In this study, the beneficial effect of a nutrient enriched dairy product will be investigated on vascular health. To achive this benefit, the study product contains extra vitamin K2 (selected for its protective role in vascular calcification) and…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
preventie van hart-en vaatziekten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main parameters measured during the study are the undercarboxylated and
carboxylated forms of the vitamin K-dependent proteins matrix-gla protein and
osteocalcin.
Secondary outcome
The secondary study parameters are the levels of V-CAM, ICAM-1, E-selectin,
SAA, sPLA-2, CRP, vWF, VEGF, IL-6, TNF-α, total cholesterol, triglycerides, and
the lipoproteins HDL-cholesterol and LDL-cholesterol.
Background summary
Adequate nutritional intakes in the elderly supports general health and
vascular health in particularly. However, the intake of specific nutrients has
been regarded as suboptimal in older men and women, for instance intake of
vitamin K and omega-3 fatty acids. Cardiovascular disease is the leading cause
of morbidity and mortality in the western world. Healthy diet, including low
fat dairy products, helps to maintain cardiovascular health. Supplementation of
specific nutrients to a commercial standard dairy product may have extra
beneficial effects.
Study objective
In this study, the beneficial effect of a nutrient enriched dairy product will
be investigated on vascular health. To achive this benefit, the study product
contains extra vitamin K2 (selected for its protective role in vascular
calcification) and omega-3 fatty acids (selected for risk reduction in
atherosclerotic plaque formation) compared to basic dairy products. In
addition, extra minerals and antioxidants have been added to the dairy product
that may support general health.
Study design
A placebo-controlled randomized double-blind intervention study.
Intervention
The intervention in this study consists of daily consumption for 12 weeks of 2
basic yoghurt products (placebo group) or 2 nutrient-enriched yoghurt products
(treatment group).
Study burden and risks
The risks for the subjects are minimal. No adverse effects are to be expected
from the nutrient yoghurt enriched products. The subjects will visit the
BioPartner Center six times for the screening, information-visit and consequent
study visits and blood samplings at t=0, 4, 8 and 12 weeks. The major burden
for the subjects consists of 5 venipunctures in 12 weeks. The venipunctures
will be performed by experienced researchers.
Postbus 616
6200 MD
Nederland
Postbus 616
6200 MD
Nederland
Listed location countries
Age
Inclusion criteria
Apparently healthy men and postmenopausal women between 45 and 65 years old
Subjects of normal 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 vitamin K containing multivitamins or vitamin K supplements
Subjects consuming high amounts of vitamin K-containing food products
Subjects with cow*s milk allergy and lactose intolerance
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL32434.068.10 |