Heart FailureNCT05752760
Pilot Study Lp299v Supplementation in Chronic Heart Failure
A study testing Lactobacillus Plantarum 299v Freeze Dried Capsule and Freeze Dried Potato Starch Capsule in people with Heart Failure and Heart Failure With Reduced Ejection Fraction, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The goal of this study is to determine the impact of 12 weeks of Lp299v supplementation (20 million cfu/day vs. placebo) on exercise capacity, circulating biomarkers of cardiac remodeling, quality of life, and vascular endothelial function in humans with heart failure and reduced ejection fraction (HFrEF) and heart… Read more about this study
- Who is it for?
- Ages 21 to 89 years
- Conditions the study is for
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure, Systolic
- What is being tested?
- Lactobacillus Plantarum 299v Freeze Dried Capsule and Freeze Dried Potato Starch Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2023to 1 Mar 2026
- 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
- Age between 21-89 years old
- Clinical diagnosis of Congestive Heart Failure (CHF) in the six months prior to enrollment along with an echocardiogram documenting systolic dysfunction with ejection fraction ≤40%
- Clinical diagnosis of CHF in the six months prior to enrollment along with an echocardiogram documenting diastolic dysfunction with an ejection fraction ≥50%, and a H2FpEFF score of ≥6
- New York Heart Association (NYHA) Class II-IIID heart failure symptoms with either ischemic or non-ischemic etiology OR similar diagnosis with congestive heart failure (CHF) along with an echocardiogram documenting an LV ejection fraction of 50% or more with similar NYHA classification as those with LVEF of 40% or less
- Evidence of systemic inflammation at baseline (C-reactive protein ≥ 2 mg/L at the time of screening)
Who cannot join
- Heart failure due to severe valve disease such as Aortic Stenosis, Mitral Regurgitation, or Mitral Stenosis
- Cancer besides non-melanoma skin carcinomas or localized prostate and breast cancer at the time of enrollment with life expectancy <1 year
- Lung disease such as Chronic Obstructive Pulmonary Disease (COPD), emphysema, or Pulmonary fibrosis
- Active inflammatory disease or infectious disease at the time of enrollment
- Current treatment (or use within the past 14 days) of steroids or anti-inflammatory treatments (excluding non-steroidal anti-inflammatory medications or steroids used solely for IV contrast dye allergy)
- Chronic Kidney Disease with eGFR ≤ 30 mL/min
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- Hepatic Failure (Child's Class B or C)
- Patients with Gastrointestinal (GI) tract illness such as short gut syndrome, inflammatory bowel disease, or an ileostomy, such that probiotic absorption would be altered
- Anticipated need for cardiac surgery during the projected study period for the subject
- Pregnancy
- Patients who are receiving Vitamin K antagonists such as Coumadin or Warfarin
- Neutropenia (Absolute Neutrophil Count (ANC) < 1800/mm3)
- Inability to give informed consent or follow the study protocol
- On antibiotics at the time of enrollment or within one month of enrollment
- Currently taking a Lactobacillus based probiotic as an outpatient at the time of enrollment
- Patients who are unable to walk on treadmill or use a bicycle to participate in exercise testing
- Allergy to Lp299v probiotic supplement
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Impact of Lactobacillus Plantarum 299v Probiotic Supplementation on Vascular Function and Exercise Capacity in Chronic Heart Failure With Reduced and Preserved Ejection Fraction.
The goal of this study is to determine the impact of 12 weeks of Lp299v supplementation (20 million cfu/day vs. placebo) on exercise capacity, circulating biomarkers of cardiac remodeling, quality of life, and vascular endothelial function in humans with heart failure and reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) who have evidence of residual inflammation based on an elevated C-reactive protein level. This will be done in the setting of a randomized, double-blind, placebo-controlled trial.
Read the detailed description
Heart failure (HF) has significant morbidity and mortality and is one of the leading causes of hospital admissions in the United States. In 2017, almost 1 million people were affected and responsible for 1.2 million hospitalizations in the United States alone. Prognosis is poor for patients with HF despite significant medical therapy regimens and device therapy. Worldwide, mortality is as high as 17% during initial hospitalization, as high as 45% within one year of admission, and greater than 50% within five years. According to the Wisconsin Department of Health Services, mortality rates for HF have been increasing in the state since 1980. Wisconsin also consistently had higher rates of HF compared to the remaining states.
Emerging data suggest targeting the gut microbiota in HF could be a safe and effective alternative for mitigating inflammation. HF patients have increased systemic circulating endotoxins and lipopolysaccharides due to impaired gut-barrier function, secondary to gut congestion and reduced cardiac output, which drives systemic inflammation. The gut flora of patients with HF also includes more pathogenic bacteria species (candida, campylobacter, shigella, and yersinia) compared to patients with normal heart function.
Previous studies by the lab showed that supplementation of 20 billion cfu/day of Lactobacillus plantarum 299v (Lp299v) probiotic decreases systemic inflammation in men with stable coronary artery disease (CAD), and also improves vascular endothelial function (measured by endothelium-dependent vasodilation in the brachial artery and by nitric-oxide dependent vasodilation of resistance arterioles from CAD patients). The investigators have shown that there are significantly decreased levels of IL-8, IL-12 and Leptin in Lp299v-supplemented patients with CAD. Leptin is known to increase IL-6 (which drives increased C-reactive protein expression), IL-8, IL-12 and TNF-α levels, all which activate pro-inflammatory immune responses leading to vasoconstriction and vascular stiffness. Further, our data suggests Lp299v has a significant, favorable anti-inflammatory effect on signaling pathways (NLRP3, IL-6, IL-1β) shown to be important to chronic inflammation in heart failure.
Therefore, the investigators plan to perform a pilot study targeting the gut microbiota of patients with HF with oral supplementation with 20 billion cfu/day of Lp299 and determine if Lp299v improves peak oxygen consumption (measured by VO2 max testing), endothelial function (measured by brachial artery flow-mediated dilation), and vascular stiffness (measured by peak wave velocity). We plan to test the hypothesis that Lp299v will improve these measures in the setting of a randomized, double-blind, placebo-controlled clinical trial of 20 subjects. The investigators will additionally test if Lp299v supplementation improves circulating biomarkers of inflammation and cardiac remodeling in chronic heart failure, as well as if it improves the quality of life in patients using the Minnesota Living with Heart Failure Questionnaire and the Kansas City Cardiomyopathy Questionnaire.
- Conditions
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure, Systolic, Heart Failure With Preserved Ejection Fraction, Heart Failure, Diastolic
- Being tested
- Lactobacillus Plantarum 299v Freeze Dried Capsule, Freeze Dried Potato Starch Capsule
- Keywords
- Endothelial Function, Microbiome, Heart Failure, Ejection Fraction
- Medical subject headings
- Heart Failure, Heart Failure, Systolic, Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus Plantarum 299v Freeze Dried CapsuleOther
The intervention is a probiotic lactobacillus that is contained in food products in the US
Freeze Dried Potato Starch CapsuleOther
The intervention is potato starch that is freeze dried designed to mimic the lp299v capsule.
| Study group | Role | What they receive |
|---|---|---|
| Lp299v | Experimental | Subjects will consume 20 billion colony forming units of Lp299v (2 capsules) once daily for 12 weeks. Receives: Other: Lactobacillus Plantarum 299v Freeze Dried Capsule |
| Placebo Control | Placebo comparator | Subjects will consume potato starch (2 capsules) once daily for 12 weeks. Receives: Other: Freeze Dried Potato Starch Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Oxygen Consumption (VO2Max)
This is a measurement of exercise capacity
Measured: 12 weeks
Brachial Artery Flow Mediated Dilation (FMD%)
This is a measurement of endothelial function in the brachial artery
Measured: 12 weeks
Carotid-Femoral Pulse Wave Velocity (cfPWV)
Measurement of vascular stiffness
Measured: 12 weeks
Secondary outcomes (7)
Brachial Artery Absolute Flow Mediated Dilation (FMDmm)
This is a measurement of endothelial function in the brachial artery
Measured: 12 weeks
Resting shear stress of brachial artery
This is a measurement of vascular stiffness
Measured: 12 weeks
Resting velocity
This is a measurement of vascular stiffness
Measured: 12 weeks
Change in serum Soluble Suppression Tumorigenesis (SST2)
This measures cardiac fibrosis
Measured: 12 weeks
Peak flow velocity
This is a measurement of vascular stiffness
Measured: 12 weeks
Peak Hyperemic Shear Stress of Brachial Artery
This is a measurement of vascular stiffness
Measured: 12 weeks
Change in Galectin-3
This measures cardiac fibrosis
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start20 Feb 2023
- Primary completion31 Mar 2025
- Study completion1 Mar 2026
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 Heart FailureStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Advancing a Healthier Wisconsin Endowment
- Responsible party
- Principal investigator, Michael E. Widlansky, Medical College of Wisconsin
- Investigators
- Michael E Widlansky, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752760
- Sponsor's protocol ID
- 45284
- Status last verified
- Apr 2026
- First submitted
- 21 Feb 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Agarwal MA, Fonarow GC, Ziaeian B. National Trends in Heart Failure Hospitalizations and Readmissions From 2010 to 2017. JAMA Cardiol. 2021 Aug 1;6(8):952-956. doi: 10.1001/jamacardio.2020.7472.
PubMed 33566058Dick SA, Epelman S. Chronic Heart Failure and Inflammation: What Do We Really Know? Circ Res. 2016 Jun 24;119(1):159-76. doi: 10.1161/CIRCRESAHA.116.308030.
PubMed 27340274Wisconsin Heart Disease and Stroke Prevention Program, February 2010. www.dhs.wisconsin.gov/publications/p0/p00146.pdf
Pasini E, Aquilani R, Testa C, Baiardi P, Angioletti S, Boschi F, Verri M, Dioguardi F. Pathogenic Gut Flora in Patients With Chronic Heart Failure. JACC Heart Fail. 2016 Mar;4(3):220-7. doi: 10.1016/j.jchf.2015.10.009. Epub 2015 Dec 9.
PubMed 26682791Hofeld BC, Puppala VK, Tyagi S, Ahn KW, Anger A, Jia S, Salzman NH, Hessner MJ, Widlansky ME. Lactobacillus plantarum 299v probiotic supplementation in men with stable coronary artery disease suppresses systemic inflammation. Sci Rep. 2021 Feb 17;11(1):3972. doi: 10.1038/s41598-021-83252-7.
PubMed 33597583Iikuni N, Lam QL, Lu L, Matarese G, La Cava A. Leptin and Inflammation. Curr Immunol Rev. 2008 May 1;4(2):70-79. doi: 10.2174/157339508784325046.
PubMed 20198122Santos-Alvarez J, Goberna R, Sanchez-Margalet V. Human leptin stimulates proliferation and activation of human circulating monocytes. Cell Immunol. 1999 May 25;194(1):6-11. doi: 10.1006/cimm.1999.1490.
PubMed 10357875Spertus, J., Kansas City Cardiomyopathy Questionnaire MDDT decision summary. <fda.gov>
Thomas, R, Cohn, J., Minnesota Living with Heart Failure Questionnaire <license.umn.edu/product/minnesota-living-with-heart-fialure-questionnaire-mlhfq>
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Lactobacillus Plantarum 299v Probiotic Supplementation on Vascular Function and Exercise Capacity in Chronic Heart Failure With Reduced and Preserved Ejection Fraction.
- ClinicalTrials.gov ID
- NCT05752760
- Acronym / sponsor ID
- 45284
- Conditions
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure, Systolic, Heart Failure With Preserved Ejection Fraction, Heart Failure, Diastolic
- Keywords
- Endothelial Function, Microbiome, Heart Failure, Ejection Fraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Advancing a Healthier Wisconsin Endowment
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 3 Mar 2023 (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.
The goal of this study is to determine the impact of 12 weeks of Lp299v supplementation (20 million cfu/day vs. placebo) on exercise capacity, circulating biomarkers of cardiac remodeling, quality of life, and vascular endothelial function in humans with heart failure and reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) who have evidence of residual inflammation based on an elevated C-reactive protein level. This will be done in the setting of a randomized, double-blind, placebo-controlled trial.
Detailed description
Heart failure (HF) has significant morbidity and mortality and is one of the leading causes of hospital admissions in the United States. In 2017, almost 1 million people were affected and responsible for 1.2 million hospitalizations in the United States alone. Prognosis is poor for patients with HF despite significant medical therapy regimens and device therapy. Worldwide, mortality is as high as 17% during initial hospitalization, as high as 45% within one year of admission, and greater than 50% within five years. According to the Wisconsin Department of Health Services, mortality rates for HF have been increasing in the state since 1980. Wisconsin also consistently had higher rates of HF compared to the remaining states.
Emerging data suggest targeting the gut microbiota in HF could be a safe and effective alternative for mitigating inflammation. HF patients have increased systemic circulating endotoxins and lipopolysaccharides due to impaired gut-barrier function, secondary to gut congestion and reduced cardiac output, which drives systemic inflammation. The gut flora of patients with HF also includes more pathogenic bacteria species (candida, campylobacter, shigella, and yersinia) compared to patients with normal heart function.
Previous studies by the lab showed that supplementation of 20 billion cfu/day of Lactobacillus plantarum 299v (Lp299v) probiotic decreases systemic inflammation in men with stable coronary artery disease (CAD), and also improves vascular endothelial function (measured by endothelium-dependent vasodilation in the brachial artery and by nitric-oxide dependent vasodilation of resistance arterioles from CAD patients). The investigators have shown that there are significantly decreased levels of IL-8, IL-12 and Leptin in Lp299v-supplemented patients with CAD. Leptin is known to increase IL-6 (which drives increased C-reactive protein expression), IL-8, IL-12 and TNF-α levels, all which activate pro-inflammatory immune responses leading to vasoconstriction and vascular stiffness. Further, our data suggests Lp299v has a significant, favorable anti-inflammatory effect on signaling pathways (NLRP3, IL-6, IL-1β) shown to be important to chronic inflammation in heart failure.
Therefore, the investigators plan to perform a pilot study targeting the gut microbiota of patients with HF with oral supplementation with 20 billion cfu/day of Lp299 and determine if Lp299v improves peak oxygen consumption (measured by VO2 max testing), endothelial function (measured by brachial artery flow-mediated dilation), and vascular stiffness (measured by peak wave velocity). We plan to test the hypothesis that Lp299v will improve these measures in the setting of a randomized, double-blind, placebo-controlled clinical trial of 20 subjects. The investigators will additionally test if Lp299v supplementation improves circulating biomarkers of inflammation and cardiac remodeling in chronic heart failure, as well as if it improves the quality of life in patients using the Minnesota Living with Heart Failure Questionnaire and the Kansas City Cardiomyopathy Questionnaire.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lp299v | Experimental | Other: Lactobacillus Plantarum 299v Freeze Dried CapsuleSubjects will consume 20 billion colony forming units of Lp299v (2 capsules) once daily for 12 weeks. |
| Placebo Control | Placebo comparator | Other: Freeze Dried Potato Starch CapsuleSubjects will consume potato starch (2 capsules) once daily for 12 weeks. |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 21-89 years old
- Clinical diagnosis of Congestive Heart Failure (CHF) in the six months prior to enrollment along with an echocardiogram documenting systolic dysfunction with ejection fraction ≤40%
- Clinical diagnosis of CHF in the six months prior to enrollment along with an echocardiogram documenting diastolic dysfunction with an ejection fraction ≥50%, and a H2FpEFF score of ≥6
- New York Heart Association (NYHA) Class II-IIID heart failure symptoms with either ischemic or non-ischemic etiology OR similar diagnosis with congestive heart failure (CHF) along with an echocardiogram documenting an LV ejection fraction of 50% or more with similar NYHA classification as those with LVEF of 40% or less
- Evidence of systemic inflammation at baseline (C-reactive protein ≥ 2 mg/L at the time of screening)
Key exclusion criteria (17 listed)
- Heart failure due to severe valve disease such as Aortic Stenosis, Mitral Regurgitation, or Mitral Stenosis
- Cancer besides non-melanoma skin carcinomas or localized prostate and breast cancer at the time of enrollment with life expectancy <1 year
- Lung disease such as Chronic Obstructive Pulmonary Disease (COPD), emphysema, or Pulmonary fibrosis
- Active inflammatory disease or infectious disease at the time of enrollment
- Current treatment (or use within the past 14 days) of steroids or anti-inflammatory treatments (excluding non-steroidal anti-inflammatory medications or steroids used solely for IV contrast dye allergy)
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 |
|---|---|---|
| Lactobacillus Plantarum 299v Freeze Dried CapsuleThe intervention is a probiotic lactobacillus that is contained in food products in the US | Other | Lp299v |
| Freeze Dried Potato Starch CapsuleThe intervention is potato starch that is freeze dried designed to mimic the lp299v capsule. | Other | Placebo Control |
Primary outcome
Maximal Oxygen Consumption (VO2Max)
Time frame: 12 weeks
This is a measurement of exercise capacity
Brachial Artery Flow Mediated Dilation (FMD%)
Time frame: 12 weeks
This is a measurement of endothelial function in the brachial artery
Carotid-Femoral Pulse Wave Velocity (cfPWV)
Time frame: 12 weeks
Measurement of vascular stiffness
7 secondary outcomes
Brachial Artery Absolute Flow Mediated Dilation (FMDmm)
Time frame: 12 weeks
Resting shear stress of brachial artery
Time frame: 12 weeks
Resting velocity
Time frame: 12 weeks
Change in serum Soluble Suppression Tumorigenesis (SST2)
Time frame: 12 weeks
Peak flow velocity
Time frame: 12 weeks
Peak Hyperemic Shear Stress of Brachial Artery
Time frame: 12 weeks
Change in Galectin-3
Time frame: 12 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 1 May 2026.
- Background: PubMed 33566058Agarwal MA, Fonarow GC, Ziaeian B. National Trends in Heart Failure Hospitalizations and Readmissions From 2010 to 2017. JAMA Cardiol. 2021 Aug 1;6(8):952-956. doi: 10.1001/jamacardio.2020.7472.
- Background: PubMed 27340274Dick SA, Epelman S. Chronic Heart Failure and Inflammation: What Do We Really Know? Circ Res. 2016 Jun 24;119(1):159-76. doi: 10.1161/CIRCRESAHA.116.308030.
- BackgroundWisconsin Heart Disease and Stroke Prevention Program, February 2010. www.dhs.wisconsin.gov/publications/p0/p00146.pdf
- Background: PubMed 26682791Pasini E, Aquilani R, Testa C, Baiardi P, Angioletti S, Boschi F, Verri M, Dioguardi F. Pathogenic Gut Flora in Patients With Chronic Heart Failure. JACC Heart Fail. 2016 Mar;4(3):220-7. doi: 10.1016/j.jchf.2015.10.009. Epub 2015 Dec 9.
- Background: PubMed 33597583Hofeld BC, Puppala VK, Tyagi S, Ahn KW, Anger A, Jia S, Salzman NH, Hessner MJ, Widlansky ME. Lactobacillus plantarum 299v probiotic supplementation in men with stable coronary artery disease suppresses systemic inflammation. Sci Rep. 2021 Feb 17;11(1):3972. doi: 10.1038/s41598-021-83252-7.
- Background: PubMed 20198122Iikuni N, Lam QL, Lu L, Matarese G, La Cava A. Leptin and Inflammation. Curr Immunol Rev. 2008 May 1;4(2):70-79. doi: 10.2174/157339508784325046.
- Background: PubMed 10357875Santos-Alvarez J, Goberna R, Sanchez-Margalet V. Human leptin stimulates proliferation and activation of human circulating monocytes. Cell Immunol. 1999 May 25;194(1):6-11. doi: 10.1006/cimm.1999.1490.
- BackgroundSpertus, J., Kansas City Cardiomyopathy Questionnaire MDDT decision summary. <fda.gov>
- BackgroundThomas, R, Cohn, J., Minnesota Living with Heart Failure Questionnaire <license.umn.edu/product/minnesota-living-with-heart-fialure-questionnaire-mlhfq>
- Individual participant dataSharing planned: Yes
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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.
Michael E 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 Lactobacillus Plantarum 299v Freeze Dried Capsule and Freeze Dried Potato Starch Capsule in people with Heart Failure and Heart Failure With Reduced Ejection Fraction, 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 5 inclusion and 17 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 1 May 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?
Maximal Oxygen Consumption (VO2Max) (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 NCT05752760, 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 1 May 2026.