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Ketone Supplement
Ketone Supplementation for Eating Disorders
N/A
Recruiting
Led By Guido Frank, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to study completion, up to 2 weeks
Awards & highlights
Summary
This trial will study the effects of ketone supplements on eating habits, mood, and anxiety in people with anorexia or bulimia.
Who is the study for?
This trial is for individuals with Anorexia Nervosa, Bulimia Nervosa, or OSFED related to these conditions. Participants must be medically stable and able to communicate in English. They should respond promptly to study messages up to six times a day. People with certain medical conditions, recent substance abuse, significant brain trauma, intellectual disabilities or allergies to the drink's ingredients cannot join.
What is being tested?
The study examines how a Kenetik Ketone Drink affects eating behaviors, mood and anxiety in those with anorexia or bulimia nervosa. It includes initial EEG tests after taking either the ketone drink or placebo on two consecutive days (randomized), followed by two weeks of twice-daily ketone supplementation.
What are the potential side effects?
Potential side effects are not detailed but may include reactions typical of dietary supplements such as digestive discomfort. Specific risks could relate to ingredients like D-BHB and various additives present in the KenetikR drink.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to study completion, up to 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to study completion, up to 2 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Eating Disorders
Eating Disorders
Weight Change
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ketone SupplementationExperimental Treatment1 Intervention
Subjects will ingest 2 daily doses of Kenetik ketone drink supplementation for 14 days.
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Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,157 Previous Clinical Trials
1,571,379 Total Patients Enrolled
5 Trials studying Bulimia Nervosa
979 Patients Enrolled for Bulimia Nervosa
Guido Frank, MDPrincipal InvestigatorUniversity of California, San Diego
5 Previous Clinical Trials
438 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with an eating disorder (Anorexia, Bulimia, or OSFED).I have a condition like diabetes or am pregnant, affecting my eating or weight.I have a medical condition like type 1 diabetes or acute pancreatitis.
Research Study Groups:
This trial has the following groups:- Group 1: Ketone Supplementation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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