The Effect of PD01 on Cardiovascular Health and Microbial Environment

NCT ID: NCT02622425

Last Updated: 2016-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2015-12-31

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.

Conditions

Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

PD01

Carotenoid-producing Bacillus strain PD01

Group Type: ACTIVE_COMPARATOR

PD01

Intervention Type: DIETARY_SUPPLEMENT

Carotenoid-producing Bacillus strain PD01

Placebo

Maltodextrin

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

maltodextrin

Interventions

Placebo

maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

PD01

Carotenoid-producing Bacillus strain PD01

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Bouke Salden

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ad Masclee, MD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

MUMC+

Maastricht, Limburg, Netherlands

Countries

Netherlands

Other Identifiers

153001

Identifier Type: -

Identifier Source: org_study_id