Effects of the gut flora on serum LDL cholesterol concentrations in slightly hypercholesterolemic subjects

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

- aged between 18-70 years
- mean serum total cholesterol concentrations between 5.0 - 8.0 mmol/L

Exclusion Criteria

- mean serum triacylglycerol > 3.0 mmol/L
- use of oral anticonceptives (OAC)
- pregnant or breastfeeding women
- subjects with kidney insufficiencies (defined as creatinine clearance <30 mL/min).
- unstable body weight (weight gain or loss >2 kg in the past 3 months)
- known allergy to antibiotics
- indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
- use of medication or a medically prescribed diet known to affect lipid or glucose metabolism
- active cardiovascular disease like congestive heart failure or recent (<6 months) event (acute myocardial infarction, cerebro vascular accident)
- severe medical conditions that might interfere with the study such as epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel diseases and rheumatoid arthritis
- abuse of drugs
- more than 21 alcohol consumptions per week for men and 14 consumptions for women
- not or difficult to venipuncture as evidenced during the screening visits
- use of an investigational product within the previous 30 days
- not willing to stop the consumption of products rich in plant stanol or sterol esters 3 weeks before the start of the study
- not willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study and during the study
- use of gastric acid inhibitors, laxantia, prebiotica, probiotica and antibiotica for at least one month before the start of the study and during the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the change in fasting serum LDL-cholesterol<br /><br>concentrations.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary study parameters are changes in concentrations of HDL cholesterol,<br /><br>triacylglycerol and glucose. Changes in ex vivo and in vitro lipolysis in<br /><br>abdominal subcutaneous adipose and in skeletal tissue will be measured in a<br /><br>subgroup.</p><br>