Individualized vs High-Calorie Refeeding for Anorexia Nervosa
(i-STRONG Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores two methods to help patients with atypical anorexia nervosa regain weight safely and effectively. It compares Individualized Caloric Refeeding (ICR), which adjusts calorie intake for each person, with Higher Calorie Refeeding (HCR), which begins at a higher calorie level. The goal is to determine which method leads to better health outcomes over a year. Suitable participants have been diagnosed with atypical anorexia nervosa and are currently hospitalized due to health concerns related to the illness. As an unphased study, this trial provides a unique opportunity to enhance understanding of effective treatments for atypical anorexia nervosa.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Higher Calorie Refeeding (HCR) is safe for people hospitalized with anorexia nervosa. Studies have found that HCR helps patients achieve medical stability faster without increasing risks such as refeeding syndrome, a serious condition that can occur if feeding starts too quickly. Patients on HCR also spent less time in the hospital.
In contrast, less information exists about Individualized Caloric Refeeding (ICR). Some research suggests that personalized plans might lead to longer hospital stays, but they do not indicate any major safety concerns.
In summary, HCR is well-tolerated and has strong evidence supporting its safety. ICR appears safe as well, but there is less data to confirm this.12345Why are researchers excited about this trial?
Researchers are excited about these treatments for anorexia nervosa because they explore different approaches to refeeding, which is a critical part of recovery. Unlike traditional methods that might follow a more standardized calorie increase, Individualized Caloric Refeeding (ICR) starts at 50 kcal/kg per day and tailors increases by 200 calories each day to meet personal goals, potentially offering a more personalized approach to patient care. On the other hand, Higher Calorie Refeeding (HCR) begins at a set 2000 kcal per day, also increasing by 200 calories daily, which might help kickstart the body's recovery process more aggressively. These tailored strategies aim to optimize nutritional rehabilitation while minimizing potential complications, providing new hope for improving outcomes in anorexia treatment.
What evidence suggests that this trial's treatments could be effective for atypical anorexia nervosa?
This trial will compare Higher Calorie Refeeding (HCR) with Individualized Caloric Refeeding (ICR) for patients with anorexia nervosa. Research has shown that HCR helps patients gain weight and achieve medical stability faster than lower-calorie methods. One study found that HCR shortened hospital stays by about four days on average. Other research demonstrated that HCR enabled patients to reach medical stability much sooner, with a 67% faster rate of achieving stability.
In contrast, ICR, another treatment option in this trial, lacks extensive research support. Some studies suggest that ICR might result in slower weight gain and longer hospital stays compared to fixed higher-calorie plans. While ICR aims to customize the diet for each person, less evidence supports its effectiveness compared to the well-studied HCR approach.12346Who Is on the Research Team?
Andrea K Garber, RD, PhD
Principal Investigator
University of California, San Francisco
Neville H Golden, MD
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
This trial is for hospitalized youths aged 12-24 with atypical anorexia nervosa, who meet specific health criteria like low heart rate or blood pressure. It's not for those with bulimia, recent refeeding hospital stays, chronic diseases, pregnancy, or acute mental health crises.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are hospitalized and receive either Individualized Caloric Refeeding (ICR) or Higher Calorie Refeeding (HCR) to achieve medical stability
Follow-up
Participants are monitored for metabolic, hormonal, and psychological markers to develop a definition of clinical remission in AAN
What Are the Treatments Tested in This Trial?
Interventions
- Higher Calorie Refeeding (HCR)
- Individualized Caloric Refeeding (ICR)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Stanford University
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator