The Effect of PD01 on Cardiovascular Health and Microbial Environment

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02622425
• Other study ID #: 153001
• Status: Completed
• Phase: Phase 2
• First received: November 30, 2015
• Last updated: December 9, 2016
• Start date: June 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2016
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Dietary Supplement:
• Placebo
maltodextrin
• PD01
Carotenoid-producing Bacillus strain PD01

Locations

Country	Name	City	State
Netherlands	MUMC+	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Effect on lipid peroxidation measured by blood concentration of F2-isoprostanes		6 weeks	No
Secondary	Effect on lipid peroxidation measured by blood total antioxidant capacity		6 weeks	No
Secondary	Effect on lipid peroxidation measured by blood MDA concentration		6 weeks	No
Secondary	Effect on low-grade inflammation measured by blood concentration of TNFalfa		6 weeks	No
Secondary	Effect on platelet aggregation measured by blood concentration of P-selectin		6 weeks	No
Secondary	Effect on blood glucose concentrations measured by blood glucose concentration		6 weeks	No
Secondary	Effect on blood lipid profile		6 weeks	No
Secondary	Effect on blood pressure		6 weeks	No
Secondary	Effect on body composition measured by BMI		6 weeks	No
Secondary	Effect on body composition measured by waist-hip circumference (WHC)		6 weeks	No
Secondary	The effect on fecal microbial community composition measured by fecal microbial community composition		6 weeks	No
Secondary	The effect on fecal microbial community composition measured by fecal short chain fatty acids (SCFA)		6 weeks	No
Secondary	Effect on gut barrier function measured by a sugar test		6 weeks	No
Secondary	To assess the bioavailability of PD01 by measuring blood carotenoid concentration		6 weeks	No
Secondary	Effect on digestive tolerance measured by GSRS questionnaire		6 weeks	No
Secondary	Effect on digestive tolerance measured by Bristol Stool Chart		6 weeks	No