The effect of the carotenoid-producing Bacillus strain PD01 on cardiovascular health and microbial environment

Completed

• Conditions: Risicofactoren voor cardiovasculaire ziekten; systemische laaggradige inflammatie; verstoringen intestinale barrierefunctie; obesity; overweight

• Registration Number: NL-OMON42293
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-12-08
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 99

Inclusion Criteria

Phase 1: healthy individuals (men/women), BMI 18.5-35 kg/m2, age 18-65
Phase 2: Men/women, BMI 25-35 kg/m2, healthy human beings, age between 18 and 71 years, fasting glucose <7.0 mmol/L, Hba1c between 4.4-6.2%

Exclusion Criteria

Phase 1:
• 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
• Abnormal lab test results
• Use of medication
• 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
• Pregnancy, lactation
• Abuse of products; alcohol (> 20 alcoholic consumptions per week) and drugs
• Smoking
• Blood donation within 3 months before study period
• Weight gain or loss > 3 kg in previous 3 months
• High physical activity (>4.5 hours of running/week)
• 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. A list with forbidden products will be provided (see E4 Lijst_verbodenvoeding_v1)
• Vegetarians/vegans;Phase 2:
• 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. A list with forbidden products will be provided (see E4 Lijst_verbod

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Phase 1: The primary objective is safety, measured by blood parameters and<br /><br>questionnaires.<br /><br>Phase 2: The primary efficacy parameter of the study is lipid peroxidation, as<br /><br>assessed by urinary concentration of F2-isoprostanes. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Phase 2:<br /><br>Secondary endpoints entail the evaluation of effects of daily administration of<br /><br>PD01 on lipid peroxidation (blood measurements), low-grade inflammation (blood<br /><br>and fecal measurements), platelet aggregation (blood measurements), glucose /<br /><br>insulin metabolism (blood measurements), lipid profile (blood measurements),<br /><br>blood pressure & heart rate, body composition, microbiota composition and<br /><br>functioning (fecal measurements), gut barrier function (blood and fecal<br /><br>measurements, urine collection), bioavailability (blood measurements) and<br /><br>tolerance and digestive (dys)comfort.</p><br>