Low Sodium Cooking Study

NCT ID: NCT03481322

Last Updated: 2019-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-05
• Study Completion Date: 2018-07-10

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.

Detailed Description

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.

Conditions

Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Cooked diet with controlled amount of salt

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

Group Type: ACTIVE_COMPARATOR

Cooked diet with controlled amount of salt

Intervention Type: DIETARY_SUPPLEMENT

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

Cooked without salt

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

Group Type: PLACEBO_COMPARATOR

Cooked diet with controlled amount of salt

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Cooked diet with controlled amount of salt

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Cardiologia do Rio Grande do Sul

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Instituto de Cardiologia

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

5364/14

Identifier Type: -

Identifier Source: org_study_id