Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Low Sodium Cooking Study

Low Sodium Cooking Study: Acceptance of a Low Sodium Diet in Patients With Heart Diseases: a Crossover Randomized Clinical Trial

The purpose of this study is to evaluate the acceptance of a salt restricted diet cooked with a controlled amount of salt in patients with heart disease. Verifying if there is difference in the acceptance of the standard and hyposodic diets cooked with controlled amount of salt.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Patients will be randomized into two groups. Patients in group 1 will receive on the first day the standard hyposodic diet - cooked without salt, with 2g of salt (sachet) to be added by the patient at each meal (lunch and dinner). After the first day dinner, these patients will respond to the diet acceptance questionnaire. On the second day, patients in this same group will receive the hyposodic diet cooked with controlled amount of salt at lunch and dinner. The hyposodic diet cooked with controlled amount of salt is cooked with 2 grams of salt that is divided for all the preparations, according to standardized recipes. After dinner, the patients will respond again to the diet acceptance questionnaire, however referring to the diet received in this day.

Patients in group 2 will receive the same intervention, however changing the order of reception of the diets, so, on the first day they will receive the cooked hyposodic diet with controlled amount of salt and on the second day the standard hyposodic diet (salt sachet).

The questionnaire applied refers to the reasons for not accepting the diet. The same questionnaire will be applied twice for each patient, after each of the diets offered - standard hyposodic and hyposodic cooked with controlled amount of salt.

The amount of food that was ingested by the patients, for both diets, will be evaluated by weighing the food that remains in the thermal of each meal. Leftovers of the preparations should be stored properly in plastic bags, separated by patient and properly identified, to be weighed in an electronic scale and immediately discarded in an appropriate place. It will be noted how much the patient refused from each preparation, in grams. The value obtained will be subtracted from the quantity, in grams, of the same preparation offered to the patient. The result of this operation (amount in grams of the preparation accepted / ingested by the individual) will be converted into percent. To determine the weight of the sended food, a thermometer will be weighed, which will be sent on the day, according to the standard home measure used.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

68

Fase

  • Ikke anvendelig

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
        • Instituto de Cardiologia

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • cardiac patients hospitalized in a clinical unit with prescription of hyposodic diet

Exclusion Criteria:

  • prescription of diet with restrictions or changes in consistency;
  • patients who prefer to receive soup or other non-standard food in the diet;
  • pacients without unable to respond to the questionnaire.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Cooked diet with controlled amount of salt
Patients will receive intervention diet (cooked with controlled amount of salt)
Cooked diet with controlled amount of salt by nutritionist - 2 grams of salt per patient
Placebo komparator: Cooked without salt
Patients will receive the standard diet (cooked without salt and 2 grams of salt separated will be added by the patient)
Cooked diet with controlled amount of salt by nutritionist - 2 grams of salt per patient

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
percentage of dietary intake of each diet
Tidsramme: 1 day
The amount of food that was ingested by the patients for the two diets will be evaluated by weighing the remaining food in the thermal dish of each meal. The leftovers of the preparations will be weighed in an electronic scale and it will be noted how much the patient refused of each preparation, in grams. The value obtained will be subtracted from the quantity, in grams, of the same preparation offered to the patient. The result of this operation (amount in grams of the preparation accepted / ingested by the individual) will be converted into percent.
1 day

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
difference in the acceptance of standard and hyposodic diets cooked with controlled amount of salt
Tidsramme: 2 days
Comparison of the percentages of acceptance of the two diets, in total weight of the day and analysis if there was difference between the preparations
2 days

Samarbejdspartnere og efterforskere

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

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 (Faktiske)

5. september 2017

Primær færdiggørelse (Faktiske)

8. juli 2018

Studieafslutning (Faktiske)

10. juli 2018

Datoer for studieregistrering

Først indsendt

22. marts 2018

Først indsendt, der opfyldte QC-kriterier

22. marts 2018

Først opslået (Faktiske)

29. marts 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. januar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. januar 2019

Sidst verificeret

1. januar 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 5364/14

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

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 Hjerte sygdom

Abonner