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

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ClinicalTrials.gov Identifier: NCT02848677
Recruitment Status : Unknown
Verified August 2016 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : July 28, 2016
Last Update Posted : August 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief 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.


Condition or disease Intervention/treatment Phase
Hypertension, Behavioral: Nutritional counseling Behavioral: usual care Phase 2

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Serum Levels of Advanced Glycation End-products After Dietary Intervention in Hypertensive Patients: Study Protocol of a Randomized Clinical Trial.
Study Start Date : November 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : March 2017

Arm Intervention/treatment
Active Comparator: 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.
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.

Sham Comparator: control group
usual care of hypertensive patients.
Behavioral: usual care
usual care of hypertensive patients.




Primary Outcome Measures :
  1. reduction of serum levels of AGEs [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Changes from baseline and six months in blood pressure [ Time Frame: 6 months ]


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848677


Contacts
Contact: Leila B Moreira, MD PHD 55051033597695 lbmoreira@hcpa.edu.br

Locations
Brazil
Leila Beltrami Moreira Recruiting
Porto Alegre, RS, Brazil, 900035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Leila B Moreira, MD PHD Hospital de clínicas de Porto Alegre

Publications of Results:

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02848677     History of Changes
Other Study ID Numbers: 150325
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hospital de Clinicas de Porto Alegre:
advanced glycation end-products
Cardiovascular disease
Low Sodium Diet
vascular inflammation