Nutrition, HealthyNCT05795946
Standard Process Heart and Gut Health Study
A study testing Whole food-based B and D vitamins in people with Nutrition, Healthy, run by Standard Process Inc. at 1 site in United States.
Trial summary
Standard Process Heart and Gut Health Study Read more about this study
- Who is it for?
- Ages 25 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- Whole food-based B and D vitamins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2023to 31 Dec 2024
- 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 25 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy participants (both male and female) aged 25-80 years with omnivorous diet (regular consumption of eggs, red meat, dairy)
- No pre or probiotic consumption during study, no antibiotics during study
- Moderate to high serum levels of TMAO (more than or equal to 4 uM) determined by a standard blood test
- If the participant is on antibiotics, they should finish their medication and wait one month before testing for TMAO as a screening criterion
- Normal blood pressure, non-smokers
- Normal cholesterol
Show all 9Show fewer
- Participants can communicate and follow instructions
- Participants voluntarily signed and dated an informed consent (ICF), reviewed by an Institutional Review Board (IRB), and provided authorization prior to any participation in the study
- Participants who are willing to take nutritional supplements and have no known food allergies
Who cannot join
- Vegan and vegetarian participants
- Participants on medically prescribed diet
- Participants not willing to stop consumption of fermented products (plain yogurt, kefir, kombucha, water kefir, miso, pickled vegetables, and sauerkraut) 2 weeks prior to the study start date and during the study timeline as this will interfere with gut microbiome related outcome assessment
- Participants not willing to stop consuming polyphenols- green tea, cocoa, flaxseed, berries, and energy drinks
- Participants who are currently or have participated in other interventional clinical trials in the last 4 weeks
- Participants on certain supplements like GI health related (Probiotics, prebiotics, and/or antimicrobial botanicals), vitamin C, Choline, lecithin or L-carnitine, fish oil/krill oil containing supplements who don't wish to stop supplementation prior to 2 weeks of study start date
Show all 17Show fewer
- Participants who have any confirmed or suspected infectious disease (such as tuberculosis, Hepatitis B or C, HIV infection), malignancy, or any other clinically significant medical condition, which in the investigators' opinion, makes him or her not suitable for inclusion in the study*
- Participants who have pacemakers, an implanted cardioverter defibrillator (ICD), or a cardiac resynchronization therapy device
- Participants who have confirmed or suspected pregnancy (self-reported)
- Participant waiting for a heart transplant
- Participants currently hospitalized for acute myocardial infarction
- Participants with a planned revascularization within 30 days of screening
- Participants must not have any allergies to supplement ingredients (see list)
- Participants who have initiated the use of prescription medications (defined as a medication that can be prescribed only by a properly authorized/licensed clinician), and not authorized non-prescription medications (over-the-counter medications), and other nutritional supplements
- Participants who do not comply with all study requirements (including clinical visits)
- Participants with high cholesterol or on lipid lowering medications like statins
- Participants on following medication: NSAIDS, Steroids, Prednisone, Acid Reflux/GERD medicines: Tagamet, Zantac, Pepcid, Prilosec, Prevacid
Trial locations and contacts
1 site in 1 country.
United States1 site
Standard Process Nutrition Innovation Center
Kannapolis, North Carolina, 28081
About this study
Official title: Effects of a Whole Food Based Nutritional Formulation on Trimethylamine N-oxide and Cardiometabolic Endpoints in Healthy Adults.
Standard Process Heart and Gut Health Study
Read the detailed description
This prospective pilot clinical study will screen 45 healthy participants regularly consuming omnivorous diet (full fat dairy, red meat, eggs, fish) and have elevated serum Trimethyl amine N-oxide (TMAO) levels. Trimethylamine N-oxide (TMAO) is a gut microbiota derived dietary metabolite which is emerging as a significant and independent predictor of cardiovascular disease (CVD) risk mainly through inflammation and oxidative stress pathways. Long term consumption of animal products elevates TMAO levels due to its abundance of TMAO precursors: choline and L-carnitine. As diet plays a key role in altering the microbial composition and subsequent TMAO levels, it is important to investigate if whole food based nutritional formulations can provide the necessary support required to manage TMAO levels and hence, positively impact cardiometabolic endpoints. Towards this end both B and D vitamins have been shown to influence the levels of circulating TMAO while maintaining a healthy gut microenvironment.
This pilot study aims to explore the modulation of TMAO response in healthy adults after supplementation with a whole food matrix-based B vitamins formulation alone, and in combination with vitamin D. The assessments will be compared to the diet only control group.
- Conditions
- Nutrition, Healthy
- Being tested
- Whole food-based B and D vitamins
- Keywords
- Heart health, B Vitamins, D Vitamins, TMAO, Quality of Life, Healthy Heart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole food-based B and D vitaminsDietary supplement
Looking at whole food-based B and D vitamins to reduce TMAO levels and if this can modulate gut diversity
| Study group | Role | What they receive |
|---|---|---|
| Diet Only Group | No intervention | Diet only: guided diet |
| Combination Group | Experimental | Combination of whole food-based B and D vitamins Receives: Dietary Supplement: Whole food-based B and D vitamins |
| B Only Group | Experimental | Whole food-based B vitamins Receives: Dietary Supplement: Whole food-based B and D vitamins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary
One outcome is to determine if a combination of whole food-based B-vitamins can modulate gut diversity and TMAO response
Measured: 8 weeks
Secondary outcomes (1)
Secondary
Another outcome is to explore the beneficial interplay between B and D vitamin supplementation in reducing TMAO levels through modulation of gut microbiome.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start15 Apr 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Why it stopped: Internal changes and unanticipated challenges with recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Nutrition, HealthyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 groups: 1 for B vitamins only, 1 with B vitamins in addition of D vitamins, and one is diet only. This pilot study aims to explore the modulation of TMAO response in healthy adults after supplementation with a whole food matrix-based B vitamins formulation alone, and in combination with vitamin D. The assessments will be compared to the diet only control group.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Standard Process Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chinmayee Panda, PhD, Principal investigator, Standard Process Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795946
- Sponsor's protocol ID
- SP0012
- Status last verified
- Feb 2025
- First submitted
- 8 Mar 2023
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share data with other researchers
Publications
Li XS, Obeid S, Klingenberg R, Gencer B, Mach F, Raber L, Windecker S, Rodondi N, Nanchen D, Muller O, Miranda MX, Matter CM, Wu Y, Li L, Wang Z, Alamri HS, Gogonea V, Chung YM, Tang WH, Hazen SL, Luscher TF. Gut microbiota-dependent trimethylamine N-oxide in acute coronary syndromes: a prognostic marker for incident cardiovascular events beyond traditional risk factors. Eur Heart J. 2017 Mar 14;38(11):814-824. doi: 10.1093/eurheartj/ehw582.
PubMed 28077467Ma J, Li H. The Role of Gut Microbiota in Atherosclerosis and Hypertension. Front Pharmacol. 2018 Sep 25;9:1082. doi: 10.3389/fphar.2018.01082. eCollection 2018.
PubMed 30319417Brunt VE, Gioscia-Ryan RA, Richey JJ, Zigler MC, Cuevas LM, Gonzalez A, Vazquez-Baeza Y, Battson ML, Smithson AT, Gilley AD, Ackermann G, Neilson AP, Weir T, Davy KP, Knight R, Seals DR. Suppression of the gut microbiome ameliorates age-related arterial dysfunction and oxidative stress in mice. J Physiol. 2019 May;597(9):2361-2378. doi: 10.1113/JP277336. Epub 2019 Feb 27.
PubMed 30714619Sun X, Jiao X, Ma Y, Liu Y, Zhang L, He Y, Chen Y. Trimethylamine N-oxide induces inflammation and endothelial dysfunction in human umbilical vein endothelial cells via activating ROS-TXNIP-NLRP3 inflammasome. Biochem Biophys Res Commun. 2016 Dec 2;481(1-2):63-70. doi: 10.1016/j.bbrc.2016.11.017. Epub 2016 Nov 8.
PubMed 27833015Zhu W, Wang Z, Tang WHW, Hazen SL. Gut Microbe-Generated Trimethylamine N-Oxide From Dietary Choline Is Prothrombotic in Subjects. Circulation. 2017 Apr 25;135(17):1671-1673. doi: 10.1161/CIRCULATIONAHA.116.025338. No abstract available.
PubMed 28438808Li D, Lu Y, Yuan S, Cai X, He Y, Chen J, Wu Q, He D, Fang A, Bo Y, Song P, Bogaert D, Tsilidis K, Larsson SC, Yu H, Zhu H, Theodoratou E, Zhu Y, Li X. Gut microbiota-derived metabolite trimethylamine-N-oxide and multiple health outcomes: an umbrella review and updated meta-analysis. Am J Clin Nutr. 2022 Jul 6;116(1):230-243. doi: 10.1093/ajcn/nqac074.
PubMed 35348578Sohouli MH, Ozovanu OD, Fatahi S, Hekmatdoost A. Impact of probiotic supplementation on trimethylamine N-oxide (TMAO) in humans: A systematic review and meta-analysis of randomized controlled trials. Clin Nutr ESPEN. 2022 Aug;50:56-62. doi: 10.1016/j.clnesp.2022.06.006. Epub 2022 Jun 17.
PubMed 35871952Wang Q, Guo M, Liu Y, Xu M, Shi L, Li X, Zhao J, Zhang H, Wang G, Chen W. Bifidobacterium breve and Bifidobacterium longum Attenuate Choline-Induced Plasma Trimethylamine N-Oxide Production by Modulating Gut Microbiota in Mice. Nutrients. 2022 Mar 14;14(6):1222. doi: 10.3390/nu14061222.
PubMed 35334879Dalla Via A, Gargari G, Taverniti V, Rondini G, Velardi I, Gambaro V, Visconti GL, De Vitis V, Gardana C, Ragg E, Pinto A, Riso P, Guglielmetti S. Urinary TMAO Levels Are Associated with the Taxonomic Composition of the Gut Microbiota and with the Choline TMA-Lyase Gene (cutC) Harbored by Enterobacteriaceae. Nutrients. 2019 Dec 25;12(1):62. doi: 10.3390/nu12010062.
PubMed 31881690Keith ME, Walsh NA, Darling PB, Hanninen SA, Thirugnanam S, Leong-Poi H, Barr A, Sole MJ. B-vitamin deficiency in hospitalized patients with heart failure. J Am Diet Assoc. 2009 Aug;109(8):1406-10. doi: 10.1016/j.jada.2009.05.011.
PubMed 19631047Zhao LG, Shu XO, Li HL, Gao J, Han LH, Wang J, Fang J, Gao YT, Zheng W, Xiang YB. Prospective cohort studies of dietary vitamin B6 intake and risk of cause-specific mortality. Clin Nutr. 2019 Jun;38(3):1180-1187. doi: 10.1016/j.clnu.2018.04.016. Epub 2018 May 4.
PubMed 29764693Reay JL, Smith MA, Riby LM. B vitamins and cognitive performance in older adults: review. ISRN Nutr. 2013 Mar 11;2013:650983. doi: 10.5402/2013/650983. eCollection 2013.
PubMed 24959550Malik M, Hnatkova K, Batchvarov V, Gang Y, Smetana P, Camm AJ. Sample size, power calculations, and their implications for the cost of thorough studies of drug induced QT interval prolongation. Pacing Clin Electrophysiol. 2004 Dec;27(12):1659-69. doi: 10.1111/j.1540-8159.2004.00701.x.
PubMed 15613131Hsiao PY, Mitchell DC, Coffman DL, Allman RM, Locher JL, Sawyer P, Jensen GL, Hartman TJ. Dietary patterns and diet quality among diverse older adults: the University of Alabama at Birmingham Study of Aging. J Nutr Health Aging. 2013 Jan;17(1):19-25. doi: 10.1007/s12603-012-0082-4.
PubMed 23299373Borel P, Mekki N, Boirie Y, Partier A, Alexandre-Gouabau MC, Grolier P, Beaufrere B, Portugal H, Lairon D, Azais-Braesco V. Comparison of the postprandial plasma vitamin A response in young and older adults. J Gerontol A Biol Sci Med Sci. 1998 Mar;53(2):B133-40. doi: 10.1093/gerona/53a.2.b133.
PubMed 9520909
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Whole Food Based Nutritional Formulation on Trimethylamine N-oxide and Cardiometabolic Endpoints in Healthy Adults.
- ClinicalTrials.gov ID
- NCT05795946
- Acronym / sponsor ID
- SP0012
- Conditions
- Nutrition, Healthy
- Keywords
- Heart health, B Vitamins, D Vitamins, TMAO, Quality of Life, Healthy Heart
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Internal changes and unanticipated challenges with recruitment.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Standard Process Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 3 Apr 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.
Standard Process Heart and Gut Health Study
Detailed description
This prospective pilot clinical study will screen 45 healthy participants regularly consuming omnivorous diet (full fat dairy, red meat, eggs, fish) and have elevated serum Trimethyl amine N-oxide (TMAO) levels. Trimethylamine N-oxide (TMAO) is a gut microbiota derived dietary metabolite which is emerging as a significant and independent predictor of cardiovascular disease (CVD) risk mainly through inflammation and oxidative stress pathways. Long term consumption of animal products elevates TMAO levels due to its abundance of TMAO precursors: choline and L-carnitine. As diet plays a key role in altering the microbial composition and subsequent TMAO levels, it is important to investigate if whole food based nutritional formulations can provide the necessary support required to manage TMAO levels and hence, positively impact cardiometabolic endpoints. Towards this end both B and D vitamins have been shown to influence the levels of circulating TMAO while maintaining a healthy gut microenvironment.
This pilot study aims to explore the modulation of TMAO response in healthy adults after supplementation with a whole food matrix-based B vitamins formulation alone, and in combination with vitamin D. The assessments will be compared to the diet only control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- 3 groups: 1 for B vitamins only, 1 with B vitamins in addition of D vitamins, and one is diet only. This pilot study aims to explore the modulation of TMAO response in healthy adults after supplementation with a whole food matrix-based B vitamins formulation alone, and in combination with vitamin D. The assessments will be compared to the diet only control group.
| Arm | Type | Receives |
|---|---|---|
| Diet Only Group | No intervention | –Diet only: guided diet |
| Combination Group | Experimental | Dietary Supplement: Whole food-based B and D vitaminsCombination of whole food-based B and D vitamins |
| B Only Group | Experimental | Dietary Supplement: Whole food-based B and D vitaminsWhole food-based B vitamins |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy participants (both male and female) aged 25-80 years with omnivorous diet (regular consumption of eggs, red meat, dairy)
- No pre or probiotic consumption during study, no antibiotics during study
- Moderate to high serum levels of TMAO (more than or equal to 4 uM) determined by a standard blood test
- If the participant is on antibiotics, they should finish their medication and wait one month before testing for TMAO as a screening criterion
- Normal blood pressure, non-smokers
Key exclusion criteria (17 listed)
- Vegan and vegetarian participants
- Participants on medically prescribed diet
- Participants not willing to stop consumption of fermented products (plain yogurt, kefir, kombucha, water kefir, miso, pickled vegetables, and sauerkraut) 2 weeks prior to the study start date and during the study timeline as this will interfere with gut microbiome related outcome assessment
- Participants not willing to stop consuming polyphenols- green tea, cocoa, flaxseed, berries, and energy drinks
- Participants who are currently or have participated in other interventional clinical trials in the last 4 weeks
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 |
|---|---|---|
| Whole food-based B and D vitaminsLooking at whole food-based B and D vitamins to reduce TMAO levels and if this can modulate gut diversity | Dietary supplement | B Only Group, Combination Group |
Primary outcome
Primary
Time frame: 8 weeks
One outcome is to determine if a combination of whole food-based B-vitamins can modulate gut diversity and TMAO response
1 secondary outcome
Secondary
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Internal changes and unanticipated challenges with recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Background: PubMed 28077467Li XS, Obeid S, Klingenberg R, Gencer B, Mach F, Raber L, Windecker S, Rodondi N, Nanchen D, Muller O, Miranda MX, Matter CM, Wu Y, Li L, Wang Z, Alamri HS, Gogonea V, Chung YM, Tang WH, Hazen SL, Luscher TF. Gut microbiota-dependent trimethylamine N-oxide in acute coronary syndromes: a prognostic marker for incident cardiovascular events beyond traditional risk factors. Eur Heart J. 2017 Mar 14;38(11):814-824. doi: 10.1093/eurheartj/ehw582.
- Background: PubMed 30319417Ma J, Li H. The Role of Gut Microbiota in Atherosclerosis and Hypertension. Front Pharmacol. 2018 Sep 25;9:1082. doi: 10.3389/fphar.2018.01082. eCollection 2018.
- Background: PubMed 30714619Brunt VE, Gioscia-Ryan RA, Richey JJ, Zigler MC, Cuevas LM, Gonzalez A, Vazquez-Baeza Y, Battson ML, Smithson AT, Gilley AD, Ackermann G, Neilson AP, Weir T, Davy KP, Knight R, Seals DR. Suppression of the gut microbiome ameliorates age-related arterial dysfunction and oxidative stress in mice. J Physiol. 2019 May;597(9):2361-2378. doi: 10.1113/JP277336. Epub 2019 Feb 27.
- Background: PubMed 27833015Sun X, Jiao X, Ma Y, Liu Y, Zhang L, He Y, Chen Y. Trimethylamine N-oxide induces inflammation and endothelial dysfunction in human umbilical vein endothelial cells via activating ROS-TXNIP-NLRP3 inflammasome. Biochem Biophys Res Commun. 2016 Dec 2;481(1-2):63-70. doi: 10.1016/j.bbrc.2016.11.017. Epub 2016 Nov 8.
- Background: PubMed 28438808Zhu W, Wang Z, Tang WHW, Hazen SL. Gut Microbe-Generated Trimethylamine N-Oxide From Dietary Choline Is Prothrombotic in Subjects. Circulation. 2017 Apr 25;135(17):1671-1673. doi: 10.1161/CIRCULATIONAHA.116.025338. No abstract available.
- Background: PubMed 35348578Li D, Lu Y, Yuan S, Cai X, He Y, Chen J, Wu Q, He D, Fang A, Bo Y, Song P, Bogaert D, Tsilidis K, Larsson SC, Yu H, Zhu H, Theodoratou E, Zhu Y, Li X. Gut microbiota-derived metabolite trimethylamine-N-oxide and multiple health outcomes: an umbrella review and updated meta-analysis. Am J Clin Nutr. 2022 Jul 6;116(1):230-243. doi: 10.1093/ajcn/nqac074.
- Background: PubMed 35871952Sohouli MH, Ozovanu OD, Fatahi S, Hekmatdoost A. Impact of probiotic supplementation on trimethylamine N-oxide (TMAO) in humans: A systematic review and meta-analysis of randomized controlled trials. Clin Nutr ESPEN. 2022 Aug;50:56-62. doi: 10.1016/j.clnesp.2022.06.006. Epub 2022 Jun 17.
- Background: PubMed 35334879Wang Q, Guo M, Liu Y, Xu M, Shi L, Li X, Zhao J, Zhang H, Wang G, Chen W. Bifidobacterium breve and Bifidobacterium longum Attenuate Choline-Induced Plasma Trimethylamine N-Oxide Production by Modulating Gut Microbiota in Mice. Nutrients. 2022 Mar 14;14(6):1222. doi: 10.3390/nu14061222.
- Background: PubMed 31881690Dalla Via A, Gargari G, Taverniti V, Rondini G, Velardi I, Gambaro V, Visconti GL, De Vitis V, Gardana C, Ragg E, Pinto A, Riso P, Guglielmetti S. Urinary TMAO Levels Are Associated with the Taxonomic Composition of the Gut Microbiota and with the Choline TMA-Lyase Gene (cutC) Harbored by Enterobacteriaceae. Nutrients. 2019 Dec 25;12(1):62. doi: 10.3390/nu12010062.
- Background: PubMed 19631047Keith ME, Walsh NA, Darling PB, Hanninen SA, Thirugnanam S, Leong-Poi H, Barr A, Sole MJ. B-vitamin deficiency in hospitalized patients with heart failure. J Am Diet Assoc. 2009 Aug;109(8):1406-10. doi: 10.1016/j.jada.2009.05.011.
- Background: PubMed 29764693Zhao LG, Shu XO, Li HL, Gao J, Han LH, Wang J, Fang J, Gao YT, Zheng W, Xiang YB. Prospective cohort studies of dietary vitamin B6 intake and risk of cause-specific mortality. Clin Nutr. 2019 Jun;38(3):1180-1187. doi: 10.1016/j.clnu.2018.04.016. Epub 2018 May 4.
- Background: PubMed 24959550Reay JL, Smith MA, Riby LM. B vitamins and cognitive performance in older adults: review. ISRN Nutr. 2013 Mar 11;2013:650983. doi: 10.5402/2013/650983. eCollection 2013.
- Individual participant dataSharing planned: No. We do not plan to share data with other researchers
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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.
Chinmayee Panda, PhD principal investigator
Standard Process Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole food-based B and D vitamins in people with Nutrition, Healthy, run by Standard Process Inc. 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 9 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: stopped early, as of the sponsor's last update on 10 Feb 2025. 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. 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 was stopped early (reason given: Internal changes and unanticipated challenges with recruitment.). Results are not available in the source record.
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?
Primary (time frame: 8 weeks). 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 NCT05795946, which also lists 41 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 10 Feb 2025.