Rhodospirillum Rubrum and Cholesterol

• ClinicalTrials.gov Identifier: NCT03378999
• Recruitment Status: Completed
• First Posted: December 20, 2017
• Last Update Posted: May 24, 2019
• Sponsor: Maastricht University Medical Center
• Collaborator: ezCOL B.V.
• Information provided by (Responsible Party): Maastricht University Medical Center

Study Description

Brief Summary:

The primary objective of the study is to examine for the first time the LDL cholesterol lowering effect of oven-dried Rhodospirillum rubrum in humans.

Condition or disease	Intervention/treatment	Phase
Cholesterol Metabolism	Dietary Supplement: Rhodospirillum rubrum; Dietary Supplement: Control	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: A Proof of Concept Study to Demonstrate a Cholesterol-lowering Benefit of Oven-dried Rhodospirillum Rubrum
• Actual Study Start Date: June 14, 2018
• Actual Primary Completion Date: May 10, 2019
• Actual Study Completion Date: May 10, 2019

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Control; Placebo capsules containing microcrystalline cellulose	Dietary Supplement: Control; Capsules containing microcrystalline cellulose
Experimental: Rhodospirillum rubrum 0.25 gram/day; Capsules containing oven-dried Rhodospirillum rubrum, 0.25 gram/day	Dietary Supplement: Rhodospirillum rubrum; Capsules containing oven-dried Rhodospirillum rubrum
Experimental: Rhodospirillum rubrum 0.5 gram/day; Capsules containing oven-dried Rhodospirillum rubrum, 0.5 gram/day	Dietary Supplement: Rhodospirillum rubrum; Capsules containing oven-dried Rhodospirillum rubrum
Experimental: Rhodospirillum rubrum 1.0 gram/day; Capsules containing oven-dried Rhodospirillum rubrum, 1.0 gram/day	Dietary Supplement: Rhodospirillum rubrum; Capsules containing oven-dried Rhodospirillum rubrum

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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).
2. Glucose concentrations [ Time Frame: Change from baseline concentrations at 4 weeks ]
   Fasting plasma glucose concentrations will determined in blood samples
3. Blood pressure [ Time Frame: Change from baseline blood pressure at 4 weeks ]
   Systolic and diastolic blood pressure
4. 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
5. 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.
6. 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
7. 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.
8. 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.
9. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Netherlands

Maastricht University Medical Center

Maastricht, Limburg, Netherlands, 6229 ER

Sponsors and Collaborators

Maastricht University Medical Center

ezCOL B.V.

Investigators

• Principal Investigator: Jogchum Plat, MSc; Maastricht University Medical Center

More Information

• Responsible Party: Maastricht University Medical Center
• ClinicalTrials.gov Identifier: NCT03378999
• Other Study ID Numbers: METC17-3-026
• First Posted: December 20, 2017
• Last Update Posted: May 24, 2019
• Last Verified: March 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No