The Effect of PD01 on Cardiovascular Health and Microbial Environment

Study Overview
=================
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.

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

Conditions
-----------------
Overweight, Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Placebo
* Dietary Supplement: PD01


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PD01<br>Carotenoid-producing Bacillus strain PD01 | Dietary Supplement: PD01<br>* Carotenoid-producing Bacillus strain PD01<br>|
| Placebo Comparator: Placebo<br>Maltodextrin | Dietary Supplement: Placebo<br>* maltodextrin<br>|

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 | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carotenoid, Bacillus, Microbiota, Cardiovascular health