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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD01 | Active Comparator | Carotenoid-producing Bacillus strain PD01 |
|
| Placebo | Placebo Comparator | Maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | maltodextrin |
| |
| PD01 |
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ad Masclee, MD | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MUMC+ | Maastricht | Limburg | 6229HX | Netherlands |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Dietary Supplement |
Carotenoid-producing Bacillus strain PD01 |
|
| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |