Obesity, Overweight
Conditions
Keywords
Carotenoid, Bacillus, Microbiota, Cardiovascular health
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
maltodextrin
DIETARY_SUPPLEMENTPD01
Carotenoid-producing Bacillus strain PD01
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect on lipid peroxidation measured urinary F2-isoprostane excretion | 6 weeks | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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 lipid peroxidation measured by blood concentration of F2-isoprostanes | 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 |
| Effect on body composition measured by BMI | 6 weeks |
Countries
Netherlands
Outcome results
None listed