Overview

This trial is active, not recruiting.

Conditions overweight, obesity
Treatments placebo, pd01
Phase phase 2
Sponsor Maastricht University Medical Center
Start date June 2015
End date December 2015
Trial size 60 participants
Trial identifier NCT02622425, 153001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Carotenoid-producing Bacillus strain PD01
pd01
Carotenoid-producing Bacillus strain PD01
(Placebo Comparator)
Maltodextrin
placebo
maltodextrin

Primary Outcomes

Measure
Effect on lipid peroxidation measured urinary F2-isoprostane excretion
time frame: 6 weeks

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title The Effect of the Carotenoid-producing Bacillus Strain PD01 on Cardiovascular Health and Microbial Environment
Principal investigator Ad Masclee, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Maastricht University Medical Center.