Serum Levels of Advanced Glycation End-products After Dietary Intervention in Hypertensive Patients
Primary Purpose
Hypertension,
Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Nutritional counseling
usual care
Sponsored by

About this trial
This is an interventional treatment trial for Hypertension, focused on measuring advanced glycation end-products, Cardiovascular disease, Low Sodium Diet, vascular inflammation
Eligibility 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.
Sites / Locations
- Leila Beltrami MoreiraRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
intervention group
control group
Arm Description
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 of hypertensive patients.
Outcomes
Primary Outcome Measures
reduction of serum levels of AGEs
Secondary Outcome Measures
Changes from baseline and six months in blood pressure
Full Information
NCT ID
NCT02848677
First Posted
July 26, 2016
Last Updated
August 1, 2016
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT02848677
Brief Title
Serum Levels of Advanced Glycation End-products After Dietary Intervention in Hypertensive Patients
Official Title
Serum Levels of Advanced Glycation End-products After Dietary Intervention in Hypertensive Patients: Study Protocol of a Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension,
Keywords
advanced glycation end-products, Cardiovascular disease, Low Sodium Diet, vascular inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Active Comparator
Arm Description
Nutritional counseling implemented by a dietitian for a low sodium diet rich in fruits, vegetables, low fat dairy foods, and low in processed foods.
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
usual care of hypertensive patients.
Intervention Type
Behavioral
Intervention Name(s)
Nutritional counseling
Intervention Description
Nutritional counseling implemented by a dietitian for a low sodium diet rich in fruits, vegetables, low fat dairy foods, and low in processed foods.
Intervention Type
Behavioral
Intervention Name(s)
usual care
Intervention Description
usual care of hypertensive patients.
Primary Outcome Measure Information:
Title
reduction of serum levels of AGEs
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes from baseline and six months in blood pressure
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leila B Moreira, MD PHD
Phone
55051033597695
Email
lbmoreira@hcpa.edu.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leila B Moreira, MD PHD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leila Beltrami Moreira
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
900035-903
Country
Brazil
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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24900944
Citation
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Serum Levels of Advanced Glycation End-products After Dietary Intervention in Hypertensive Patients
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