Coronary Artery DiseaseNCT04364074
Acute Probiotic Supplementation and Endothelial Function
A study testing Goodbelly in people with Coronary Artery Disease and Hypertension, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
One in every two deaths in the United States is caused by cardiovascular disease. Despite strong mechanistic links established between a diet rich in lipids and the pathogenesis of cardiovascular disease, therapeutic advances have focused on reduction in either ingestion or synthesis of cholesterol, and reduction in… Read more about this study
- Who is it for?
- Ages 21 to 89 years
- Conditions the study is for
- Coronary Artery Disease, Hypertension, Hyperlipidemias
- What is being tested?
- Goodbelly
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2020to 3 Aug 2023
- Phase
- Interventional
- 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 21 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have at least one of the following conditions:
- Hypertension
- Hyperlipidemia
- Diabetes mellitus (Type 1 or Type 2)
- Peripheral vascular disease
- Cerebrovascular disease
- Cardiovascular disease.
Who cannot join
- 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.
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Wauwatosa, Wisconsin, 53222
About this study
Official title: Acute Impact of Probiotic Supplementation on Endothelial Function in Adults
One in every two deaths in the United States is caused by cardiovascular disease. Despite strong mechanistic links established between a diet rich in lipids and the pathogenesis of cardiovascular disease, therapeutic advances have focused on reduction in either ingestion or synthesis of cholesterol, and reduction in dietary trans and saturated fatty acids and triglycerides. Even in the setting of aggressive high potency statin therapy and global cardiovascular risk reduction efforts, most clinical trials reveal a significant residual cardiovascular risk with, at best, only 30% reduction in major adverse cardiovascular events. There exists a significant unmet clinical need for identifying novel therapies for the prevention and treatment of cardiovascular disease. This requires identification of additional contributory processes to cardiovascular disease pathogenesis, so that mechanism-based interventions may be developed. Endothelial dysfunction is a pathological state in which there is systemic inflammation of vascular endothelium with consequent expression of pro-vasoconstrictive mediators, thrombotic and atherogenic tendencies. Endothelial dysfunction precedes the development of atherosclerosis and portends an increased risk of future adverse cardiovascular events. Endothelial dysfunction, therefore, can serve as a "barometer" of future cardiovascular risk. Measurement of Flow-mediated dilation ( FMD) is widely accepted as a method to assess vascular endothelial function.
Read the 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.
- Conditions
- Coronary Artery Disease, Hypertension, Hyperlipidemias, Peripheral Vascular Diseases, Cerebral Arterial Diseases
- Being tested
- Goodbelly, Placebo
- Medical subject headings
- Coronary Artery Disease, Hypertension, Hyperlipidemias, Peripheral Vascular Diseases, Cerebral Arterial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GoodbellyDietary supplement
Also called Goodbelly probiotic
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.
PlaceboDietary supplement
Also called Goodbelly Probitoic
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
| Study group | Role | What they receive |
|---|---|---|
| GoodBelly Probiotic | Experimental | Subjects randomized to this arm consume one serving of the Goodbelly lactobacillus plantarum 299v probiotic Receives: Dietary Supplement: Goodbelly |
| Placebo | Placebo comparator | Subjects randomized to this arm consume one serving of the Goodbelly that does not contain lactobacillus plantarum 299v Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in baseline flow mediated dilation (FMD) after probiotic consumption
This is a measurement of endothelial function in the brachial artery
Measured: from baseline to 24 hours after consumption and approximately 7 days after consumption
Secondary outcomes (3)
Interleukin-6
Circulating marker of inflammation
Measured: from baseline to 24 hours after consumption and approximately 7 days after consumption
Interleukin-8
Circulating marker of inflammation
Measured: from baseline to 24 hours after consumption and approximately 7 days after consumption
Interleukin-12
Circulating marker of inflammation
Measured: from baseline to 24 hours after consumption and approximately 7 days after consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start17 Aug 2020
- Primary completion22 Sep 2022
- Study completion3 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael E. Widlansky, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364074
- Sponsor's protocol ID
- 37096
- Status last verified
- Aug 2023
- First submitted
- 24 Apr 2020
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Impact of Probiotic Supplementation on Endothelial Function in Adults
- ClinicalTrials.gov ID
- NCT04364074
- Acronym / sponsor ID
- 37096
- Conditions
- Coronary Artery Disease, Hypertension, Hyperlipidemias, Peripheral Vascular Diseases, Cerebral Arterial Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 27 Apr 2020 (actual)
- 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.
One in every two deaths in the United States is caused by cardiovascular disease. Despite strong mechanistic links established between a diet rich in lipids and the pathogenesis of cardiovascular disease, therapeutic advances have focused on reduction in either ingestion or synthesis of cholesterol, and reduction in dietary trans and saturated fatty acids and triglycerides. Even in the setting of aggressive high potency statin therapy and global cardiovascular risk reduction efforts, most clinical trials reveal a significant residual cardiovascular risk with, at best, only 30% reduction in major adverse cardiovascular events. There exists a significant unmet clinical need for identifying novel therapies for the prevention and treatment of cardiovascular disease. This requires identification of additional contributory processes to cardiovascular disease pathogenesis, so that mechanism-based interventions may be developed. Endothelial dysfunction is a pathological state in which there is systemic inflammation of vascular endothelium with consequent expression of pro-vasoconstrictive mediators, thrombotic and atherogenic tendencies. Endothelial dysfunction precedes the development of atherosclerosis and portends an increased risk of future adverse cardiovascular events. Endothelial dysfunction, therefore, can serve as a "barometer" of future cardiovascular risk. Measurement of Flow-mediated dilation ( FMD) is widely accepted as a method to assess vascular endothelial function.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GoodBelly Probiotic | Experimental | Dietary Supplement: GoodbellySubjects randomized to this arm consume one serving of the Goodbelly lactobacillus plantarum 299v probiotic |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSubjects randomized to this arm consume one serving of the Goodbelly that does not contain lactobacillus plantarum 299v |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hypertension
- Hyperlipidemia
- Diabetes mellitus (Type 1 or Type 2)
- Peripheral vascular disease
- Cerebrovascular disease
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| GoodbellyAlso: Goodbelly probioticConsumption 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. | Dietary supplement | GoodBelly Probiotic |
| PlaceboAlso: Goodbelly ProbitoicTo 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 | Dietary supplement | Placebo |
Primary outcome
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
This is a measurement of endothelial function in the brachial artery
3 secondary outcomes
Interleukin-6
Time frame: from baseline to 24 hours after consumption and approximately 7 days after consumption
Interleukin-8
Time frame: from baseline to 24 hours after consumption and approximately 7 days after consumption
Interleukin-12
Time frame: from baseline to 24 hours after consumption and approximately 7 days after consumption
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 22 Aug 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goodbelly in people with Coronary Artery Disease and Hypertension, run by Medical College of Wisconsin at 1 site in United States.
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 7 inclusion and 12 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 22 Aug 2023. 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 United States. 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.
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?
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). 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 22 Aug 2023.