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The Effect of PD01 on Cardiovascular Health and Microbial Environment

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Placebo
PD01
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Carotenoid, Bacillus, Microbiota, Cardiovascular health

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • MUMC+

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

PD01

Placebo

Arm Description

Carotenoid-producing Bacillus strain PD01

Maltodextrin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Effect on lipid peroxidation measured by blood concentration of F2-isoprostanes
Effect on lipid peroxidation measured by blood total antioxidant capacity
Effect on lipid peroxidation measured by blood MDA concentration
Effect on low-grade inflammation measured by blood concentration of TNFalfa
Effect on platelet aggregation measured by blood concentration of P-selectin
Effect on blood glucose concentrations measured by blood glucose concentration
Effect on blood lipid profile
Effect on blood pressure
Effect on body composition measured by BMI
Effect on body composition measured by waist-hip circumference (WHC)
The effect on fecal microbial community composition measured by fecal microbial community composition
The effect on fecal microbial community composition measured by fecal short chain fatty acids (SCFA)
Effect on gut barrier function measured by a sugar test
To assess the bioavailability of PD01 by measuring blood carotenoid concentration
Effect on digestive tolerance measured by GSRS questionnaire
Effect on digestive tolerance measured by Bristol Stool Chart

Full Information

First Posted
November 30, 2015
Last Updated
December 9, 2016
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02622425
Brief Title
The Effect of PD01 on Cardiovascular Health and Microbial Environment
Official Title
The Effect of the Carotenoid-producing Bacillus Strain PD01 on Cardiovascular Health and Microbial Environment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Carotenoid, Bacillus, Microbiota, Cardiovascular health

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PD01
Arm Type
Active Comparator
Arm Description
Carotenoid-producing Bacillus strain PD01
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
PD01
Intervention Description
Carotenoid-producing Bacillus strain PD01
Primary Outcome Measure Information:
Title
Effect on lipid peroxidation measured urinary F2-isoprostane excretion
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Effect on lipid peroxidation measured by blood concentration of F2-isoprostanes
Time Frame
6 weeks
Title
Effect on lipid peroxidation measured by blood total antioxidant capacity
Time Frame
6 weeks
Title
Effect on lipid peroxidation measured by blood MDA concentration
Time Frame
6 weeks
Title
Effect on low-grade inflammation measured by blood concentration of TNFalfa
Time Frame
6 weeks
Title
Effect on platelet aggregation measured by blood concentration of P-selectin
Time Frame
6 weeks
Title
Effect on blood glucose concentrations measured by blood glucose concentration
Time Frame
6 weeks
Title
Effect on blood lipid profile
Time Frame
6 weeks
Title
Effect on blood pressure
Time Frame
6 weeks
Title
Effect on body composition measured by BMI
Time Frame
6 weeks
Title
Effect on body composition measured by waist-hip circumference (WHC)
Time Frame
6 weeks
Title
The effect on fecal microbial community composition measured by fecal microbial community composition
Time Frame
6 weeks
Title
The effect on fecal microbial community composition measured by fecal short chain fatty acids (SCFA)
Time Frame
6 weeks
Title
Effect on gut barrier function measured by a sugar test
Time Frame
6 weeks
Title
To assess the bioavailability of PD01 by measuring blood carotenoid concentration
Time Frame
6 weeks
Title
Effect on digestive tolerance measured by GSRS questionnaire
Time Frame
6 weeks
Title
Effect on digestive tolerance measured by Bristol Stool Chart
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ad Masclee, MD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MUMC+
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229HX
Country
Netherlands

12. IPD Sharing Statement

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The Effect of PD01 on Cardiovascular Health and Microbial Environment

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