Low Sodium Cooking Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Disease

Intervention / Treatment
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* Dietary Supplement: Cooked diet with controlled amount of salt


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cooked diet with controlled amount of salt<br>Patients will receive intervention diet (cooked with controlled amount of salt) | Dietary Supplement: Cooked diet with controlled amount of salt<br>* Cooked diet with controlled amount of salt by nutritionist - 2 grams of salt per patient<br>|
| Placebo Comparator: Cooked without salt<br>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<br>* Cooked diet with controlled amount of salt by nutritionist - 2 grams of salt per patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in the acceptance of standard and hyposodic diets cooked with controlled amount of salt | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sodium chloride, diet, cooking