Clinical trial NCT02622425: The Effect of PD01 on Cardiovascular Health and Microbial Environment
Official title: The Effect of the Carotenoid-producing Bacillus Strain PD01 on Cardiovascular Health and Microbial Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overweight
Obesity
Keywords: Carotenoid
Bacillus
Microbiota
Cardiovascular health
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2015-12-04
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Effect on lipid peroxidation measured urinary F2-isoprostane excretion
timeFrame: 6 weeks
Secondary outcomes:
measure: Effect on lipid peroxidation measured by blood concentration of F2-isoprostanes
timeFrame: 6 weeks
measure: Effect on lipid peroxidation measured by blood total antioxidant capacity
timeFrame: 6 weeks
measure: Effect on lipid peroxidation measured by blood MDA concentration
timeFrame: 6 weeks
measure: Effect on low-grade inflammation measured by blood concentration of TNFalfa
timeFrame: 6 weeks
measure: Effect on platelet aggregation measured by blood concentration of P-selectin
timeFrame: 6 weeks
measure: Effect on blood glucose concentrations measured by blood glucose concentration
timeFrame: 6 weeks
measure: Effect on blood lipid profile
timeFrame: 6 weeks
measure: Effect on blood pressure
timeFrame: 6 weeks
measure: Effect on body composition measured by BMI
timeFrame: 6 weeks
measure: Effect on body composition measured by waist-hip circumference (WHC)
timeFrame: 6 weeks
measure: The effect on fecal microbial community composition measured by fecal microbial community composition
timeFrame: 6 weeks
measure: The effect on fecal microbial community composition measured by fecal short chain fatty acids (SCFA)
timeFrame: 6 weeks
measure: Effect on gut barrier function measured by a sugar test
timeFrame: 6 weeks
measure: To assess the bioavailability of PD01 by measuring blood carotenoid concentration
timeFrame: 6 weeks
measure: Effect on digestive tolerance measured by GSRS questionnaire
timeFrame: 6 weeks
measure: Effect on digestive tolerance measured by Bristol Stool Chart
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: MUMC+
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Ad Masclee, MD
role: PRINCIPAL_INVESTIGATOR
References: