The Effect of PD01 on Cardiovascular Health and Microbial Environment

Phase 2

Completed

• Conditions: Overweight; Obesity
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: PD01

• Registration Number: NCT02622425
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-11-30
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted QC: 2015-12-02
• Study First Posted: 2015-12-04
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-09
• Last Update Posted: 2016-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Maltodextrin
PD01	PD01	Carotenoid-producing Bacillus strain PD01

Primary Outcome Measures

Name	Time	Method
Effect on lipid peroxidation measured urinary F2-isoprostane excretion	6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

MUMC+; 🇳🇱 Maastricht, Limburg, Netherlands