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Dietary Supplement

Metabolic Diet for Anorexia Nervosa

N/A

Recruiting

Led By Tom Hildebrandt

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age at least 18 and not over 40

Weight-restored from underweight BMI (under 18.5 kg/m2) within the past 6 months (WR-AN only)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 weeks

Awards & highlights

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.

Who is the study for?

This trial is for adult women aged 18-40 who have recovered from anorexia nervosa to a healthy weight within the last 6 months. They must speak English, be medically stable with normal vital signs and blood tests, and not be on metabolism-affecting medications. Women without eating disorders can also join. Those with active depression, psychosis, bipolar disorder, recent suicide attempts or acute risk, significant medical conditions like diabetes or pregnancy are excluded.Check my eligibility

What is being tested?

The study examines the Metabolic Diet's safety and effectiveness in maintaining weight stability in women who've recently gained back weight after being underweight due to anorexia nervosa. Participants will work with dietitians weekly to follow this special diet while their health and psychological changes are monitored.See study design

What are the potential side effects?

While specific side effects of the Metabolic Diet aren't listed, participants will be closely watched for any negative reactions such as digestive issues or metabolic changes during their diet implementation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 40 years old.

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I have regained weight to a healthy level after being underweight.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of adverse events

Percent completion of food

Percent completion of ketone logs

Secondary outcome measures

Change in Eating Disorder Examination Questionnaire (EDE-Q)

Change in Weight

Changes in Anxiety using the Beck Anxiety Inventory (BAI)

+24 more

Trial Design

2Treatment groups

Active Control

Group I: Women with anorexia nervosaActive Control1 Intervention

adult women with anorexia nervosa who have been recently restored to normal weight

Group II: Women with no history of eating disordersActive Control1 Intervention

adult women with no history of eating disorders

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

860 Previous Clinical Trials

524,456 Total Patients Enrolled

5 Trials studying Anorexia Nervosa

306 Patients Enrolled for Anorexia Nervosa

Tom HildebrandtPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Media Library

Metabolic Diet (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05197309 — N/A

Anorexia Nervosa Research Study Groups: Women with anorexia nervosa, Women with no history of eating disorders

Anorexia Nervosa Clinical Trial 2023: Metabolic Diet Highlights & Side Effects. Trial Name: NCT05197309 — N/A

Metabolic Diet (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05197309 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Metabolic Diet for Relapse Prevention in Anorexia Nervosa

Tom Hildebrandt 2022. "Metabolic Diet for Relapse Prevention in Anorexia Nervosa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05197309.

All > Anorexia Nervosa