The primary objective of the proposed study is to examine for the first time the LDL cholesterol lowering effect of oven-dried Rhodospirillum rubrum in humans. Secondary objectives are to investigate the effects on other CVD risk parameters: total…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
cholesterol metabolisme
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the change in serum LDL cholesterol concentrations.
Secondary outcome
Secondary study parameters are:
- Additional CVD risk markers like circulating concentrations of total
cholesterol, triacylglycerol, HDL cholesterol, glucose and hsCRP as well as
systolic and diastolic blood pressure
- Markers for liver (ALAT, ASAT yGT), kidney (creatinin) and heart function
(NT-ProBNP, vWF, c-Troponin T).
Background summary
Cardiovascular diseases are still the leading cause of morbidity and mortality
in the modern Western societies. Dietary interventions that aim to lower serum
LDL cholesterol concentrations are important, since a high LDL cholesterol is
causally related to cardiovascular risk. A reduction in serum LDL cholesterol
concentrations by 10% lowers future CVD risk by 20%.
Study objective
The primary objective of the proposed study is to examine for the first time
the LDL cholesterol lowering effect of oven-dried Rhodospirillum rubrum in
humans. Secondary objectives are to investigate the effects on other CVD risk
parameters: total cholesterol, triacylglycerol, HDL-C, glucose and blood
pressure. Finally, we will monitor safety parameters by weekly measurements of
a panel of endpoints consisting of markers for liver (ALAT, ASAT, *GT), and
kidney (creatinin) function as well as heart function (NT-ProBNP, vWF,
c-Troponin T).
Study design
The proposed study is a 4-weeks randomized, double-blind placebo-controlled
trial with a parallel design using 3 doses oven-dried Rhodospirillum rubrum.
Intervention
During the intervention period of 4 weeks, men will receive either placebo or
capsules containing 0.25 gr, 0.5 gr or 1.0 gr oven-dried Rhodospirillum rubrum
per day.
Study burden and risks
Men will be screened to determine eligibility during a visit of 15 minutes.
During this screening visit, anthropometric measurements will be performed and
blood pressure will be determined. In addition, a venous blood sample (5.0 mL)
will be drawn. During the study there will be 9 separate blood-sampling
moments. No direct health benefit for the study participants is expected,
besides the potential reduction in serum LDL cholesterol concentrations. Based
on animal experiments, investigational products are safe and suitable for human
consumption. Potential effects on heart function as seen by thousands fold
higher doses in animal studies will be monitored. In total during the entire
study 230 mL blood will be sampled (one screening of 5 mL, and nine times 25 mL
fasting blood, during the study). Some study subjects may report pain during
venipuncture. In addition, part of the study population will be asked to
complete a food frequency questionnaire twice. All measurements are routine in
our metabolic research unit (MRUM) and are not expected to lead to physical
side effects. Time investment for the participants is approximately 4 hours,
excluding travel time.
Universiteitsingel 50
Maastricht 6229 ER
NL
Universiteitsingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
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.
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 |
|---|---|
| Other | Na goedkeuring van de METC wordt het protocol in ClinicalTrials.gov geregistreerd |
| CCMO | NL62698.068.17 |