OverweightPhase 2NCT02622425
The Effect of PD01 on Cardiovascular Health and Microbial Environment
A Phase 2 study testing PD01 in people with Overweight and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- PD01
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2015to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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%)
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Carotenoid-producing Bacillus Strain PD01 on Cardiovascular Health and Microbial Environment
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
- Being tested
- Placebo, PD01
- Keywords
- Carotenoid, Bacillus, Microbiota, Cardiovascular health
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
maltodextrin
PD01Dietary supplement
Carotenoid-producing Bacillus strain PD01
| Study group | Role | What they receive |
|---|---|---|
| PD01 | Active comparator | Carotenoid-producing Bacillus strain PD01 Receives: Dietary Supplement: PD01 |
| Placebo | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (16)
Effect on lipid peroxidation measured by blood concentration of F2-isoprostanes
Measured: 6 weeks
Effect on lipid peroxidation measured by blood total antioxidant capacity
Measured: 6 weeks
Effect on lipid peroxidation measured by blood MDA concentration
Measured: 6 weeks
Effect on low-grade inflammation measured by blood concentration of TNFalfa
Measured: 6 weeks
Effect on platelet aggregation measured by blood concentration of P-selectin
Measured: 6 weeks
Effect on blood glucose concentrations measured by blood glucose concentration
Measured: 6 weeks
Effect on blood lipid profile
Measured: 6 weeks
Effect on blood pressure
Measured: 6 weeks
Effect on body composition measured by BMI
Measured: 6 weeks
Effect on body composition measured by waist-hip circumference (WHC)
Measured: 6 weeks
The effect on fecal microbial community composition measured by fecal microbial community composition
Measured: 6 weeks
The effect on fecal microbial community composition measured by fecal short chain fatty acids (SCFA)
Measured: 6 weeks
Effect on gut barrier function measured by a sugar test
Measured: 6 weeks
To assess the bioavailability of PD01 by measuring blood carotenoid concentration
Measured: 6 weeks
Effect on digestive tolerance measured by GSRS questionnaire
Measured: 6 weeks
Effect on digestive tolerance measured by Bristol Stool Chart
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bouke Salden, Maastricht University Medical Center
- Investigators
- Ad Masclee, MD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622425
- Sponsor's protocol ID
- 153001
- Status last verified
- Dec 2016
- First submitted
- 30 Nov 2015
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Carotenoid-producing Bacillus Strain PD01 on Cardiovascular Health and Microbial Environment
- ClinicalTrials.gov ID
- NCT02622425
- Acronym / sponsor ID
- 153001
- Conditions
- Overweight, Obesity
- Keywords
- Carotenoid, Bacillus, Microbiota, Cardiovascular health
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD01 | Active comparator | Dietary Supplement: PD01Carotenoid-producing Bacillus strain PD01 |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%)
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebomaltodextrin | Dietary supplement | Placebo |
| PD01Carotenoid-producing Bacillus strain PD01 | Dietary supplement | PD01 |
Primary outcome
Effect on lipid peroxidation measured urinary F2-isoprostane excretion
Time frame: 6 weeks
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.
16 secondary outcomes
Effect on lipid peroxidation measured by blood concentration of F2-isoprostanes
Time frame: 6 weeks
Effect on lipid peroxidation measured by blood total antioxidant capacity
Time frame: 6 weeks
Effect on lipid peroxidation measured by blood MDA concentration
Time frame: 6 weeks
Effect on low-grade inflammation measured by blood concentration of TNFalfa
Time frame: 6 weeks
Effect on platelet aggregation measured by blood concentration of P-selectin
Time frame: 6 weeks
Effect on blood glucose concentrations measured by blood glucose concentration
Time frame: 6 weeks
Effect on blood lipid profile
Time frame: 6 weeks
Effect on blood pressure
Time frame: 6 weeks
Effect on body composition measured by BMI
Time frame: 6 weeks
Effect on body composition measured by waist-hip circumference (WHC)
Time frame: 6 weeks
The effect on fecal microbial community composition measured by fecal microbial community composition
Time frame: 6 weeks
The effect on fecal microbial community composition measured by fecal short chain fatty acids (SCFA)
Time frame: 6 weeks
Effect on gut barrier function measured by a sugar test
Time frame: 6 weeks
To assess the bioavailability of PD01 by measuring blood carotenoid concentration
Time frame: 6 weeks
Effect on digestive tolerance measured by GSRS questionnaire
Time frame: 6 weeks
Effect on digestive tolerance measured by Bristol Stool Chart
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ad Masclee, MD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PD01 in people with Overweight and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on lipid peroxidation measured urinary F2-isoprostane excretion (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2016.