- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03378999
Rhodospirillum Rubrum and Cholesterol
A Proof of Concept Study to Demonstrate a Cholesterol-lowering Benefit of Oven-dried Rhodospirillum Rubrum
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objectives:
Secondary objectives are to investigate the effects on other CVD risk parameters: total cholesterol, triacylglycerol, HDL-C, glucose and blood pressure. Safety will be monitored by measurements of markers for liver, kidney and heart function.
Study design:
The study is a 4-weeks randomized, double-blind placebo-controlled trial with a parallel design using 3 doses oven-dried Rhodospirillum rubrum. Prior to and after the intervention period, a 2-week run-in and run-out period takes place, during which all subjects will consume placebo capsules.
Study population:
Eighty (N=80) healthy men with a slightly elevated fasting serum total cholesterol concentration (between 5.0-8.0 mmol/l) will complete the study.
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6229 ER
- Maastricht University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Minimum 80 kg body weight;
- Serum total cholesterol between 5.0 - 8.0 mmol/L (further testing is recommended for excessive hyperlipidemia [serum total cholesterol ≥ 8.0 mmol/L] according to the Standard for cardiovascular risk management of the Dutch general practitioners community [NHG]);
- Serum triacylglycerol concentrations < 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 alcoholic consumption 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;
- No active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident;
- 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 triacylglycerol 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 Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Control
Placebo capsules containing microcrystalline cellulose
|
Capsules containing microcrystalline cellulose
|
EXPERIMENTAL: Rhodospirillum rubrum 0.25 gram/day
Capsules containing oven-dried Rhodospirillum rubrum, 0.25 gram/day
|
Capsules containing oven-dried Rhodospirillum rubrum
|
EXPERIMENTAL: Rhodospirillum rubrum 0.5 gram/day
Capsules containing oven-dried Rhodospirillum rubrum, 0.5 gram/day
|
Capsules containing oven-dried Rhodospirillum rubrum
|
EXPERIMENTAL: Rhodospirillum rubrum 1.0 gram/day
Capsules containing oven-dried Rhodospirillum rubrum, 1.0 gram/day
|
Capsules containing oven-dried Rhodospirillum rubrum
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
LDL cholesterol concentrations
Time Frame: Change from baseline LDL cholesterol concentrations at 4 weeks
|
Fasting LDL cholesterol concentrations will be determined in blood samples using the Friedewald equation
|
Change from baseline LDL cholesterol concentrations at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Markers for fasting lipid metabolism
Time Frame: Change from baseline concentrations at 4 weeks
|
Markers for fasting lipid metabolism include serum total cholesterol (mmol/L), HDL cholesterol (mmol/L), and triacylglycerol concentrations (mmol/L).
|
Change from baseline concentrations at 4 weeks
|
Glucose concentrations
Time Frame: Change from baseline concentrations at 4 weeks
|
Fasting plasma glucose concentrations will determined in blood samples
|
Change from baseline concentrations at 4 weeks
|
Blood pressure
Time Frame: Change from baseline blood pressure at 4 weeks
|
Systolic and diastolic blood pressure
|
Change from baseline blood pressure at 4 weeks
|
C-reactive protein
Time Frame: hs-CRP will be will be measured at day 0, day 14, day 25 and day 28 of the intervention period
|
Concentrations of hs-CRP will be determined in blood samples
|
hs-CRP will be will be measured at day 0, day 14, day 25 and day 28 of the intervention period
|
Markers for liver function
Time Frame: These markers will be measured at day 0, day 14, day 25 and day 28 of the intervention period
|
Markers for liver function include ALAT, ASAT and yGT (U/L).
This panel of markers will be assessed to monitor liver function.
|
These markers will be measured at day 0, day 14, day 25 and day 28 of the intervention period
|
Markers for kidney function
Time Frame: These markers will be measured at day 0, day 14, day 25 and day 28 of the intervention period
|
Markers for kidney function include creatinine
|
These markers will be measured at day 0, day 14, day 25 and day 28 of the intervention period
|
Markers for heart function (NT-ProBNP)
Time Frame: These markers will be measured at day 0, day 14, day 25 and day 28 of the intervention period
|
Markers for heart function include NT-ProBNP.
This panel of markers will be assessed to monitor heart function.
|
These markers will be measured at day 0, day 14, day 25 and day 28 of the intervention period
|
Markers for heart function (vWF)
Time Frame: These markers will be measured at day 0, day 14, day 25 and day 28 of the intervention period
|
Markers for heart function include vWF.
This panel of markers will be assessed to monitor heart function.
|
These markers will be measured at day 0, day 14, day 25 and day 28 of the intervention period
|
Markers for heart function (Troponin-T)
Time Frame: These markers will be measured at day 0, day 14, day 25 and day 28 of the intervention period
|
Markers for heart function include Troponin-T.
This panel of markers will be assessed to monitor heart function.
|
These markers will be measured at day 0, day 14, day 25 and day 28 of the intervention period
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jogchum Plat, MSc, Maastricht University Medical Center
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- METC17-3-026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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