In this study, the effects of low-fat dairy products on metabolic risk markers in subjects at increased risk of metabolic disorders are determined.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Endpoints are markers of insulin resistance, lipid profile, inflammation and
prothrombotic state.
Secondary outcome
-
Background summary
The metabolic syndrome is becoming a large problem in Western society. It is
important to timely recognize and treat the metabolic syndrome, to prevent its
health consequences such as cardiovascular disease and type 2 diabetes. No
straightforward approach exists to prevent or treat the metabolic syndrome.
However, a proper choice of foods may prevent or delay many of the health
consequences related to this syndrome and is therefore of relevance for a large
segment of the population.
There seems to be a negative correlation between dairy intake and type 2
diabetes, while the results of studies on cardiovascular effects are
conflicting. However, in most of these studies, no differentiation has been
made between whole and low-fat dairy products. Furthermore, due to the nature
of these studies, it cannot be concluded that increased consumption of dairy
products is causally related to (some of the components of) the metabolic
syndrome. Additionally, in studies on the effects of low-fat dairy products,
only the effects of single nutrients have been investigated. An intervention
study may therefore provide an answer to the question what the effects of
low-fat dairy are on the metabolism of subjects with the metabolic syndrome.
Study objective
In this study, the effects of low-fat dairy products on metabolic risk markers
in subjects at increased risk of metabolic disorders are determined.
Study design
The study will be carried out in a cross-over design. In the experimental
periods (8 weeks), subjects will consume 500 mL milk and 200 mL yogurt, or
control products. Between both periods will be a wash-out period of at least 2
weeks.
Intervention
500 mL low-fat milk and 200 mL low-fat yogurt daily. The control products are
600 mL fruit juice and 1 slice (20 g) of gingerbread or 1 (20 g) fruit biscuit.
Study burden and risks
Total time investment will be 350-390 min.
Venipunctures can occasionally cause a bruise or haematoma to occur.
Universiteitssingel 50
6229 ER Maastricht
Nederland
Universiteitssingel 50
6229 ER Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
Body mass index (BMI) > 30 kg/mw
or waist circumference > 88 cm (women) or > 102 cm (men)
Exclusion criteria
- BMI < 30 kg/m2 and waist circumference < 88 cm (women) or < 102 cm (men)
- cardiovascular disease
- triglycerides > 4.5 mmol/L
- familial hypercholesterolemia
- severe medical conditions, such as epilepsy, asthma, COPD, inflammatory bowel diseases and rheumatoid arthritis
- unstable body weight
- disturbed renal function
- liver diseases
- abnormal haematological profile
- drugs or alcohol abuse
- pregnancy and breast feeding
- use of an experimental product in the last 30 days
- participation in another study in the last 30 days
- blood donation in the last 30 days
- daily dairy consumption > 400 mL
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 | NL12906.068.06 |