- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05504850
만성콩팥병 환자의 다문화 건강식
만성콩팥병을 앓고 있는 소수인종/민족의 다문화 건강식(항염증 식이패턴)의 타당성 및 수용성 원문보기 KCI 원문보기 인용
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New York
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The Bronx, New York, 미국, 10461
- Montefiore Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
- 연령 ≥18세
- CKD 3기(추정 사구체 여과율(GFR) < 60 - >30 ml/min/1.73m2)
- 브롱크스 거주
- 영어 또는 스페인어 말하기
- 서면 동의서 제공
제외 기준:
- 고칼륨혈증 병력 또는 기준선 혈청 K > 4.6
- CKD 4기 이상(eGFR <30 ml/min/1.73 m2)
- 식이 변화를 원하지 않음
- 신장 이식의 역사
- 제대로 조절되지 않는 당뇨병(HbA1c >9%) 또는 인슐린 사용
- 조절되지 않는 고혈압(혈압 >150/90mmHg)
- 중증 만성 질환, 문해력 저하 또는 식습관 변화 또는 학습 활동 완료를 방해하는 기타 상태
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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다른: 모든 참가자는 중재를 받게 됩니다.
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식품 기반 구성 요소는 진행 중인 MHD 연구(NCT03240406)의 항염증 식단과 유사할 것입니다. 이 연구에서는 참가자의 문화적 맥락에 특정한 항염증 식품/식품 구성 요소에 초점을 두고 동물성 및 고포화 지방 식품 제한을 강조합니다. .
식이요법은 또한 나트륨 섭취량 감소에 초점을 맞추는 것을 포함하여 CKD 인구의 요구에 맞춰질 것입니다.
개입(식이 상담)은 경험이 풍부한 신장 질환 영양사가 제공합니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Feasibility of Dietary Intervention
기간: From baseline (pre-intervention) to 2 months (post-intervention)
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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. |
From baseline (pre-intervention) to 2 months (post-intervention)
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Acceptability of Dietary Intervention
기간: 2 months post baseline
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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.
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2 months post baseline
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Potassium Level
기간: 2-4 weeks after first session with nutritionist (onset of intervention)
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A serum potassium will be assessed 2-4 weeks after starting the diet as an added safety measure.
Results are summarized in milliequivalents/liter (mEq/L).
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2-4 weeks after first session with nutritionist (onset of intervention)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Tanya Johns, MD, Montefiore Medical Center
간행물 및 유용한 링크
일반 간행물
- Goraya N, Simoni J, Jo C, Wesson DE. Dietary acid reduction with fruits and vegetables or bicarbonate attenuates kidney injury in patients with a moderately reduced glomerular filtration rate due to hypertensive nephropathy. Kidney Int. 2012 Jan;81(1):86-93. doi: 10.1038/ki.2011.313. Epub 2011 Aug 31.
- Goraya N, Simoni J, Jo CH, Wesson DE. Treatment of metabolic acidosis in patients with stage 3 chronic kidney disease with fruits and vegetables or oral bicarbonate reduces urine angiotensinogen and preserves glomerular filtration rate. Kidney Int. 2014 Nov;86(5):1031-8. doi: 10.1038/ki.2014.83. Epub 2014 Apr 2.
- Ruiz 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.
- Gibson AA, Sainsbury A. Strategies to Improve Adherence to Dietary Weight Loss Interventions in Research and Real-World Settings. Behav Sci (Basel). 2017 Jul 11;7(3):44. doi: 10.3390/bs7030044.
- 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.
- Howard BV, Manson JE, Stefanick ML, Beresford SA, Frank G, Jones B, Rodabough RJ, Snetselaar L, Thomson C, Tinker L, Vitolins M, Prentice R. Low-fat dietary pattern and weight change over 7 years: the Women's Health Initiative Dietary Modification Trial. JAMA. 2006 Jan 4;295(1):39-49. doi: 10.1001/jama.295.1.39.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Vilaysane 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.
- Christ 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.
- Baer 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.
- Lopez-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.
- Lin 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.
- Odermatt 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.
- Lopez-Garcia E, Schulze MB, Fung TT, Meigs JB, Rifai N, Manson JE, Hu FB. Major dietary patterns are related to plasma concentrations of markers of inflammation and endothelial dysfunction. Am J Clin Nutr. 2004 Oct;80(4):1029-35. doi: 10.1093/ajcn/80.4.1029.
- Farhadnejad H, Asghari G, Mirmiran P, Yuzbashian E, Azizi F. Micronutrient Intakes and Incidence of Chronic Kidney Disease in Adults: Tehran Lipid and Glucose Study. Nutrients. 2016 Apr 20;8(4):217. doi: 10.3390/nu8040217.
- Huang X, Jimenez-Moleon JJ, Lindholm B, Cederholm T, Arnlov J, Riserus U, Sjogren P, Carrero JJ. Mediterranean diet, kidney function, and mortality in men with CKD. Clin J Am Soc Nephrol. 2013 Sep;8(9):1548-55. doi: 10.2215/CJN.01780213. Epub 2013 Jun 6.
- Kim H, Caulfield LE, Garcia-Larsen V, Steffen LM, Grams ME, Coresh J, Rebholz CM. Plant-Based Diets and Incident CKD and Kidney Function. Clin J Am Soc Nephrol. 2019 May 7;14(5):682-691. doi: 10.2215/CJN.12391018. Epub 2019 Apr 25.
- Ford ES, Giles WH, Myers GL, Rifai N, Ridker PM, Mannino DM. C-reactive protein concentration distribution among US children and young adults: findings from the National Health and Nutrition Examination Survey, 1999-2000. Clin Chem. 2003 Aug;49(8):1353-7. doi: 10.1373/49.8.1353.
- Lakoski SG, Cushman M, Criqui M, Rundek T, Blumenthal RS, D'Agostino RB Jr, Herrington DM. Gender and C-reactive protein: data from the Multiethnic Study of Atherosclerosis (MESA) cohort. Am Heart J. 2006 Sep;152(3):593-8. doi: 10.1016/j.ahj.2006.02.015.
- Inker LA, Schmid CH, Tighiouart H, Eckfeldt JH, Feldman HI, Greene T, Kusek JW, Manzi J, Van Lente F, Zhang YL, Coresh J, Levey AS; CKD-EPI Investigators. Estimating glomerular filtration rate from serum creatinine and cystatin C. N Engl J Med. 2012 Jul 5;367(1):20-9. doi: 10.1056/NEJMoa1114248.
- Guasch-Ferre M, Hruby A, Salas-Salvado J, Martinez-Gonzalez MA, Sun Q, Willett WC, Hu FB. Olive oil consumption and risk of type 2 diabetes in US women. Am J Clin Nutr. 2015 Aug;102(2):479-86. doi: 10.3945/ajcn.115.112029. Epub 2015 Jul 8.
- Bonaccio M, Bonanni AE, Di Castelnuovo A, De Lucia F, Donati MB, de Gaetano G, Iacoviello L; Moli-sani Project Investigators. Low income is associated with poor adherence to a Mediterranean diet and a higher prevalence of obesity: cross-sectional results from the Moli-sani study. BMJ Open. 2012 Nov 19;2(6):e001685. doi: 10.1136/bmjopen-2012-001685. Print 2012.
- Bonaccio M, Di Castelnuovo A, Pounis G, Costanzo S, Persichillo M, Cerletti C, Donati MB, de Gaetano G, Iacoviello L; Moli-sani Study Investigators. High adherence to the Mediterranean diet is associated with cardiovascular protection in higher but not in lower socioeconomic groups: prospective findings from the Moli-sani study. Int J Epidemiol. 2017 Oct 1;46(5):1478-1487. doi: 10.1093/ije/dyx145.
- Alisha Coleman-Jensen MPR, Christian A. Gregory, and Anita Singh. Household Food Security in the United States in 2017. US Department of Agriculture, Economic Research Service. 2018( ERR-256).
- Bower KM, Thorpe RJ Jr, Rohde C, Gaskin DJ. The intersection of neighborhood racial segregation, poverty, and urbanicity and its impact on food store availability in the United States. Prev Med. 2014 Jan;58:33-9. doi: 10.1016/j.ypmed.2013.10.010. Epub 2013 Oct 23.
- Hager ER, Cockerham A, O'Reilly N, Harrington D, Harding J, Hurley KM, Black MM. Food swamps and food deserts in Baltimore City, MD, USA: associations with dietary behaviours among urban adolescent girls. Public Health Nutr. 2017 Oct;20(14):2598-2607. doi: 10.1017/S1368980016002123. Epub 2016 Sep 22.
- Block JP, Scribner RA, DeSalvo KB. Fast food, race/ethnicity, and income: a geographic analysis. Am J Prev Med. 2004 Oct;27(3):211-7. doi: 10.1016/j.amepre.2004.06.007.
- Sumlin LL, Brown SA. Culture and Food Practices of African American Women With Type 2 Diabetes. Diabetes Educ. 2017 Dec;43(6):565-575. doi: 10.1177/0145721717730646. Epub 2017 Sep 20.
- van Rompay MI, McKeown NM, Castaneda-Sceppa C, Falcon LM, Ordovas JM, Tucker KL. Acculturation and sociocultural influences on dietary intake and health status among Puerto Rican adults in Massachusetts. J Acad Nutr Diet. 2012 Jan;112(1):64-74. doi: 10.1016/j.jada.2011.08.049.
- Beunza JJ, Toledo E, Hu FB, Bes-Rastrollo M, Serrano-Martinez M, Sanchez-Villegas A, Martinez JA, Martinez-Gonzalez MA. Adherence to the Mediterranean diet, long-term weight change, and incident overweight or obesity: the Seguimiento Universidad de Navarra (SUN) cohort. Am J Clin Nutr. 2010 Dec;92(6):1484-93. doi: 10.3945/ajcn.2010.29764. Epub 2010 Oct 20.
- Johns TS, Brown DD, Litwin AH, Goldson G, Buttar RS, Kreimerman J, Lo Y, Reidy KJ, Bauman L, Kaskel F, Melamed ML. Group-Based Care in Adults and Adolescents With Hypertension and CKD: A Feasibility Study. Kidney Med. 2020 Apr 18;2(3):317-325. doi: 10.1016/j.xkme.2020.01.013. eCollection 2020 May-Jun.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2021-12753
- K23DK124644-01A1 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .