:

In earlier studies, cardiovascular disease and osteoporosis were found to be associated with K2 intake, notably the higher menaquinones, MK-7, MK-8 and MK-9. Of these higher menaquinones, MK-7 was suggested to be the most effective form with respect to intestinal absorption, biologic half-life time, and efficacy on circulating biochemical markers. MK-7 is a natural product that is found in cheese, curd, and the Japanese food natto. Therefore, a nutrient enriched dairy product has been developed containing MK-7. The efficacy of this new product will be investigated on vitamin K status and on general health markers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• Apparently healthy men and postmenopausal women between 45 and 65 years old

• Subjects of body weight and height according to BMI between 23 and 30 kg/m2

• Subjects of Caucasian race

• Subject has given written consent to take part in the study

• Low vitamin K-status

Exclusion Criteria:

• Subjects with hypertension

• Subjects with hypercholesterolemia

• Subjects with (a history of) metabolic or gastrointestinal disease

• Subjects presenting chronic degenerative and/or inflammatory disease

• Subjects with (a history) of diabetes mellitus

• Abuse of drugs and/or alcohol

• Subjects receiving corticostero?d treatment

• Subjects using oral anticoagulants and subjects with clotting disorders

• Subjects using blood pressure lowering medication

• Subjects using cholesterol-lowering medication

• Subjects using multivitamins or vitamin K supplements

• Subjects consuming high amounts of vitamin K-containing food products

• Subjects with cow's milk allergy and lactose intolerance

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vascular Health
• Vitamin K-status

Intervention

Dietary Supplement:
• nutrient enriched product
The intervention in this study consists of the consumption of two nutrient enriched yoghurt products. The participants consume the study products twice a day during 12 weeks, one yoghurt product (250 ml) during breakfast and one yoghurt product (250 ml) during dinner.
• basic dairy product
The intervention in this study consists of the consumption of two basic yoghurt products. The participants consume the basic yoghurt products twice a day during 12 weeks, one yoghurt product (250 ml) during breakfast and one yoghurt product (250 ml) during dinner.

Locations

Country	Name	City	State
Netherlands	Vitak BV / Maastricht University Medical Center	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	markers of vascular health and inflammation	The secondary purpose of this study is to investigate the nutrient enriched product on markers of vascular and general health	12 weeks	No
Primary	undercarboxylated and carboxylated matrix-gla protein	The purpose of this study is to investigate the nutrient enriched product on vitamin K status as determined from the carboxylation status of Matrix Gla Protein	12 weeks	No
Secondary	undercarboxylated and carboxylated osteocalcin	The second purpose of this study is to investigate the nutrient enriched product on vitamin K status as determined from the carboxylation status of the vitamin K-dependent protein osteocalcin	12 weeks	No