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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
62
MUMC+
Maastricht, Limburg, Netherlands
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.
Time frame: 6 weeks
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)
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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