Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Food Energy Density in Eating Disorders

27. februar 2019 opdateret af: 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.

Studieoversigt

Status

Trukket tilbage

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

9 år til 24 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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
Andet: 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

Hvad måler undersøgelsen?

Primære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Ellen Rome, MD, The Cleveland Clinic

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2010

Primær færdiggørelse (Faktiske)

1. februar 2018

Studieafslutning (Faktiske)

1. februar 2018

Datoer for studieregistrering

Først indsendt

19. marts 2010

Først indsendt, der opfyldte QC-kriterier

26. marts 2010

Først opslået (Skøn)

29. marts 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. marts 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. februar 2019

Sidst verificeret

1. februar 2019

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Low fat intake

3
Abonner