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

1. august 2016 opdateret af: Hospital de Clinicas de Porto Alegre

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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

120

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • RS
      • Porto Alegre, RS, Brasilien, 900035-903
        • Rekruttering
        • Leila Beltrami Moreira

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
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-komparator: control group
usual care of hypertensive patients.
usual care of hypertensive patients.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
reduction of serum levels of AGEs
Tidsramme: 6 months
6 months

Sekundære resultatmål

Resultatmål
Tidsramme
Changes from baseline and six months in blood pressure
Tidsramme: 6 months
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Leila B Moreira, MD PHD, Hospital de Clinicas de Porto Alegre

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2015

Primær færdiggørelse (Forventet)

1. november 2016

Studieafslutning (Forventet)

1. marts 2017

Datoer for studieregistrering

Først indsendt

26. juli 2016

Først indsendt, der opfyldte QC-kriterier

27. juli 2016

Først opslået (Skøn)

28. juli 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. august 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. august 2016

Sidst verificeret

1. august 2016

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Forhøjet blodtryk,

Kliniske forsøg med Nutritional counseling

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