The Effect of PD01 on Cardiovascular Health and Microbial Environment

The Effect of the Carotenoid-producing Bacillus Strain PD01 on Cardiovascular Health and Microbial Environment

This randomized, placebo-controlled trial aims to determine the effects of daily administration of a carotenoid-producing Bacillus strain PD01 over a 6-week period on cardiovascular health biomarkers, microbiota composition and functioning and intestinal barrier function in overweight subjects.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: PD01

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229HX
      • MUMC+

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Overweight men/women (BMI 25-35 kg/m2)
• Healthy individuals
• Age between 18 and 70 years
• Fasting glucose < 7.0 mmol/L
• Normal HbA1c (4.4 to 6.2%)

Exclusion Criteria:

• Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L);
• History of (severe) cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol.
• Abdominal surgery interfering with gastrointestinal function, upon judgment of the principle investigator)
• Use of medication interfering with endpoints
• Use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine
• Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
• Use of antibiotics in the 90 days prior to the start of study
• Known pregnancy, lactation
• Abuse of products; alcohol (> 20 alcoholic consumptions per week) and drugs
• Smoking
• Blood donation within 3 months before study period
• Plans to lose weight or following a hypocaloric diet during the study period;
• Weight gain or loss > 3 kg in previous 3 months
• High physical activity (>4.5 hours of running/week)
• Hormone replacement therapy (women)
• History of any side effects towards intake of pro- or prebiotic supplements of any kind
• History of any side effects towards intake of carotenoids
• Prohibited use of pro-, pre- or synbiotics during study period and from one month prior to start of study.
• High intake of fruits and vegetables (more than the 75th percentile of dietary intake of fruits and vegetables)
• Vegetarians/vegans

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Maltodextrin	Dietary supplement: Placebo; maltodextrin
Active Comparator: PD01; Carotenoid-producing Bacillus strain PD01	Dietary supplement: PD01; Carotenoid-producing Bacillus strain PD01

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on lipid peroxidation measured urinary F2-isoprostane excretion	The primary objective of this study is to evaluate the efficacy of PD01 on lipid peroxidation by measuring F2-isoprostane excretion in 24-hour urine, after 6 weeks of administration.	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Effect on lipid peroxidation measured by blood concentration of F2-isoprostanes	6 weeks
Effect on lipid peroxidation measured by blood total antioxidant capacity	6 weeks
Effect on lipid peroxidation measured by blood MDA concentration	6 weeks
Effect on low-grade inflammation measured by blood concentration of TNFalfa	6 weeks
Effect on platelet aggregation measured by blood concentration of P-selectin	6 weeks
Effect on blood glucose concentrations measured by blood glucose concentration	6 weeks
Effect on blood lipid profile	6 weeks
Effect on blood pressure	6 weeks
Effect on body composition measured by BMI	6 weeks
Effect on body composition measured by waist-hip circumference (WHC)	6 weeks
The effect on fecal microbial community composition measured by fecal microbial community composition	6 weeks
The effect on fecal microbial community composition measured by fecal short chain fatty acids (SCFA)	6 weeks
Effect on gut barrier function measured by a sugar test	6 weeks
To assess the bioavailability of PD01 by measuring blood carotenoid concentration	6 weeks
Effect on digestive tolerance measured by GSRS questionnaire	6 weeks
Effect on digestive tolerance measured by Bristol Stool Chart	6 weeks

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Investigators: Principal Investigator: Ad Masclee, MD, Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: November 30, 2015
• First Submitted That Met QC Criteria: December 2, 2015
• First Posted (Estimate): December 4, 2015

Study Record Updates

• Last Update Posted (Estimate): December 12, 2016
• Last Update Submitted That Met QC Criteria: December 9, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Microbiota; Carotenoid; Cardiovascular health; Bacillus
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 153001