Women with no history of eating disorders for Anorexia Nervosa

Icahn School of Medicine at Mount Sinai, New York, NY
Anorexia NervosaMetabolic Diet - DietarySupplement
Eligibility
18 - 40
Female

Study Summary

This trial will test a new diet designed to help women with anorexia nervosa remain weight-stable. The diet will be given to women who have been recently restored to normal weight, as well as women with no history of eating disorders, to see if it is effective and safe.

Eligible Conditions
  • Anorexia Nervosa

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Study Objectives

3 Primary · 27 Secondary · Reporting Duration: 10 weeks

10 weeks
Number of adverse events
Percent completion of food
Baseline and 10 weeks
Change in Eating Disorder Examination Questionnaire (EDE-Q)
Change in Weight
Changes in Anxiety using the Beck Anxiety Inventory (BAI)
Changes in Blood Urea Nitrogen (BUN)
Changes in Calcium
Changes in Carbon Dioxide (CO2)
Changes in Chloride
Changes in Clinical Impairments using the Clinical Impairment Assessment (CIA)
Changes in Creatine
Changes in Glucose
Changes in Hematocrit
Changes in Hemoglobin
Changes in High density lipoprotein (HDL cholesterol)
Changes in Low density lipoprotein (LDL cholesterol)
Changes in Mood using the Quick Inventory of Depressive Symptomatology (QIDS)
Changes in Platelet
Changes in Potassium level
Changes in Quality of Life using the Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) from Baseline to 10 Weeks
Changes in Red Blood Count (RBC)
Changes in Sodium level
Changes in Total Cholesterol
Changes in Triglycerides
Changes in White Blood Count (WBC)
Changes in alanine transaminase (ALT)
Changes in albumin
Changes in aspartate aminotransferase (AST)
Changes in hemoglobin A1c
Baseline to 10 weeks
Percent completion of ketone logs

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Women with no history of eating disorders
1 of 2
Women with anorexia nervosa
1 of 2

Active Control

20 Total Participants · 2 Treatment Groups

Primary Treatment: Women with no history of eating disorders · No Placebo Group · N/A

Women with no history of eating disorders
DietarySupplement
ActiveComparator Group · 1 Intervention: Metabolic Diet · Intervention Types: DietarySupplement
Women with anorexia nervosa
DietarySupplement
ActiveComparator Group · 1 Intervention: Metabolic Diet · Intervention Types: DietarySupplement

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 10 weeks

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
800 Previous Clinical Trials
509,496 Total Patients Enrolled
5 Trials studying Anorexia Nervosa
306 Patients Enrolled for Anorexia Nervosa
Tom HildebrandtPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Eligibility Criteria

Age 18 - 40 · Female Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a woman.
You weigh enough based on your height (BMI) and are not underweight.

Frequently Asked Questions

Does this clinical trial have restrictions on age, and if so, does it exclude people aged 85 or older?

"This clinical trial is enrolling participants aged 18 and above, yet below the age of forty." - Anonymous Online Contributor

Unverified Answer

Am I eligible to partake in this research initiative?

"Prospective candidates for this medical trial must be afflicted with anorexia nervosa and between the ages of 18 - 40. The current recruitment goal is 20 patients in total." - Anonymous Online Contributor

Unverified Answer

What is the desired end result of this experiment?

"The primary measure of this 10-week trial is the completion rate of ketone logs and secondary objectives include changes in Quality of Life (QLESQ), Carbon Dioxide levels (CO2), and Clinical Impairment Assessment scores (CIA). These metrics are respectively measured using the Quality of Life Enjoyment and Satisfaction Questionnaire, laboratory test to assess bicarbonate concentration in serum, and a psychosocial functioning scale." - Anonymous Online Contributor

Unverified Answer

Are there currently any opportunities to join the clinical trial?

"Data hosted on clinicaltrials.gov indicates that there is no longer an active search for participants in this particular medical trial. Initially posted on July 1st 2022, the last update was made June 3rd 2022; however, 77 other trials are presently seeking volunteers." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.