The Effect of PD01 on Cardiovascular Health and Microbial Environment

NCT02622425 | Completed Phase 2 DMC

• 1 other identifier: 153001
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Keywords

Carotenoid; Bacillus; Microbiota; Cardiovascular health

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (16)

• Effect on lipid peroxidation measured by blood concentration of F2-isoprostanes

  6 weeks

• Effect on lipid peroxidation measured by blood total antioxidant capacity

  6 weeks

• Effect on lipid peroxidation measured by blood MDA concentration

  6 weeks

• Effect on low-grade inflammation measured by blood concentration of TNFalfa

  6 weeks

• Effect on platelet aggregation measured by blood concentration of P-selectin

  6 weeks

Study Arms (2)

PD01

ACTIVE COMPARATOR

Carotenoid-producing Bacillus strain PD01

Dietary Supplement: PD01

Placebo

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

maltodextrin

Placebo

PD01 DIETARY_SUPPLEMENT

Carotenoid-producing Bacillus strain PD01

PD01

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

MUMC+

Maastricht, Limburg, 6229HX, Netherlands

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ad Masclee, MD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 4, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 12, 2016

Record last verified: 2016-12

Locations

NL (1)