Chronic Kidney DiseaseNCT05504850
Multicultural Healthy Diet in Chronic Kidney Disease
A study testing Multicultural Health Diet in people with Chronic Kidney Disease, run by Montefiore Medical Center at 1 site in United States.
Trial summary
This is a pilot intervention study to evaluate the feasibility and acceptability of a culturally-tailored anti-inflammatory diet intervention in participants with chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Multicultural Health Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- CKD stage 3 (estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73m^2 to < 60 ml/min/1.73m^2)
- Residency in the Bronx
- Sufficient hearing, vision, and proficiency in English or Spanish to comprehend dietary counseling and low-level printed educational materials
- Provide written informed consent
Who cannot join
- History of hyperkalemia, or baseline serum potassium (K) > 4.8
- CKD stage 4 or higher estimated Glomerular Filtration Rate (eGFR) <30 ml/min/1.73 m^2
- Unwillingness/inability to make dietary changes or if primarily interested in weight loss as judged by discussion with the participant
- History of kidney transplant
- Poorly controlled diabetes (HbA1c >9%) or insulin use
- Any severe chronic illness, low literacy, or other serious condition that precludes making dietary changes and requires strict dietary restrictions or completion of study activities
- Plans to relocate out of New York City in the next 2 months
- Visual, auditory, or motor impairment that precludes completion of the assessments
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10461
About this study
Official title: The Feasibility and Acceptability of a Multicultural Healthy Diet (Anti-inflammatory Dietary Pattern) in Racial/Ethnic Minorities With Chronic Kidney Disease
This is a pilot intervention study to evaluate the feasibility and acceptability of a culturally-tailored anti-inflammatory diet intervention in participants with chronic kidney disease.
Read the detailed description
This is a pilot pre-post comparison intervention study to evaluate the feasibility and acceptability of a culturally-tailored anti-inflammatory diet intervention. The study will recruit approximately 20 adult participants with chronic kidney disease (CKD) from nephrology clinics in the Bronx. The diet emphasizes limiting animal and high saturated fat foods with focus on anti-inflammatory foods/food components specific to the cultural context of the participant. The diet will also be tailored to needs of the CKD population including a focus on lowering sodium intake. The intervention will be delivered by an experienced nutritionist with expertise providing dietary counseling to patients with CKD. The investigative team will assess whether the diet is feasible, acceptable, and safe in patients with CKD through dietary intake assessments, questionnaires and serum biomarkers. Information from study will help inform the study design and intervention of a future large-scale, study aimed at improving CKD outcomes. The clinical site for the proposed study is at the Albert Einstein College of Medicine and Montefiore Medical Center.
- Conditions
- Chronic Kidney Disease
- Being tested
- Multicultural Health Diet
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicultural Health DietOther
The food-based components will be similar to the anti-inflammatory diet of the ongoing MHD study (NCT03240406), which emphasizes limiting animal and high saturated fat foods with focus on anti-inflammatory foods/food components specific to the cultural context of the participant. The diet will also be tailored to needs of the CKD population including a focus on lowering sodium intake. The intervention (dietary counseling) will be delivered by experienced kidney disease nutritionist.
| Study group | Role | What they receive |
|---|---|---|
| All participants will receive the intervention | Other | Not described Receives: Other: Multicultural Health Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Dietary Intervention
Feasibility will be assessed using the Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool and the Energy-Adjusted Dietary Inflammatory Index (E-DII®).
The ASA24® is a web-based tool that enables multiple, automatically coded, self-administered 24-hour diet recalls and/or single or multi-day food records (i.e., food diaries).
The Energy Adjusted Dietary Inflammatory Index (E-DII®) quantifies the inflammatory potential of a person's diet while adjusting for total energy intake. Scores range from -8.87 (maximally anti-inflammatory) to +7.98 (maximally pro-inflammatory). Higher (positive) scores indicate greater adherence to a pro-inflammatory dietary pattern (e.g., highly processed or fried foods, sugary beverages) and are associated with poorer health outcomes, whereas lower (negative) scores indicate greater adherence to an anti-inflammatory dietary pattern (e.g., leafy greens, fruits, fish) and are associated with better health outcomes.
Measured: From baseline (pre-intervention) to 2 months (post-intervention)
Acceptability of Dietary Intervention
Acceptability of the dietary intervention will be assessed using the Acceptability of the Multicultural Healthy Diet (MHD) in CKD questionnaire. Participants will be asked to rate acceptability based on five items regarding whether the dietary intervention met their approval; was appealing; whether they liked the diet, in general; liked using herbs/spices that they had not used before; and would recommend the diet to family/friends. Responses to each item are rated on a 5-point ordinal scale: (Completely disagree, Disagree, Neither agree nor disagree, Agree or Completely agree). The number/percentage of participants selecting each category will be tabulated.
Measured: 2 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start3 Nov 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tanya Johns, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504850
- Sponsor's protocol ID
- 2021-12753
- Other IDs
- K23DK124644-01A1
- Status last verified
- Jul 2026
- First submitted
- 15 Aug 2022
- Last updated
- 11 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Migliori M, Panichi V, de la Torre R, Fito M, Covas M, Bertelli A, Munoz-Aguayo D, Scatena A, Paoletti S, Ronco C. Anti-inflammatory effect of white wine in CKD patients and healthy volunteers. Blood Purif. 2015;39(1-3):218-223. doi: 10.1159/000371570. Epub 2015 Mar 31.
PubMed 25833063Nettleton JA, Steffen LM, Mayer-Davis EJ, Jenny NS, Jiang R, Herrington DM, Jacobs DR Jr. Dietary patterns are associated with biochemical markers of inflammation and endothelial activation in the Multi-Ethnic Study of Atherosclerosis (MESA). Am J Clin Nutr. 2006 Jun;83(6):1369-79. doi: 10.1093/ajcn/83.6.1369.
PubMed 16762949Mazidi M, Shivappa N, Wirth MD, Hebert JR, Kengne AP. Greater Dietary Inflammatory Index score is associated with higher likelihood of chronic kidney disease. Br J Nutr. 2018 Jul;120(2):204-209. doi: 10.1017/S0007114518001071.
PubMed 29947319Gupta J, Mitra N, Kanetsky PA, Devaney J, Wing MR, Reilly M, Shah VO, Balakrishnan VS, Guzman NJ, Girndt M, Periera BG, Feldman HI, Kusek JW, Joffe MM, Raj DS; CRIC Study Investigators. Association between albuminuria, kidney function, and inflammatory biomarker profile in CKD in CRIC. Clin J Am Soc Nephrol. 2012 Dec;7(12):1938-46. doi: 10.2215/CJN.03500412. Epub 2012 Sep 27.
PubMed 23024164Amdur RL, Feldman HI, Gupta J, Yang W, Kanetsky P, Shlipak M, Rahman M, Lash JP, Townsend RR, Ojo A, Roy-Chaudhury A, Go AS, Joffe M, He J, Balakrishnan VS, Kimmel PL, Kusek JW, Raj DS; CRIC Study Investigators. Inflammation and Progression of CKD: The CRIC Study. Clin J Am Soc Nephrol. 2016 Sep 7;11(9):1546-1556. doi: 10.2215/CJN.13121215. Epub 2016 Jun 23.
PubMed 27340285Shankar A, Sun L, Klein BE, Lee KE, Muntner P, Nieto FJ, Tsai MY, Cruickshanks KJ, Schubert CR, Brazy PC, Coresh J, Klein R. Markers of inflammation predict the long-term risk of developing chronic kidney disease: a population-based cohort study. Kidney Int. 2011 Dec;80(11):1231-8. doi: 10.1038/ki.2011.283. Epub 2011 Aug 24.
PubMed 21866089Miyamoto T, Carrero JJ, Stenvinkel P. Inflammation as a risk factor and target for therapy in chronic kidney disease. Curr Opin Nephrol Hypertens. 2011 Nov;20(6):662-8. doi: 10.1097/MNH.0b013e32834ad504.
PubMed 21825982Qian Q. Inflammation: A Key Contributor to the Genesis and Progression of Chronic Kidney Disease. Contrib Nephrol. 2017;191:72-83. doi: 10.1159/000479257. Epub 2017 Sep 14.
PubMed 28910792Ruiz S, Pergola PE, Zager RA, Vaziri ND. Targeting the transcription factor Nrf2 to ameliorate oxidative stress and inflammation in chronic kidney disease. Kidney Int. 2013 Jun;83(6):1029-41. doi: 10.1038/ki.2012.439. Epub 2013 Jan 16.
PubMed 23325084Vilaysane A, Chun J, Seamone ME, Wang W, Chin R, Hirota S, Li Y, Clark SA, Tschopp J, Trpkov K, Hemmelgarn BR, Beck PL, Muruve DA. The NLRP3 inflammasome promotes renal inflammation and contributes to CKD. J Am Soc Nephrol. 2010 Oct;21(10):1732-44. doi: 10.1681/ASN.2010020143. Epub 2010 Aug 5.
PubMed 20688930Christ A, Gunther P, Lauterbach MAR, Duewell P, Biswas D, Pelka K, Scholz CJ, Oosting M, Haendler K, Bassler K, Klee K, Schulte-Schrepping J, Ulas T, Moorlag SJCFM, Kumar V, Park MH, Joosten LAB, Groh LA, Riksen NP, Espevik T, Schlitzer A, Li Y, Fitzgerald ML, Netea MG, Schultze JL, Latz E. Western Diet Triggers NLRP3-Dependent Innate Immune Reprogramming. Cell. 2018 Jan 11;172(1-2):162-175.e14. doi: 10.1016/j.cell.2017.12.013.
PubMed 29328911Baer DJ, Judd JT, Clevidence BA, Tracy RP. Dietary fatty acids affect plasma markers of inflammation in healthy men fed controlled diets: a randomized crossover study. Am J Clin Nutr. 2004 Jun;79(6):969-73. doi: 10.1093/ajcn/79.6.969.
PubMed 15159225Lopez-Garcia E, Schulze MB, Meigs JB, Manson JE, Rifai N, Stampfer MJ, Willett WC, Hu FB. Consumption of trans fatty acids is related to plasma biomarkers of inflammation and endothelial dysfunction. J Nutr. 2005 Mar;135(3):562-6. doi: 10.1093/jn/135.3.562.
PubMed 15735094Lin J, Hu FB, Curhan GC. Associations of diet with albuminuria and kidney function decline. Clin J Am Soc Nephrol. 2010 May;5(5):836-43. doi: 10.2215/CJN.08001109. Epub 2010 Mar 18.
PubMed 20299364Odermatt A. The Western-style diet: a major risk factor for impaired kidney function and chronic kidney disease. Am J Physiol Renal Physiol. 2011 Nov;301(5):F919-31. doi: 10.1152/ajprenal.00068.2011. Epub 2011 Aug 31.
PubMed 21880837
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Acceptability of a Multicultural Healthy Diet (Anti-inflammatory Dietary Pattern) in Racial/Ethnic Minorities With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05504850
- Acronym / sponsor ID
- 2021-12753
- Conditions
- Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Posted 11 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot intervention study to evaluate the feasibility and acceptability of a culturally-tailored anti-inflammatory diet intervention in participants with chronic kidney disease.
Detailed description
This is a pilot pre-post comparison intervention study to evaluate the feasibility and acceptability of a culturally-tailored anti-inflammatory diet intervention. The study will recruit approximately 20 adult participants with chronic kidney disease (CKD) from nephrology clinics in the Bronx. The diet emphasizes limiting animal and high saturated fat foods with focus on anti-inflammatory foods/food components specific to the cultural context of the participant. The diet will also be tailored to needs of the CKD population including a focus on lowering sodium intake. The intervention will be delivered by an experienced nutritionist with expertise providing dietary counseling to patients with CKD. The investigative team will assess whether the diet is feasible, acceptable, and safe in patients with CKD through dietary intake assessments, questionnaires and serum biomarkers. Information from study will help inform the study design and intervention of a future large-scale, study aimed at improving CKD outcomes. The clinical site for the proposed study is at the Albert Einstein College of Medicine and Montefiore Medical Center.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants will receive the intervention | Other | Other: Multicultural Health Diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- CKD stage 3 (estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73m^2 to < 60 ml/min/1.73m^2)
- Residency in the Bronx
- Sufficient hearing, vision, and proficiency in English or Spanish to comprehend dietary counseling and low-level printed educational materials
- Provide written informed consent
Key exclusion criteria (8 listed)
- History of hyperkalemia, or baseline serum potassium (K) > 4.8
- CKD stage 4 or higher estimated Glomerular Filtration Rate (eGFR) <30 ml/min/1.73 m^2
- Unwillingness/inability to make dietary changes or if primarily interested in weight loss as judged by discussion with the participant
- History of kidney transplant
- Poorly controlled diabetes (HbA1c >9%) or insulin use
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 |
|---|---|---|
| Multicultural Health DietThe food-based components will be similar to the anti-inflammatory diet of the ongoing MHD study (NCT03240406), which emphasizes limiting animal and high saturated fat foods with focus on anti-inflammatory foods/food components specific to the cultural context of the participant. The diet will also be tailored to needs of the CKD population including a focus on lowering sodium intake. The intervention (dietary counseling) will be delivered by experienced kidney disease nutritionist. | Other | All participants will receive the intervention |
Primary outcome
Feasibility of Dietary Intervention
Time frame: From baseline (pre-intervention) to 2 months (post-intervention)
Feasibility will be assessed using the Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool and the Energy-Adjusted Dietary Inflammatory Index (E-DII®). The ASA24® is a web-based tool that enables multiple, automatically coded, self-administered 24-hour diet recalls and/or single or multi-day food records (i.e., food diaries). The Energy Adjusted Dietary Inflammatory Index (E-DII®) quantifies the inflammatory potential of a person's diet while adjusting for total energy intake. Scores range from -8.87 (maximally anti-inflammatory) to +7.98 (maximally pro-inflammatory). Higher (positive) scores indicate greater adherence to a pro-inflammatory dietary pattern (e.g., highly processed or fried foods, sugary beverages) and are associated with poorer health outcomes, whereas lower (negative) scores indicate greater adherence to an anti-inflammatory dietary pattern (e.g., leafy greens, fruits, fish) and are associated with better health outcomes.
Acceptability of Dietary Intervention
Time frame: 2 months post baseline
Acceptability of the dietary intervention will be assessed using the Acceptability of the Multicultural Healthy Diet (MHD) in CKD questionnaire. Participants will be asked to rate acceptability based on five items regarding whether the dietary intervention met their approval; was appealing; whether they liked the diet, in general; liked using herbs/spices that they had not used before; and would recommend the diet to family/friends. Responses to each item are rated on a 5-point ordinal scale: (Completely disagree, Disagree, Neither agree nor disagree, Agree or Completely agree). The number/percentage of participants selecting each category will be tabulated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25833063Migliori M, Panichi V, de la Torre R, Fito M, Covas M, Bertelli A, Munoz-Aguayo D, Scatena A, Paoletti S, Ronco C. Anti-inflammatory effect of white wine in CKD patients and healthy volunteers. Blood Purif. 2015;39(1-3):218-223. doi: 10.1159/000371570. Epub 2015 Mar 31.
- Background: PubMed 16762949Nettleton JA, Steffen LM, Mayer-Davis EJ, Jenny NS, Jiang R, Herrington DM, Jacobs DR Jr. Dietary patterns are associated with biochemical markers of inflammation and endothelial activation in the Multi-Ethnic Study of Atherosclerosis (MESA). Am J Clin Nutr. 2006 Jun;83(6):1369-79. doi: 10.1093/ajcn/83.6.1369.
- Background: PubMed 29947319Mazidi M, Shivappa N, Wirth MD, Hebert JR, Kengne AP. Greater Dietary Inflammatory Index score is associated with higher likelihood of chronic kidney disease. Br J Nutr. 2018 Jul;120(2):204-209. doi: 10.1017/S0007114518001071.
- Background: PubMed 23024164Gupta J, Mitra N, Kanetsky PA, Devaney J, Wing MR, Reilly M, Shah VO, Balakrishnan VS, Guzman NJ, Girndt M, Periera BG, Feldman HI, Kusek JW, Joffe MM, Raj DS; CRIC Study Investigators. Association between albuminuria, kidney function, and inflammatory biomarker profile in CKD in CRIC. Clin J Am Soc Nephrol. 2012 Dec;7(12):1938-46. doi: 10.2215/CJN.03500412. Epub 2012 Sep 27.
- Background: PubMed 27340285Amdur RL, Feldman HI, Gupta J, Yang W, Kanetsky P, Shlipak M, Rahman M, Lash JP, Townsend RR, Ojo A, Roy-Chaudhury A, Go AS, Joffe M, He J, Balakrishnan VS, Kimmel PL, Kusek JW, Raj DS; CRIC Study Investigators. Inflammation and Progression of CKD: The CRIC Study. Clin J Am Soc Nephrol. 2016 Sep 7;11(9):1546-1556. doi: 10.2215/CJN.13121215. Epub 2016 Jun 23.
- Background: PubMed 21866089Shankar A, Sun L, Klein BE, Lee KE, Muntner P, Nieto FJ, Tsai MY, Cruickshanks KJ, Schubert CR, Brazy PC, Coresh J, Klein R. Markers of inflammation predict the long-term risk of developing chronic kidney disease: a population-based cohort study. Kidney Int. 2011 Dec;80(11):1231-8. doi: 10.1038/ki.2011.283. Epub 2011 Aug 24.
- Background: PubMed 21825982Miyamoto T, Carrero JJ, Stenvinkel P. Inflammation as a risk factor and target for therapy in chronic kidney disease. Curr Opin Nephrol Hypertens. 2011 Nov;20(6):662-8. doi: 10.1097/MNH.0b013e32834ad504.
- Background: PubMed 28910792Qian Q. Inflammation: A Key Contributor to the Genesis and Progression of Chronic Kidney Disease. Contrib Nephrol. 2017;191:72-83. doi: 10.1159/000479257. Epub 2017 Sep 14.
- Background: PubMed 23325084Ruiz S, Pergola PE, Zager RA, Vaziri ND. Targeting the transcription factor Nrf2 to ameliorate oxidative stress and inflammation in chronic kidney disease. Kidney Int. 2013 Jun;83(6):1029-41. doi: 10.1038/ki.2012.439. Epub 2013 Jan 16.
- Background: PubMed 20688930Vilaysane A, Chun J, Seamone ME, Wang W, Chin R, Hirota S, Li Y, Clark SA, Tschopp J, Trpkov K, Hemmelgarn BR, Beck PL, Muruve DA. The NLRP3 inflammasome promotes renal inflammation and contributes to CKD. J Am Soc Nephrol. 2010 Oct;21(10):1732-44. doi: 10.1681/ASN.2010020143. Epub 2010 Aug 5.
- Background: PubMed 29328911Christ A, Gunther P, Lauterbach MAR, Duewell P, Biswas D, Pelka K, Scholz CJ, Oosting M, Haendler K, Bassler K, Klee K, Schulte-Schrepping J, Ulas T, Moorlag SJCFM, Kumar V, Park MH, Joosten LAB, Groh LA, Riksen NP, Espevik T, Schlitzer A, Li Y, Fitzgerald ML, Netea MG, Schultze JL, Latz E. Western Diet Triggers NLRP3-Dependent Innate Immune Reprogramming. Cell. 2018 Jan 11;172(1-2):162-175.e14. doi: 10.1016/j.cell.2017.12.013.
- Background: PubMed 15159225Baer DJ, Judd JT, Clevidence BA, Tracy RP. Dietary fatty acids affect plasma markers of inflammation in healthy men fed controlled diets: a randomized crossover study. Am J Clin Nutr. 2004 Jun;79(6):969-73. doi: 10.1093/ajcn/79.6.969.
- Individual participant dataSharing planned: Undecided
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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.
Tanya Johns, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicultural Health Diet in people with Chronic Kidney Disease, run by Montefiore Medical Center 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 8 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 11 Aug 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. 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?
Yes. Results are posted in the registry (first posted 11 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility of Dietary Intervention (time frame: From baseline (pre-intervention) to 2 months (post-intervention)). The study lists 2 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 NCT05504850, which also lists 37 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 11 Aug 2026.