Food Energy Density in Eating Disorders

NCT ID: NCT01095107

Last Updated: 2019-03-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2018-02-28

Brief 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.

Detailed Description

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

Conditions

Nutritional Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Control Arm = Decreased Energy Density

Decreased energy density = 35-50 grams of fat per day between meals and snacks

Group Type: OTHER

Low fat intake

Intervention Type: DIETARY_SUPPLEMENT

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

Treatment Arm = Increased Energy Density

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

Group Type: OTHER

Increased fat intake

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Low fat intake

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

Intervention Type: DIETARY_SUPPLEMENT

Increased fat intake

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Ellen Rome

Staff, General Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ellen Rome, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Other Identifiers

CCCH-KW

Identifier Type: -

Identifier Source: org_study_id