Individualized vs High-Calorie Refeeding for Anorexia Nervosa

(i-STRONG Trial)

Recruiting at 1 trial location

Overseen By Andrea Garber, PHD, RD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Bulimia, Pregnancy, Chronic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1-2 weeks

74 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary purpose of the trial is to compare the efficacy and safety of Individualized Caloric Refeeding (ICR) to the new standard of care, Higher Calorie Refeeding (HCR), in hospitalized patients with atypical anorexia nervosa (AAN), and clinical remission over one year of follow-up.

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.

What data supports the effectiveness of the treatment Higher Calorie Refeeding (HCR) for Anorexia Nervosa?

Research shows that Higher Calorie Refeeding (HCR) can help patients with anorexia nervosa gain weight faster and leave the hospital sooner without increasing the risk of refeeding syndrome, a serious condition that can occur when feeding is restarted after malnutrition. Studies also suggest that HCR is safe and effective for children and adolescents with anorexia nervosa, even for those with very low body weight. ^{1 2 3 4 5}

Is higher calorie refeeding safe for humans?

Research shows that higher calorie refeeding (HCR) in patients with anorexia nervosa is generally safe, with no increase in safety events compared to lower calorie refeeding. It helps restore medical stability faster without adverse effects on heart health or other biochemical markers. ^{4 5 6 7 8}

How does the treatment for anorexia nervosa differ from other treatments?

The treatment for anorexia nervosa using higher calorie refeeding (HCR) is unique because it involves starting with a higher calorie intake to restore weight and medical stability faster, compared to the traditional approach of starting with lower calories and increasing slowly. This method has been shown to shorten hospital stays and improve initial weight gain without increasing the risk of refeeding syndrome, a serious condition that can occur when feeding is restarted after malnutrition. ^{2 4 5 6 7}

Research Team

Andrea K Garber, RD, PhD

Principal Investigator

University of California, San Francisco

Neville H Golden, MD

Principal Investigator

Stanford University

Eligibility Criteria

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

Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for AAN

I am hospitalized with unstable health due to very low heart rate, blood pressure, or body temperature.

I am between 12 and 24 years old.

Exclusion Criteria

I am not currently experiencing thoughts of harming myself or others, nor am I experiencing a break from reality.

I have not been hospitalized for refeeding in the last 6 months.

I have a long-term illness affecting my immune system or kidneys.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are hospitalized and receive either Individualized Caloric Refeeding (ICR) or Higher Calorie Refeeding (HCR) to achieve medical stability

1-2 weeks

Daily monitoring in hospital

Follow-up

Participants are monitored for metabolic, hormonal, and psychological markers to develop a definition of clinical remission in AAN

12 months

Visits at 3, 6, 9, and 12 months

Treatment Details

Interventions

• Higher Calorie Refeeding (HCR)
• Individualized Caloric Refeeding (ICR)

Trial Overview The study compares Individualized Caloric Refeeding (ICR) to Higher Calorie Refeeding (HCR), focusing on safety and how well they work in treating patients with atypical anorexia nervosa over a year of follow-up.

Participant Groups

Group I: Individualized Caloric Refeeding (ICR) Experimental Treatment 1 Intervention

Starting 50 kcal/kg/d, increasing by 200 kcal/d to goal

Group II: Higher Calorie Refeeding (HCR) Active Control 1 Intervention

Starting 2000 kcal/d, increasing by 200 kcal/d to goal

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Outcomes of an inpatient refeeding protocol in youth with Anorexia Nervosa and atypical Anorexia Nervosa at Children's Hospitals and Clinics of Minnesota. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Short-term Outcomes of the Study of Refeeding to Optimize Inpatient Gains for Patients With Anorexia Nervosa: A Multicenter Randomized Clinical Trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Clinical Outcomes of Refeeding Syndrome: A Systematic Review of High vs. Low-Calorie Diets for the Treatment of Anorexia Nervosa and Related Eating Disorders in Children and Adolescents. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Practice-Based Evidence and Clinical Guidance to Support Accelerated Re-Nutrition of Patients With Anorexia Nervosa. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Higher-Calorie Refeeding in Anorexia Nervosa: 1-Year Outcomes From a Randomized Controlled Trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Outcomes of a higher calorie inpatient refeeding protocol in Asian adolescents with anorexia nervosa. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Hospital-based higher calorie refeeding and mealtime distress in adolescents and young adults with anorexia nervosa or atypical anorexia nervosa. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Refeeding Low Weight Hospitalized Adolescents With Anorexia Nervosa: A Multicenter Randomized Controlled Trial. [2017]