Low Sodium Cooking Study
Low Sodium Cooking Study: Acceptance of a Low Sodium Diet in Patients With Heart Diseases: a Crossover Randomized Clinical Trial
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
RS
-
Porto Alegre、RS、ブラジル
- Instituto de Cardiologia
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:クロスオーバー割り当て
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ: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
|
|
プラセボコンパレーター: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
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
percentage of dietary intake of each diet
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
difference in the acceptance of standard and hyposodic diets cooked with controlled amount of salt
時間枠: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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。