- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02848677
Serum Levels of Advanced Glycation End-products After Dietary Intervention in Hypertensive Patients
Serum Levels of Advanced Glycation End-products After Dietary Intervention in Hypertensive Patients: Study Protocol of a Randomized Clinical Trial.
Cardiovascular disease (CVD) is considered the main cause of mortality in the western world. There are many factors that contribute to the onset and progression of cardiovascular disease, including hypertension. Hypertension is a multi-factorial condition that includes nutritional disorders in its causality line. It is believed that advanced glycation end-products (AGEs) is one of the pathophysiological causes that explain the occurrence of high blood pressure in diabetic patients. This study has the role of describing the protocol of a randomized clinical trial aiming to evaluate changes in serum levels of end products of advanced glycation after an intervention for eating habit changes in hypertensive individuals.
The investigators designed a randomized clinical trial, with non-blinded assessment of outcomes. Participants will be recruited from the outpatient clinic for hypertension of a public hospital in Porto Alegre, aged from 40 to 80 years old and without diabetes. Hypertension is defined as systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg, or antihypertensive medication use. Participants will be assigned to one of two groups. The intervention group will receive monthly educational intervention sessions for low salt diet, high in fruits and vegetables, and low in processed foods for a period of 6 months. Besides these, the intervention group will receive a standard telephone interview every two weeks to motivate them to follow the diet. The control group will receive the usual counseling for low sodium diet in monthly appointment with a dietitian, following the hypertension care clinic protocol.
This study aims to investigate if there are significant changes in serum levels of advanced glycation end products, after the nutritional intervention with diet guidance in fruits, vegetables, low in sodium and processed foods in hypertensive patients because several studies have shown that less processed food rich in antioxidants with low sodium content, play an important role in reducing levels of AGEs which are precursors of vascular inflammation and progression of cardiovascular diseases.
연구 개요
상세 설명
There will be a randomized, non-blinded, parallel-group clinical trial comparing serum AGESs level in patients randomized to receive an educational program of diet counseling or the usual care.
Study population: Hypertensive patients attending the outpatient clinic for hypertension treatment at a university-affiliated hospital in southern Brazil.
Intervention group - Nutritional counseling implemented by a dietitian for a low sodium diet rich in fruits, vegetables, low fat dairy foods, and low in processed foods. Patients will be evaluated every month.
Control group - usual care of hypertensive patients. Patients will be evaluated after 6 months.
연구 유형
등록 (예상)
단계
- 2 단계
연락처 및 위치
연구 장소
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RS
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Porto Alegre, RS, 브라질, 900035-903
- 모병
- Leila Beltrami Moreira
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- It will be included patients aged between 40 and 80 years old,
- diagnosed with hypertension defined by systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg,
- or the use of drugs for hypertension; patients not following nutritional counseling in the last 6 months.
Exclusion Criteria:
- will be patients with inflammatory diseases, receiving chemotherapy treatment,
- diagnosed with diabetes mellitus,
- referred for nutritional counseling or unable to conduct the interview and to participate in the intervention program,
- pregnant women and nursing mothers.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: intervention group
Nutritional counseling implemented by a dietitian for a low sodium diet rich in fruits, vegetables, low fat dairy foods, and low in processed foods.
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Nutritional counseling implemented by a dietitian for a low sodium diet rich in fruits, vegetables, low fat dairy foods, and low in processed foods.
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가짜 비교기: control group
usual care of hypertensive patients.
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usual care of hypertensive patients.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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reduction of serum levels of AGEs
기간: 6 months
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6 months
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Changes from baseline and six months in blood pressure
기간: 6 months
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6 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Leila B Moreira, MD PHD, Hospital de Clinicas de Porto Alegre
간행물 및 유용한 링크
일반 간행물
- Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14. Erratum In: JAMA. 2003 Jul 9;290(2):197.
- Lewington S, Clarke R, Qizilbash N, Peto R, Collins R; Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002 Dec 14;360(9349):1903-13. doi: 10.1016/s0140-6736(02)11911-8. Erratum In: Lancet. 2003 Mar 22;361(9362):1060.
- d'Almeida KS, Souza GC, Rabelo-Silva ER. Validity and reliability of the Dietary Sodium Restriction Questionnaire (DSRQ). Nutr Hosp. 2013 Sep-Oct;28(5):1702-9. doi: 10.3305/nh.2013.28.5.6679.
- Prasad C, Imrhan V, Marotta F, Juma S, Vijayagopal P. Lifestyle and Advanced Glycation End Products (AGEs) Burden: Its Relevance to Healthy Aging. Aging Dis. 2014 Jun 1;5(3):212-7. doi: 10.14336/AD.2014.0500212. eCollection 2014 Jun.
- Ward MS, Fortheringham AK, Cooper ME, Forbes JM. Targeting advanced glycation endproducts and mitochondrial dysfunction in cardiovascular disease. Curr Opin Pharmacol. 2013 Aug;13(4):654-61. doi: 10.1016/j.coph.2013.06.009. Epub 2013 Jul 16.
- Gul A, Rahman MA, Salim A, Simjee SU. Advanced glycation end-products in senile diabetic and non-diabetic patients with cardiovascular complications. Age (Dordr). 2008 Dec;30(4):303-9. doi: 10.1007/s11357-008-9072-1. Epub 2008 Sep 3.
- Erdine S, Ari O, Zanchetti A, Cifkova R, Fagard R, Kjeldsen S, Mancia G, Poulter N, Rahn KH, Rodicio JL, Ruilope LM, Staessen J, van Zwieten P, Waeber B, Williams B. ESH-ESC guidelines for the management of hypertension. Herz. 2006 Jun;31(4):331-8. doi: 10.1007/s00059-006-2829-3.
- Nobre F. [Introduction: Brazilian guidelines on hypertension VI. Brazilian Society of Cardiology, Brazilian Society of Hypertension, Brazilian Society of Nephrology]. J Bras Nefrol. 2010 Sep;32 Suppl 1:III. doi: 10.1590/s0101-28002010000500002. No abstract available. Portuguese.
- Vasdev S, Stuckless J, Richardson V. Role of the immune system in hypertension: modulation by dietary antioxidants. Int J Angiol. 2011 Dec;20(4):189-212. doi: 10.1055/s-0031-1288941.
- Bodiga VL, Eda SR, Bodiga S. Advanced glycation end products: role in pathology of diabetic cardiomyopathy. Heart Fail Rev. 2014 Jan;19(1):49-63. doi: 10.1007/s10741-013-9374-y.
- Dhar I, Dhar A, Wu L, Desai KM. Methylglyoxal, a reactive glucose metabolite, increases renin angiotensin aldosterone and blood pressure in male Sprague-Dawley rats. Am J Hypertens. 2014 Mar;27(3):308-16. doi: 10.1093/ajh/hpt281. Epub 2014 Jan 16.
- Finot PA. Historical perspective of the Maillard reaction in food science. Ann N Y Acad Sci. 2005 Jun;1043:1-8. doi: 10.1196/annals.1333.001.
- Kwak EJ, Lim SI. The effect of sugar, amino acid, metal ion, and NaCl on model Maillard reaction under pH control. Amino Acids. 2004 Aug;27(1):85-90. doi: 10.1007/s00726-004-0067-7. Epub 2004 Feb 27.
- Poulsen MW, Bak MJ, Andersen JM, Monosik R, Giraudi-Futin AC, Holst JJ, Nielsen J, Lauritzen L, Larsen LH, Bugel S, Dragsted LO. Effect of dietary advanced glycation end products on postprandial appetite, inflammation, and endothelial activation in healthy overweight individuals. Eur J Nutr. 2014;53(2):661-72. doi: 10.1007/s00394-013-0574-y. Epub 2013 Aug 9.
- Wu ET, Liang JT, Wu MS, Chang KC. Pyridoxamine prevents age-related aortic stiffening and vascular resistance in association with reduced collagen glycation. Exp Gerontol. 2011 Jun;46(6):482-8. doi: 10.1016/j.exger.2011.02.001. Epub 2011 Feb 18.
- Barbosa JH, Oliveira SL, Seara LT. [The role of advanced glycation end-products (AGEs) in the development of vascular diabetic complications]. Arq Bras Endocrinol Metabol. 2008 Aug;52(6):940-50. doi: 10.1590/s0004-27302008000600005. Portuguese.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
Nutritional counseling에 대한 임상 시험
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University Health Network, Toronto완전한
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Maastricht University Medical CenterDSM Nutritional Products, Inc.; The Netherlands Asthma Foundation완전한
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Maastricht University Medical CenterDSM Nutritional Products, Inc.알려지지 않은