Low Sodium Cooking Study
Primary Purpose
Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cooked diet with controlled amount of salt
Sponsored by

About this trial
This is an interventional supportive care trial for Heart Disease focused on measuring sodium chloride, diet, cooking
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.
Sites / Locations
- Instituto de Cardiologia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Cooked diet with controlled amount of salt
Cooked without salt
Arm Description
Patients will receive intervention diet (cooked with controlled amount of salt)
Patients will receive the standard diet (cooked without salt and 2 grams of salt separated will be added by the patient)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03481322
First Posted
March 22, 2018
Last Updated
January 8, 2019
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
1. Study Identification
Unique Protocol Identification Number
NCT03481322
Brief Title
Low Sodium Cooking Study
Official Title
Low Sodium Cooking Study: Acceptance of a Low Sodium Diet in Patients With Heart Diseases: a Crossover Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 5, 2017 (Actual)
Primary Completion Date
July 8, 2018 (Actual)
Study Completion Date
July 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Cardiologia do Rio Grande do Sul
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease
Keywords
sodium chloride, diet, cooking
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cooked diet with controlled amount of salt
Arm Type
Active Comparator
Arm Description
Patients will receive intervention diet (cooked with controlled amount of salt)
Arm Title
Cooked without salt
Arm Type
Placebo Comparator
Arm Description
Patients will receive the standard diet (cooked without salt and 2 grams of salt separated will be added by the patient)
Intervention Type
Dietary Supplement
Intervention Name(s)
Cooked diet with controlled amount of salt
Intervention Description
Cooked diet with controlled amount of salt by nutritionist - 2 grams of salt per patient
Primary Outcome Measure Information:
Title
percentage of dietary intake of each diet
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
difference in the acceptance of standard and hyposodic diets cooked with controlled amount of salt
Description
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
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Instituto de Cardiologia
City
Porto Alegre
State/Province
RS
Country
Brazil
12. IPD Sharing Statement
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Low Sodium Cooking Study
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