NCT03378999

Rhodospirillum Rubrum and Cholesterol

A Proof of Concept Study to Demonstrate a Cholesterol-lowering Benefit of Oven-dried Rhodospirillum Rubrum

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Cholesterol Metabolism

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Rhodospirillum rubrum	Capsules containing oven-dried Rhodospirillum rubrum
DIETARY_SUPPLEMENT	Control	Capsules containing microcrystalline cellulose

Timeline

• Start date: 2018-06-14
• Primary completion: 2019-05-10
• Completion: 2019-05-10
• First posted: 2017-12-20
• Last updated: 2019-05-24

Locations

1 site across 1 country: Netherlands