Cardiovascular DiseaseNCT03267758
Effect of Probiotic Supplementation on Endothelial Function II
A study testing Goodbelly first in people with Cardiovascular Disease and Diabetes Mellitus, Type 2, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
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, the investigators may be able to… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cardiovascular Disease, Diabetes Mellitus, Type 2
- What is being tested?
- Goodbelly first
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 215 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2018to 16 Oct 2025
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
CAD Inclusion Criteria
Age between 40-80 years old History of known coronary artery disease (by either history of myocardial infarction, angiogram demonstrative >=50% stenosis in at least 1 major epicardial coronary artery, or a previous stress test that showed evidence of ischemia that has not been revealed to be a false positive test by angiography)
T2DM without CAD Inclusion Criteria
- Age between 40-80 years old
- History of known Diabetes Mellitus Type II as previously diagnosed by patient's provider (ICD-9/10 code)
CAD 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 a 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 GI tract illness such as short gut syndrome, inflammatory bowel disease, or an ileostomy.
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 is currently taking Vitamin K anatagonists such as coumadin, warfarin.
Those who are daily drinkers or use illicit drugs.
T2DM without CAD Exclusion Criteria
Hgb A1C > 9.5 % Coronary Artery Disease (by either history of myocardial infarction, angiogram demonstrative >=50% stenosis in at least 1 major epicardial coronary artery, or a previous stress test that showed evidence of ischemia that has not been revealed to be a false positive test by angiography) 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 a 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 GI tract illness such as short gut syndrome, inflammatory bowel disease, or an ileostomy.
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 is currently taking Vitamin K anatagonists such as coumadin, warfarin.
Those who are daily drinkers or use illicit drugs.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
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, the investigators 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. The studies proposed will test the hypothesis that altered intestinal microbiota are mechanistically linked to the pathogenesis of cardiovascular disease. The investigator's objective is to determine whether inflammatory markers in the blood are decreased and endothelial cell function improved by a probiotic in patients with established coronary artery disease. Furthermore, the investigators wish to elucidate a mechanism by which the gut microbiota regulates serum inflammatory markers.
- Specific Aim 1 will determine the impact of a probiotic on circulating leptin and TMAO levels, conventional risk factors for cardiovascular disease and diabetes (total cholesterol, LDL cholesterol, oxidized LDL, triglycerides, C-reactive protein, serum amyloid A, fibrinogen and adiponectin, glucose-dependent- insulinotropic polypeptide (GIP), glucagon-like-peptide (GLP-1), glucagon, insulin), and their relationship to the intestinal microbiota (15 representative microbial groups) as non conventional risk factors. Several blood samples will be collected to measure biomarkers. Participants will provide periodic stool samples in order to measure gut bacterial biodiversity. Lastly, endothelial cell function (flow mediated dilation) will be measured in order to assess blood vessel function.
- Specific Aim 2 will determine the impact of a probiotic on metabolites derived from the intestinal microbiota as candidates for non-conventional risk factors of cardiovascular disease. The relationship between metabolites derived from the intestinal microbiota, endothelial cell function and risk factors for cardiovascular disease identified in Specific Aim 1 will be correlated.
Read the detailed description
Recently, a direct link between intestinal microbiota, dietary phosphatidylcholine, and promotion of cardiovascular disease has been elegantly demonstrated. In this study, broad spectrum antibiotics were employed to disrupt the intestinal microbiota, and metabolomic analysis identified 3 metabolites of phosphatidylcholine, including TMAO, linked to atherosclerosis. However, the impact of intestinal dysbiosis on the heart and its susceptibility to injury from ischemia/reperfusion has not been known until now.
Novel work has demonstrated a mechanistic link between changes in the intestinal microbiota and severity of myocardial infarction. Treatment of Dahl S rats with the commercially available probiotic bacterium Lactobacillus plantarum 299v, and a non-absorbed antibiotic vancomycin to alter abundance of multiple microbiota reduced circulating leptin levels, reduced myocardial infarct size, and improved recovery of post-ischemic mechanical function. Pretreatment with leptin abolished cardioprotection by the probiotic and the antibiotic.
These findings also show the reach of the intestinal microbiota extends far beyond local effects to remote organ systems such as the heart and provide support for the metabolomic studies to be conducted in Specific Aim 2. The prior discovery of a relationship between intestinal microbiota, their metabolites and myocardial infarction provides opportunities for novel therapeutic approaches (probiotics, non-absorbable antibiotics and/or microbial metabolites) for the treatment and prevention of cardiovascular disease.
Prior studies indicate an important role of leptin in signaling between the intestinal microbiota and the heart. Supplementation of the diet with active cultures of Lactobacillus plantarum 299v leads to significant reductions in fibrinogen and LDL-cholesterol, and leptin concentrations in smokers. These clinical studies demonstrate that a probiotic is capable of decreasing risk factors for cardiovascular disease. Note that neither leptin nor TMAO levels, per se, are recognized cardiovascular risk factor. This is currently an area with enormous potential for gaining new mechanistic insight and may lead to a therapeutic product or clinical use.
Impaired endothelial function is recognized as an early and modulating process in the pathogenesis of atherosclerotic cardiovascular disease. Furthermore, it has been shown that patients with Type 2 Diabetes Mellitus exhibit endothelial dysfunction and that this phenotype precedes development of frank hyperglycemia. Endothelial function is easily measurable by non-invasive means and endothelial dysfunction measured non-invasively independently predicts future cardiovascular risk in patients both with and without clinically apparent cardiovascular disease. Conduit vessel endothelial function in humans is commonly quantified by measurement of flow-mediated dilation (FMD) in the brachial artery, which represents the endothelium-dependent relaxation of a conduit artery - typically the brachial artery - due to an increased blood flow. FMD correlates with impaired endothelium-dependent relaxation in the coronary arteries and is a commonly recognized "barometer" of cardiovascular risk. Taken together, these data suggest brachial FMD is an ideal surrogate marker of cardiovascular risk to monitor the effects of Lactobacillus plantarum 299v as proposed in this work. Michael Widlansky has extensive experience in the use of FMD to measure endothelial function.
- Conditions
- Cardiovascular Disease, Diabetes Mellitus, Type 2
- Being tested
- Goodbelly first, Placebo first
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goodbelly firstDietary supplement
Also called Goodbelly
Consumption of 1 serving of Goodbelly probiotic daily for 6 weeks. This is followed by 6 weeks of placebo.
Placebo firstDietary supplement
Consumption of 1 serving of probiotic placebo daily for 6 weeks. of 1 serving of Goodbelly probiotic daily for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Goodbelly First | Experimental | Subjects in this arm will consume 1 serving of lactobacillus plantarum 299v daily for first 6 weeks. Receives: Dietary Supplement: Goodbelly first |
| Placebo | Placebo comparator | Subjects in this arm will consume 1 serving of heat-killed placebo daily for first 6 weeks. Receives: Dietary Supplement: Placebo first |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in baseline flow mediated dilation (FMD) at 6 weeks
This is a measurement of endothelial function in the brachial artery
Measured: baseline and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start15 May 2018
- Primary completion16 Oct 2025
- Study completion16 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 215 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
- Investigators
- Michael Widlansky, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267758
- Sponsor's protocol ID
- PRO27955
- Status last verified
- Mar 2026
- First submitted
- 10 Aug 2017
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lam V, Su J, Koprowski S, Hsu A, Tweddell JS, Rafiee P, Gross GJ, Salzman NH, Baker JE. Intestinal microbiota determine severity of myocardial infarction in rats. FASEB J. 2012 Apr;26(4):1727-35. doi: 10.1096/fj.11-197921. Epub 2012 Jan 12.
PubMed 22247331Naruszewicz M, Johansson ML, Zapolska-Downar D, Bukowska H. Effect of Lactobacillus plantarum 299v on cardiovascular disease risk factors in smokers. Am J Clin Nutr. 2002 Dec;76(6):1249-55. doi: 10.1093/ajcn/76.6.1249.
PubMed 12450890Widlansky ME, Gokce N, Keaney JF Jr, Vita JA. The clinical implications of endothelial dysfunction. J Am Coll Cardiol. 2003 Oct 1;42(7):1149-60. doi: 10.1016/s0735-1097(03)00994-x.
PubMed 14522472Corretti MC, Anderson TJ, Benjamin EJ, Celermajer D, Charbonneau F, Creager MA, Deanfield J, Drexler H, Gerhard-Herman M, Herrington D, Vallance P, Vita J, Vogel R; International Brachial Artery Reactivity Task Force. Guidelines for the ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery: a report of the International Brachial Artery Reactivity Task Force. J Am Coll Cardiol. 2002 Jan 16;39(2):257-65. doi: 10.1016/s0735-1097(01)01746-6.
PubMed 11788217Celermajer DS, Sorensen KE, Gooch VM, Spiegelhalter DJ, Miller OI, Sullivan ID, Lloyd JK, Deanfield JE. Non-invasive detection of endothelial dysfunction in children and adults at risk of atherosclerosis. Lancet. 1992 Nov 7;340(8828):1111-5. doi: 10.1016/0140-6736(92)93147-f.
PubMed 1359209Thijssen DH, Black MA, Pyke KE, Padilla J, Atkinson G, Harris RA, Parker B, Widlansky ME, Tschakovsky ME, Green DJ. Assessment of flow-mediated dilation in humans: a methodological and physiological guideline. Am J Physiol Heart Circ Physiol. 2011 Jan;300(1):H2-12. doi: 10.1152/ajpheart.00471.2010. Epub 2010 Oct 15.
PubMed 20952670Takase B, Uehata A, Akima T, Nagai T, Nishioka T, Hamabe A, Satomura K, Ohsuzu F, Kurita A. Endothelium-dependent flow-mediated vasodilation in coronary and brachial arteries in suspected coronary artery disease. Am J Cardiol. 1998 Dec 15;82(12):1535-9, A7-8. doi: 10.1016/s0002-9149(98)00702-4.
PubMed 9874063Vita JA, Keaney JF Jr. Endothelial function: a barometer for cardiovascular risk? Circulation. 2002 Aug 6;106(6):640-2. doi: 10.1161/01.cir.0000028581.07992.56. No abstract available.
PubMed 12163419Tang WH, Wang Z, Levison BS, Koeth RA, Britt EB, Fu X, Wu Y, Hazen SL. Intestinal microbial metabolism of phosphatidylcholine and cardiovascular risk. N Engl J Med. 2013 Apr 25;368(17):1575-84. doi: 10.1056/NEJMoa1109400.
PubMed 23614584
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic Supplementation on Endothelial Function II
- ClinicalTrials.gov ID
- NCT03267758
- Acronym / sponsor ID
- PRO27955
- Conditions
- Cardiovascular Disease, Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 16 Oct 2025 (actual)
- First posted
- 30 Aug 2017 (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.
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, the investigators 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. The studies proposed will test the hypothesis that altered intestinal microbiota are mechanistically linked to the pathogenesis of cardiovascular disease. The investigator's objective is to determine whether inflammatory markers in the blood are decreased and endothelial cell function improved by a probiotic in patients with established coronary artery disease. Furthermore, the investigators wish to elucidate a mechanism by which the gut microbiota regulates serum inflammatory markers.
- Specific Aim 1 will determine the impact of a probiotic on circulating leptin and TMAO levels, conventional risk factors for cardiovascular disease and diabetes (total cholesterol, LDL cholesterol, oxidized LDL, triglycerides, C-reactive protein, serum amyloid A, fibrinogen and adiponectin, glucose-dependent- insulinotropic polypeptide (GIP), glucagon-like-peptide (GLP-1), glucagon, insulin), and their relationship to the intestinal microbiota (15 representative microbial groups) as non conventional risk factors. Several blood samples will be collected to measure biomarkers. Participants will provide periodic stool samples in order to measure gut bacterial biodiversity. Lastly, endothelial cell function (flow mediated dilation) will be measured in order to assess blood vessel function.
- Specific Aim 2 will determine the impact of a probiotic on metabolites derived from the intestinal microbiota as candidates for non-conventional risk factors of cardiovascular disease. The relationship between metabolites derived from the intestinal microbiota, endothelial cell function and risk factors for cardiovascular disease identified in Specific Aim 1 will be correlated.
Detailed description
Recently, a direct link between intestinal microbiota, dietary phosphatidylcholine, and promotion of cardiovascular disease has been elegantly demonstrated. In this study, broad spectrum antibiotics were employed to disrupt the intestinal microbiota, and metabolomic analysis identified 3 metabolites of phosphatidylcholine, including TMAO, linked to atherosclerosis. However, the impact of intestinal dysbiosis on the heart and its susceptibility to injury from ischemia/reperfusion has not been known until now.
Novel work has demonstrated a mechanistic link between changes in the intestinal microbiota and severity of myocardial infarction. Treatment of Dahl S rats with the commercially available probiotic bacterium Lactobacillus plantarum 299v, and a non-absorbed antibiotic vancomycin to alter abundance of multiple microbiota reduced circulating leptin levels, reduced myocardial infarct size, and improved recovery of post-ischemic mechanical function. Pretreatment with leptin abolished cardioprotection by the probiotic and the antibiotic.
These findings also show the reach of the intestinal microbiota extends far beyond local effects to remote organ systems such as the heart and provide support for the metabolomic studies to be conducted in Specific Aim 2. The prior discovery of a relationship between intestinal microbiota, their metabolites and myocardial infarction provides opportunities for novel therapeutic approaches (probiotics, non-absorbable antibiotics and/or microbial metabolites) for the treatment and prevention of cardiovascular disease.
Prior studies indicate an important role of leptin in signaling between the intestinal microbiota and the heart. Supplementation of the diet with active cultures of Lactobacillus plantarum 299v leads to significant reductions in fibrinogen and LDL-cholesterol, and leptin concentrations in smokers. These clinical studies demonstrate that a probiotic is capable of decreasing risk factors for cardiovascular disease. Note that neither leptin nor TMAO levels, per se, are recognized cardiovascular risk factor. This is currently an area with enormous potential for gaining new mechanistic insight and may lead to a therapeutic product or clinical use.
Impaired endothelial function is recognized as an early and modulating process in the pathogenesis of atherosclerotic cardiovascular disease. Furthermore, it has been shown that patients with Type 2 Diabetes Mellitus exhibit endothelial dysfunction and that this phenotype precedes development of frank hyperglycemia. Endothelial function is easily measurable by non-invasive means and endothelial dysfunction measured non-invasively independently predicts future cardiovascular risk in patients both with and without clinically apparent cardiovascular disease. Conduit vessel endothelial function in humans is commonly quantified by measurement of flow-mediated dilation (FMD) in the brachial artery, which represents the endothelium-dependent relaxation of a conduit artery - typically the brachial artery - due to an increased blood flow. FMD correlates with impaired endothelium-dependent relaxation in the coronary arteries and is a commonly recognized "barometer" of cardiovascular risk. Taken together, these data suggest brachial FMD is an ideal surrogate marker of cardiovascular risk to monitor the effects of Lactobacillus plantarum 299v as proposed in this work. Michael Widlansky has extensive experience in the use of FMD to measure endothelial function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goodbelly First | Experimental | Dietary Supplement: Goodbelly firstSubjects in this arm will consume 1 serving of lactobacillus plantarum 299v daily for first 6 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo firstSubjects in this arm will consume 1 serving of heat-killed placebo daily for first 6 weeks. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Goodbelly firstAlso: GoodbellyConsumption of 1 serving of Goodbelly probiotic daily for 6 weeks. This is followed by 6 weeks of placebo. | Dietary supplement | Goodbelly First |
| Placebo firstConsumption of 1 serving of probiotic placebo daily for 6 weeks. of 1 serving of Goodbelly probiotic daily for 6 weeks. | Dietary supplement | Placebo |
Primary outcome
change in baseline flow mediated dilation (FMD) at 6 weeks
Time frame: baseline and week 6
This is a measurement of endothelial function in the brachial artery
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 24 Mar 2026.
- Background: PubMed 22247331Lam V, Su J, Koprowski S, Hsu A, Tweddell JS, Rafiee P, Gross GJ, Salzman NH, Baker JE. Intestinal microbiota determine severity of myocardial infarction in rats. FASEB J. 2012 Apr;26(4):1727-35. doi: 10.1096/fj.11-197921. Epub 2012 Jan 12.
- Background: PubMed 12450890Naruszewicz M, Johansson ML, Zapolska-Downar D, Bukowska H. Effect of Lactobacillus plantarum 299v on cardiovascular disease risk factors in smokers. Am J Clin Nutr. 2002 Dec;76(6):1249-55. doi: 10.1093/ajcn/76.6.1249.
- Background: PubMed 14522472Widlansky ME, Gokce N, Keaney JF Jr, Vita JA. The clinical implications of endothelial dysfunction. J Am Coll Cardiol. 2003 Oct 1;42(7):1149-60. doi: 10.1016/s0735-1097(03)00994-x.
- Background: PubMed 11788217Corretti MC, Anderson TJ, Benjamin EJ, Celermajer D, Charbonneau F, Creager MA, Deanfield J, Drexler H, Gerhard-Herman M, Herrington D, Vallance P, Vita J, Vogel R; International Brachial Artery Reactivity Task Force. Guidelines for the ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery: a report of the International Brachial Artery Reactivity Task Force. J Am Coll Cardiol. 2002 Jan 16;39(2):257-65. doi: 10.1016/s0735-1097(01)01746-6.
- Background: PubMed 1359209Celermajer DS, Sorensen KE, Gooch VM, Spiegelhalter DJ, Miller OI, Sullivan ID, Lloyd JK, Deanfield JE. Non-invasive detection of endothelial dysfunction in children and adults at risk of atherosclerosis. Lancet. 1992 Nov 7;340(8828):1111-5. doi: 10.1016/0140-6736(92)93147-f.
- Background: PubMed 20952670Thijssen DH, Black MA, Pyke KE, Padilla J, Atkinson G, Harris RA, Parker B, Widlansky ME, Tschakovsky ME, Green DJ. Assessment of flow-mediated dilation in humans: a methodological and physiological guideline. Am J Physiol Heart Circ Physiol. 2011 Jan;300(1):H2-12. doi: 10.1152/ajpheart.00471.2010. Epub 2010 Oct 15.
- Background: PubMed 9874063Takase B, Uehata A, Akima T, Nagai T, Nishioka T, Hamabe A, Satomura K, Ohsuzu F, Kurita A. Endothelium-dependent flow-mediated vasodilation in coronary and brachial arteries in suspected coronary artery disease. Am J Cardiol. 1998 Dec 15;82(12):1535-9, A7-8. doi: 10.1016/s0002-9149(98)00702-4.
- Background: PubMed 12163419Vita JA, Keaney JF Jr. Endothelial function: a barometer for cardiovascular risk? Circulation. 2002 Aug 6;106(6):640-2. doi: 10.1161/01.cir.0000028581.07992.56. No abstract available.
- Results publication: PubMed 23614584Tang WH, Wang Z, Levison BS, Koeth RA, Britt EB, Fu X, Wu Y, Hazen SL. Intestinal microbial metabolism of phosphatidylcholine and cardiovascular risk. N Engl J Med. 2013 Apr 25;368(17):1575-84. doi: 10.1056/NEJMoa1109400.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiovascular Disease
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Recruiting
Systematic Ambulatory ECG Monitoring Following TAVI
Aortic Stenosis, Conduction Disturbances
Recruiting
Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD)
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Active, not recruiting
Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)
Acute Ischemic Stroke
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.
Michael Widlansky, MD principal investigator
Medical College of Wisconsin
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 first in people with Cardiovascular Disease and Diabetes Mellitus, Type 2, 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?
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 24 Mar 2026. 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) at 6 weeks (time frame: baseline and week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03267758, which also lists 9 linked publications.
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 24 Mar 2026.