Effects of Dairy on Vitamin K-status

NCT01672099 | Completed

• 1 other identifier: 10-3-037
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vitamin K-status; Vascular Health

Keywords

vitamin K2; menaquinone-7; vascular health

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• undercarboxylated and carboxylated osteocalcin

  12 weeks

Other Outcomes (1)

• markers of vascular health and inflammation

  12 weeks

Study Arms (2)

nutrient enriched dairy

ACTIVE COMPARATOR

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

Dietary Supplement: nutrient enriched product

Basic dairy

PLACEBO COMPARATOR

2 basic yoghurt products

Dietary Supplement: basic dairy product

Interventions

nutrient enriched product DIETARY_SUPPLEMENT

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.

nutrient enriched dairy

basic dairy product DIETARY_SUPPLEMENT

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.

Basic dairy

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Vitak BV / Maastricht University Medical Center

Maastricht, 6229 EV, Netherlands

Location

Study Officials

• Cees Vermeer, PhD

  VitaK BV Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2012
• First Posted: August 24, 2012
• Study Start: September 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: April 1, 2012
• Last Updated: August 24, 2012

Record last verified: 2012-08

Locations

NL (1)