Food Energy Density in Eating Disorders

• ClinicalTrials.gov Identifier: NCT01095107
• Recruitment Status: Withdrawn
• First Posted: March 29, 2010
• Last Update Posted: March 1, 2019
• Sponsor: The Cleveland Clinic
• Information provided by (Responsible Party): Ellen Rome, The Cleveland Clinic

Tracking Information

• First Submitted Date: March 19, 2010
• First Posted Date: March 29, 2010
• Last Update Posted Date: March 1, 2019
• Actual Study Start Date: January 2010
• Actual Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 26, 2010)

• Heart Rate [ Time Frame: 1 year ]
• Blood pressure [ Time Frame: 1 year ]
• Weight Changes [ Time Frame: 1 year ]
• Need for constipation medications [ Time Frame: 1 year ]
• Need for supplemental nutrition [ Time Frame: 1 year ]
• Need for reflux medications [ Time Frame: 1 year ]
• Bloating Symptoms [ Time Frame: 1 year ]
• Constipation symptoms [ Time Frame: 1 year ]
• Gastroesophageal reflux symptoms [ Time Frame: 1 year ]
• Perceived body image [ Time Frame: 1 year ]

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Food Energy Density in Eating Disorders
• Official Title: Relationship of Energy Density of Foods Within a Nutritional Insufficiency Patient's Diet to Inpatient Hospital Stay Duration, Body Image, Mood and Gastrointestinal Symptoms

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

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Supportive Care
• Condition: Nutritional Insufficiency

Intervention

• 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

Study Arms

• Control Arm = Decreased Energy Density
  Decreased energy density = 35-50 grams of fat per day between meals and snacks
  Intervention: Dietary Supplement: Low fat intake
• Treatment Arm = Increased Energy Density
  increased increased energy density : Intake > 50 grams of fat per day between meals and snacks
  Intervention: Dietary Supplement: Increased fat intake

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: February 27, 2019): 0
• Original Estimated Enrollment (submitted: March 26, 2010): 20
• Actual Study Completion Date: February 2018
• Actual Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 9 Years to 24 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01095107
• Other Study ID Numbers: CCCH-KW
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Ellen Rome, The Cleveland Clinic
• Study Sponsor: The Cleveland Clinic
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ellen Rome, MD; The Cleveland Clinic

• PRS Account: The Cleveland Clinic
• Verification Date: February 2019