Serum Levels of Advanced Glycation End-products After Dietary Intervention in Hypertensive Patients

Hypertension, Clinical Trial

Official title:

Serum Levels of Advanced Glycation End-products After Dietary Intervention in Hypertensive Patients: Study Protocol of a Randomized Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02848677
• Other study ID #: 150325
• Status: Recruiting
• Phase: Phase 2
• First received: July 26, 2016
• Last updated: August 1, 2016
• Start date: November 2015
• Est. completion date: March 2017

Study information

• Verified date: August 2016
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Leila B Moreira, MD PHD
• Phone: 55051033597695
• Email: lbmoreira[@]hcpa.edu.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension,

Intervention

Behavioral:
• Nutritional counseling
Nutritional counseling implemented by a dietitian for a low sodium diet rich in fruits, vegetables, low fat dairy foods, and low in processed foods.
• usual care
usual care of hypertensive patients.

Locations

Country	Name	City	State
Brazil	Leila Beltrami Moreira	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (16)

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. Review. Portuguese. — View Citation

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. Review. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Finot PA. Historical perspective of the Maillard reaction in food science. Ann N Y Acad Sci. 2005 Jun;1043:1-8. — View Citation

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. — View Citation

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. Epub 2004 Feb 27. — View Citation

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. 20 — View Citation

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. Portuguese. — View Citation

Poulsen MW, Bak MJ, Andersen JM, Monošík R, Giraudi-Futin AC, Holst JJ, Nielsen J, Lauritzen L, Larsen LH, Bügel S, Dragsted LO. Effect of dietary advanced glycation end products on postprandial appetite, inflammation, and endothelial activation in health — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction of serum levels of AGEs		6 months	Yes
Secondary	Changes from baseline and six months in blood pressure		6 months	Yes