Rhodospirillum Rubrum and Cholesterol

NCT03378999 | Completed DMC

• 1 other identifier: METC17-3-026
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholesterol Metabolism

Outcome Measures

Primary Outcomes (1)

• LDL cholesterol concentrations

  Fasting LDL cholesterol concentrations will be determined in blood samples using the Friedewald equation

  Change from baseline LDL cholesterol concentrations at 4 weeks

Secondary Outcomes (9)

• Markers for fasting lipid metabolism

  Change from baseline concentrations at 4 weeks

• Glucose concentrations

  Change from baseline concentrations at 4 weeks

• Blood pressure

  Change from baseline blood pressure at 4 weeks

• C-reactive protein

  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

  These markers will be measured at day 0, day 14, day 25 and day 28 of the intervention period

Study Arms (4)

Control

PLACEBO COMPARATOR

Placebo capsules containing microcrystalline cellulose

Dietary Supplement: Control

Rhodospirillum rubrum 0.25 gram/day

EXPERIMENTAL

Capsules containing oven-dried Rhodospirillum rubrum, 0.25 gram/day

Dietary Supplement: Rhodospirillum rubrum

Rhodospirillum rubrum 0.5 gram/day

EXPERIMENTAL

Capsules containing oven-dried Rhodospirillum rubrum, 0.5 gram/day

Dietary Supplement: Rhodospirillum rubrum

Rhodospirillum rubrum 1.0 gram/day

EXPERIMENTAL

Capsules containing oven-dried Rhodospirillum rubrum, 1.0 gram/day

Dietary Supplement: Rhodospirillum rubrum

Interventions

Rhodospirillum rubrum DIETARY_SUPPLEMENT

Capsules containing oven-dried Rhodospirillum rubrum

Rhodospirillum rubrum 0.25 gram/day; Rhodospirillum rubrum 0.5 gram/day; Rhodospirillum rubrum 1.0 gram/day

Control DIETARY_SUPPLEMENT

Capsules containing microcrystalline cellulose

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• ezCOL B.V.: collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 ER, Netherlands

Location

Study Officials

• Jogchum Plat, MSc

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 20, 2017
• Study Start: June 14, 2018
• Primary Completion: May 10, 2019
• Study Completion: May 10, 2019
• Last Updated: May 24, 2019

Record last verified: 2019-03

Locations

NL (1)