A proof of concept study to demonstrate a cholesterol-lowering benefit of oven-dried Rhodospirillum rubrum

Completed

• Conditions: cholesterol metabolisme; cholesterol metabolism; risk factors for cardiovascular diseases

• Registration Number: NL-OMON48754
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

- Aged between 18-75 years;
- Men;
- Minimum 80 kg body weight;
- Serum total cholesterol between 5.0 - 8.0 mmol/L;
- Serum triglycerides concentrations below 4.5 mmol/L;
- No signs of liver and/or kidney dysfunction;
- No diabetic patients;
- No familial hypercholesterolemia;
- No abuse of drugs;
- Not more than 4 alcohol consumptions per day with a maximum of 21 per week;
- Stable body weight (weight gain or loss < 3 kg in the past three months);
- No use of medication known to treat blood pressure, lipid or glucose metabolism;
- No use of an investigational product within another biomedical intervention trial within the previous 1-month;
- No severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis;
- Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study;
- No difficult venipuncture as evidenced during the screening visit;
- Willing to comply to study protocol during study;
- Informed consent signed.

Exclusion Criteria

- Serum total cholesterol < 5.0 mmol/L or * 8.0 mmol/L;
- Serum triglyceride concentrations * 4.5 mmol/L;
- Signs of liver and/or kidney dysfunction;
- Diabetic patients;
- Familial hypercholesterolemia;
- Abuse of drugs;
- More than 4 alcoholic consumptions per day or 21 per week;
- Unstable body weight (weight gain or loss > 3 kg in the past three months);
- Use medication known to treat blood pressure, lipid or glucose metabolism;
- Use of an investigational product within another biomedical intervention trial within the previous 1-month;
- Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis;
- Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident;
- Not willing to give up being a blood donor from 8 weeks before the start of the study, during the study or for 4 weeks after completion of the study;
- Not or difficult to venipuncture as evidenced during the screening visit;
- Use of over-the-counter and prescribed medication or supplements, which may interfere with study measurements to be judged by the principal investigator;
- Use of oral antibiotics in 40 days or less prior to the start of the study;
- Blood donation in the past 3 months before the start of the study;
- Not willing to comply to study protocol during study or sign informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the change in serum LDL cholesterol concentrations.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are:<br /><br>- Additional CVD risk markers like circulating concentrations of total<br /><br>cholesterol, triacylglycerol, HDL cholesterol, glucose and hsCRP as well as<br /><br>systolic and diastolic blood pressure<br /><br>- Markers for liver (ALAT, ASAT yGT), kidney (creatinin) and heart function<br /><br>(NT-ProBNP, vWF, c-Troponin T). </p><br>