Effects of Dairy on Vitamin K-status

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Vitamin K-status; Vascular Health

Treatments: Dietary Supplement: nutrient enriched product; Dietary Supplement: basic dairy product

Study type: Interventional

Funder types: Other

Identifiers

NCT01672099

10-3-037

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 corticosteroϊd 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 2 patient groups, including a placebo group

nutrient enriched dairy

Active Comparator group

Description:

Yoghurt product which contains vitamin K2 and extra dairy nutrients; all in a concentration of 15% of the recommended allowed daily intake (RDI)

Treatment:

Dietary Supplement: nutrient enriched product

Basic dairy

Placebo Comparator group

Description:

2 basic yoghurt products

Treatment:

Dietary Supplement: basic dairy product