- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04364074
Acute Probiotic Supplementation and Endothelial Function
Acute Impact of Probiotic Supplementation on Endothelial Function in Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Researchers at MCW have discovered a new pathway that links the type of bacteria present in the intestines to the severity of heart attacks. This discovery of a relationship between intestinal bacteria, bacterial metabolites, and severity of heart attacks means that for the first time, we may be able to determine a person's probability of having a heart attack via non-conventional risk factors. This may provide opportunities for novel diagnostic tests as well as a potential for therapeutic intervention. The link between gut microbiota and the severity of heart attacks may also lead to novel therapeutic approaches (probiotics, non-absorbable antibiotics) to prevent heart attacks from happening. Our pilot study has demonstrated that supplementation of Lactobacillus plantarum 299v (Lp299v) for 6 weeks to adults with a history of coronary artery disease showed improvement in endothelial function. Whether acute ingestion of a single drink containing Lp299v supplementation favorably impacts vascular endothelial function is not known. The study proposed will test the hypothesis that supplementation of Lp299v favorably impacts vascular endothelial function after ingestion of a single supplement containing Lp299v.
Specific Aim 1 will determine the acute impact of probiotic supplementation on endothelial cell function as measured by brachial artery flow mediated dilation (FMD)
Specific Aim 2 will determine the impact of acute probiotic supplementation on blood biomarkers for inflammation.
Specific Aim 3 will be to determine the impact of baseline constitution of intestinal microbiota (assessed by stool microbiome) on change in FMD as a result of acute response to probiotic supplementation.
Specific Aim 4 will be to determine the impact of baseline constitution of intestinal microbiota (assessed by stool microbiome) on change in levels of blood markers for inflammation as a result of acute response probiotic supplementation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Wisconsin
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Wauwatosa, Wisconsin, United States, 53222
- Medical College of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Have at least one of the following conditions:
- Hypertension
- Hyperlipidemia
- Diabetes mellitus (Type 1 or Type 2)
- Peripheral vascular disease
- Cerebrovascular disease
- Cardiovascular disease.
Exclusion Criteria:
- Unstable angina or myocardial infarction by history, ECG, and/or enzymatic criteria within 1 month of enrollment.
- LV dysfunction as defined by an LV ejection fraction documented as < 45% within 1 year of enrollment by an echocardiogram, MRI, or nuclear imaging.
Uncontrolled hypertension with blood pressure greater than 170/100 mmHg at the screening visit.
- Known history of chronic renal insufficiency, liver dysfunction, or cancer besides non-melanoma skin carcinomas or localized prostate cancer requiring systemic treatment within five years of enrollment.
- Known history of cognitive impairment or inability to follow study procedures
- Patient with an implanted defibrillator or permanent pacemaker on which the potential participant is known to rely upon for greater than 50% of ventricular depolarizations.
- Patients who received probiotics, prebiotics, and antibiotics in the last 12 weeks.
- Patients with dosing changes of vasoactive medications and HMG-CoA reductase inhibitors in the 6 weeks prior to enrollment.
- Pregnancy
- Patients who are currently taking Vitamin K antagonists such as coumadin, warfarin.
- Those who are daily drinkers.
- Patients with gastrointestinal diseases that might alter the impact of a probiotic (e.g. status post colectomy, short gut syndrome, or inflammatory bowel disease)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GoodBelly Probiotic
Subjects randomized to this arm consume one serving of the Goodbelly lactobacillus plantarum 299v probiotic
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Consumption of 1 serving of Goodbelly probiotic daily for 6 weeks.
This will be followed by an observation period for 6 weeks during which the subjects will not consume Goodbelly.
Other Names:
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Placebo Comparator: Placebo
Subjects randomized to this arm consume one serving of the Goodbelly that does not contain lactobacillus plantarum 299v
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To prepare the placebo, the dietitian will first heat a water bath to 80 degrees Celsius.
This removes the lactobacillus plantarum 299v from the probiotic drink
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in baseline flow mediated dilation (FMD) after probiotic consumption
Time Frame: from baseline to 24 hours after consumption and approximately 7 days after consumption
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This is a measurement of endothelial function in the brachial artery
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from baseline to 24 hours after consumption and approximately 7 days after consumption
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interleukin-6
Time Frame: from baseline to 24 hours after consumption and approximately 7 days after consumption
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Circulating marker of inflammation
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from baseline to 24 hours after consumption and approximately 7 days after consumption
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Interleukin-8
Time Frame: from baseline to 24 hours after consumption and approximately 7 days after consumption
|
Circulating marker of inflammation
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from baseline to 24 hours after consumption and approximately 7 days after consumption
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Interleukin-12
Time Frame: from baseline to 24 hours after consumption and approximately 7 days after consumption
|
Circulating marker of inflammation
|
from baseline to 24 hours after consumption and approximately 7 days after consumption
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Metabolic Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Atherosclerosis
- Coronary Disease
- Lipid Metabolism Disorders
- Dyslipidemias
- Intracranial Arterial Diseases
- Coronary Artery Disease
- Vascular Diseases
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
- Hyperlipidemias
- Cerebral Arterial Diseases
Other Study ID Numbers
- 37096
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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