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