Low Sodium Cooking Study

NCT03481322 | Completed DMC

• 1 other identifier: 5364/14
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Disease

Keywords

sodium chloride; diet; cooking

Outcome Measures

Primary Outcomes (1)

• percentage of dietary intake of each diet

  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

Secondary Outcomes (1)

• difference in the acceptance of standard and hyposodic diets cooked with controlled amount of salt

  2 days

Study Arms (2)

Cooked diet with controlled amount of salt

ACTIVE COMPARATOR

Patients will receive intervention diet (cooked with controlled amount of salt)

Dietary Supplement: Cooked diet with controlled amount of salt

Cooked without salt

PLACEBO COMPARATOR

Patients will receive the standard diet (cooked without salt and 2 grams of salt separated will be added by the patient)

Dietary Supplement: Cooked diet with controlled amount of salt

Interventions

Cooked diet with controlled amount of salt DIETARY_SUPPLEMENT

Cooked diet with controlled amount of salt by nutritionist - 2 grams of salt per patient

Cooked diet with controlled amount of salt; Cooked without salt

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead

Study Sites (1)

Instituto de Cardiologia

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: March 29, 2018
• Study Start: September 5, 2017
• Primary Completion: July 8, 2018
• Study Completion: July 10, 2018
• Last Updated: January 9, 2019

Record last verified: 2019-01

Locations

BR (1)