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

Effects of the gut flora on serum LDL cholesterol concentrations in slightly hypercholesterolemic subjects - Gut flora and lipid metabolism

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37583
Enrollment
90
Registered
2012-03-19
Start date
2012-04-15
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypercholesterolemia / increased serum cholesterol concentration

Interventions

During the experimental period, subjects will receive daily 6x250 Amoxicillinum Gb or placebo for 7 days. Placebo capsules will be filled with gelatine, cellulosum microcristallinum PH102. Blood sam

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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 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 (

Design outcomes

Secondary

MeasureTime frame
Secundary study parameters are changes in concentrations of HDL cholesterol, triacylglycerol and glucose. Changes in ex vivo and in vitro lipolysis in abdominal subcutaneous adipose and in skeletal tissue will be measured in a subgroup.

Primary

MeasureTime frame
The main study parameter is the change in fasting serum LDL-cholesterol concentrations.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)