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Dietary Supplement

Metabolic Diet for Anorexia Nervosa

N/A
Recruiting
Led By Chinara Tate
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)
Must not have
Significant current medical illness or metabolic conditions, including diabetes mellitus and pregnancy
Subjects are to be free of any medications that could affect metabolism, as discussed with study physician, for 2 weeks prior to primary study visit for glucose function testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any major illnesses like diabetes or am not pregnant.
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I haven't taken any metabolism-affecting medications for 2 weeks.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of adverse events
Percent completion of food
Percent completion of ketone logs
Secondary study objectives
Change in Eating Disorder Examination Questionnaire (EDE-Q)
Change in Weight
Changes in Anxiety using the Beck Anxiety Inventory (BAI)
+24 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
903 Previous Clinical Trials
541,748 Total Patients Enrolled
5 Trials studying Anorexia Nervosa
306 Patients Enrolled for Anorexia Nervosa
Chinara TatePrincipal InvestigatorIcahn School of Medicine at Mount Sinai
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
~0 spots leftby Dec 2024
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