The Effect of PD01 on Cardiovascular Health and Microbial Environment

Maastricht University Medical Centre (MUMC)

Status and phase

Completed

Phase 2

Conditions

Overweight

Obesity

Treatments

Dietary Supplement: PD01

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02622425

153001

Details and patient eligibility

About

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.

Enrollment

62 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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