このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Food Energy Density in Eating Disorders

2019年2月27日 更新者:Ellen Rome、The Cleveland Clinic

Relationship of Energy Density of Foods Within a Nutritional Insufficiency Patient's Diet to Inpatient Hospital Stay Duration, Body Image, Mood and Gastrointestinal Symptoms

Nutritional insufficiency is defined as an inadequate amount of nutrition due to decreased food/caloric intake, often due to an eating disorder, such as anorexia nervosa or bulimia. Often when re-feeding these chronically malnourished patients, they can experience changes in their mood and/or body image, metabolic abnormalities and functional aberrations of their gastrointestinal system described as re-feeding syndrome, which all can adversely effect their recovery. In our pilot study, we are attempting to determine whether adjustments in the amounts of energy dense foods, such as fat, in the current inpatient protocol meal plans will lead to a change in the hospital stay duration, alter their recovery by affecting vital signs, weight or need for supplemental feeds or medications, effect gastrointestinal re-feeding syndrome symptoms (bloating, gastroesophageal reflux, constipation, diarrhea, abdominal pain), and/or effect their perceived body image or cause any changes in their mood.

  1. To determine whether a higher amount of fat calories per day within a normal range in a Nutritional Insufficiency patient's diet will lead to a shorter inpatient hospital stay duration.
  2. To determine whether a higher amount of fat calories per day within a normal range in a Nutritional Insufficiency patient's diet will lead to less gastrointestinal re-feeding syndrome symptoms.
  3. To determine whether a higher amount of fat calories per day within a normal range in a Nutritional Insufficiency patient's diet will effect their body image and/or alter their mood.

調査の概要

詳細な説明

A randomized, double blind pilot study; physicians and patients will be blinded as to which treatment group they will be placed, nutrition therapists will perform randomization and placement into each treatment group for this research study, along with the development of daily meal plan as they typically do when not involved in this study, and therefore they will not be blinded.

Research Procedures

Patients will be placed into one of two groups:

  1. Control: Intake 35-50 grams of fat per day between meals and snacks - this is the typical amount used within our current inpatient re-feeding meal plan, still within a healthy range as it is at the lower end of normal, which given that these patients typically consume a "low fat" diet prior to admission that this amount has been the standard of care for treatment thus far, if they require any supplemental feedings for incomplete meals it will be with the standard lower fat content supplements
  2. Treatment: Intake > 50 grams of fat per day between meals and snacks - still within a healthy range as it is at the higher end of normal, if they require any supplemental feedings for incomplete meals it will be with a higher fat content supplement as dictated by the nutrition therapists

Study instruments - questionnaires distributed and collected on the initial day of admission, on every third day of inpatient stay and on the day of discharge by the nutrition therapists. Due to the lack of research on this method of treatment, there are no questionnaires which have been tested for validity and reliability; therefore we have created our own, which we plan to assess during this pilot study. We also plan to follow-up with the patient and parent(s) at 1 month post-discharge (+/- 1 day) to assess how their re-feeding treatment has been going, along with to assess how they feel and ask about any symptoms they are experiencing.

Tests and procedures - all patients with Nutritional Insufficiency/Eating Disorders admitted to the Cleveland Clinic Children's Hospital follow the Nutritional Insufficiency Protocol, with all screening tests and inpatient evaluation and follow-up occurring regardless of whether they are involved in the current pilot study. As per protocol, these patients will be on strict bed rest with a 24 hour companion supervising the patient at all times, especially monitoring intake and timing of completion of all meals, snacks and/or supplements. It is also standard per protocol that they receive Neutra-phos which is a potassium phosphate and sodium phosphate supplement, twice daily for the initial 5 days of treatment. The screening, daily inpatient evaluation, and study questionnaire distribution will be completed on admission, every 3 days, and at discharge

研究の種類

介入

段階

  • 適用できない

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

9年~24年 (子、大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

• Males and females < 25 years of age admitted through the Adolescent Medicine service for inpatient treatment of Nutritional Insufficiency/Eating Disorder or any significant medical abnormalities associated with Nutritional Insufficiency/Eating Disorder.

Exclusion Criteria:

  • Elevated liver function tests,
  • Elevated pancreatic enzymes,
  • Expected admission < 24 hours duration,
  • Admission on weekends.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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:並列代入
  • マスキング:ダブル

武器と介入

参加者グループ / アーム
介入・治療
他の:Control Arm = Decreased Energy Density
Decreased energy density = 35-50 grams of fat per day between meals and snacks
low fat intake : Intake 35-50 grams of fat per day between meals and snacks
他の:Treatment Arm = Increased Energy Density
increased increased energy density : Intake > 50 grams of fat per day between meals and snacks
increased fat intake : Intake > 50 grams of fat per day between meals and snacks

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
時間枠
Heart Rate
時間枠:1 year
1 year
Blood pressure
時間枠:1 year
1 year
Weight Changes
時間枠:1 year
1 year
Need for constipation medications
時間枠:1 year
1 year
Need for supplemental nutrition
時間枠:1 year
1 year
Need for reflux medications
時間枠:1 year
1 year
Bloating Symptoms
時間枠:1 year
1 year
Constipation symptoms
時間枠:1 year
1 year
Gastroesophageal reflux symptoms
時間枠:1 year
1 year
Perceived body image
時間枠:1 year
1 year

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Ellen Rome, MD、The Cleveland Clinic

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2010年1月1日

一次修了 (実際)

2018年2月1日

研究の完了 (実際)

2018年2月1日

試験登録日

最初に提出

2010年3月19日

QC基準を満たした最初の提出物

2010年3月26日

最初の投稿 (見積もり)

2010年3月29日

学習記録の更新

投稿された最後の更新 (実際)

2019年3月1日

QC基準を満たした最後の更新が送信されました

2019年2月27日

最終確認日

2019年2月1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。

Low fat intakeの臨床試験

3
購読する