Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-02-23 @ 4:31 AM
Study NCT ID:
NCT05504850
Status:
COMPLETED
Last Update Posted:
2025-01-31
First Post:
2022-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicultural Healthy Diet in Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-29', 'studyFirstSubmitDate': '2022-08-15', 'studyFirstSubmitQcDate': '2022-08-15', 'lastUpdatePostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Potassium level', 'timeFrame': '2 weeks after first session with nutritionist', 'description': 'A serum potassium will be assessed 2 weeks after starting the diet as an added safety measure.'}], 'primaryOutcomes': [{'measure': 'Feasibility of dietary intervention', 'timeFrame': '2 months post baseline', 'description': 'Change in dietary inflammatory score (Dietary intake will be scored using a dietary inflammation index). The scores at baseline (pre-intervention) will be compared to scores at 2 months. A lower score indicates a more anti-inflammatory dietary pattern. The intervention will be considered feasibile if ≥65% participants have a 2-point or more reduction from their baseline dietary inflammation score.'}, {'measure': 'Acceptability', 'timeFrame': '2 months post baseline', 'description': 'This will be assessed using questionnaires and structured interviews about the dietary intervention'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '25833063', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16762949', 'type': 'BACKGROUND', 'citation': 'Nettleton 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.'}, {'pmid': '29947319', 'type': 'BACKGROUND', 'citation': 'Mazidi 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.'}, {'pmid': '23024164', 'type': 'BACKGROUND', 'citation': 'Gupta 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.'}, {'pmid': '27340285', 'type': 'BACKGROUND', 'citation': 'Amdur 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.'}, {'pmid': '21866089', 'type': 'BACKGROUND', 'citation': 'Shankar 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.'}, {'pmid': '21825982', 'type': 'BACKGROUND', 'citation': 'Miyamoto 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.'}, {'pmid': '28910792', 'type': 'BACKGROUND', 'citation': 'Qian 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* CKD stage 3 (estimated glomerular filtration rate (GFR) \\< 60 - \\>30 ml/min/1.73m2)\n* Residency in the Bronx\n* English or Spanish speaking\n* Provide written informed consent\n\nExclusion Criteria:\n\n* History of hyperkalemia, or baseline serum potassium (K) \\> 4.8\n* CKD stage 4 or higher (eGFR \\<30 ml/min/1.73 m\\^2)\n* Unwillingness to make dietary changes\n* History of kidney transplant\n* Poorly controlled diabetes (HbA1c \\>9%) or insulin use\n* Any severe chronic illness, low literacy, or other condition that precludes making dietary changes or completion of study activities'}, 'identificationModule': {'nctId': 'NCT05504850', 'briefTitle': 'Multicultural Healthy Diet in Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'The Feasibility and Acceptability of a Multicultural Healthy Diet (Anti-inflammatory Dietary Pattern) in Racial/Ethnic Minorities With Chronic Kidney Disease', 'orgStudyIdInfo': {'id': '2021-12753'}, 'secondaryIdInfos': [{'id': 'K23DK124644-01A1', 'link': 'https://reporter.nih.gov/quickSearch/K23DK124644-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'All participants will receive the intervention', 'interventionNames': ['Other: Multicultural Health Diet']}], 'interventions': [{'name': 'Multicultural Health Diet', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['All participants will receive the intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Tanya Johns, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}