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Food Energy Density in Eating Disorders

NCT01095107 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-03-01

No results posted yet for this study

Summary

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.

Conditions

  • Nutritional Insufficiency

Interventions

DIETARY_SUPPLEMENT

Low fat intake

low fat intake : Intake 35-50 grams of fat per day between meals and snacks

DIETARY_SUPPLEMENT

Increased fat intake

increased fat intake : Intake \> 50 grams of fat per day between meals and snacks

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Ellen Rome, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2018-02-28
Completion
2018-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01095107 on ClinicalTrials.gov