Ketone Supplementation for Eating Disorders

Overseen By Guido Frank, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Psychotic illness, Substance abuse, Diabetes, others

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

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how ketone supplements affect eating habits, mood, and anxiety in individuals with anorexia or bulimia. Researchers compare the effects of a ketone drink (Kenetik Ketone Drink) to a placebo, analyzing brain activity through EEG, which records electrical activity in the brain. Participants will consume the ketone supplement twice daily for two weeks. Suitable candidates include individuals with anorexia or bulimia who are medically stable and can communicate in English. As an unphased trial, this study provides participants a unique opportunity to contribute to understanding potential new treatments for eating disorders.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that ketone supplementation is likely to be safe for humans?

Research shows that ketone drinks, such as the Kenetik Ketone Drink, are generally safe for most people. These drinks provide energy and contain pure ketones, which the body can use as fuel.

Although specific studies on the Kenetik Ketone Drink's side effects are lacking, similar products are usually safe when used as directed. Some individuals might experience mild side effects like an upset stomach or nausea.

For those considering joining a trial with this drink, it's important to know that this is not a new product type. Similar ketone supplements have been available and are generally considered safe for most people. Always consult a doctor if there are concerns about potential effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Kenetik Ketone Drink is unique because it introduces a new approach for addressing eating disorders by using ketone supplementation. Unlike traditional treatments that often focus on psychological therapy or medications that alter neurotransmitter levels, this drink supplies the body with ketones, which are alternative energy sources that may influence brain metabolism directly. Researchers are excited about this treatment because it has the potential to provide rapid effects by altering brain energy dynamics, offering a novel angle on symptom management that could complement or enhance existing therapies.

What evidence suggests that ketone supplementation might be an effective treatment for eating disorders?

Research suggests that ketone supplements might help with behaviors related to eating disorders. In this trial, participants will receive the Kenetik Ketone Drink as a form of ketone supplementation. Studies have found that these supplements can reduce cravings and consumption, particularly in cases like alcohol use, which might indicate potential benefits for eating habits as well. Ketones are also known to boost brain activity, potentially improving mood and reducing anxiety—important factors in managing anorexia and bulimia. Although direct data on eating disorders remains limited, these findings provide a hopeful basis for potential benefits in this area. ^{3 6 7 8 9}

Who Is on the Research Team?

Guido Frank, MD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with an eating disorder (Anorexia, Bulimia, or OSFED).

Be medically stable as assessed by a comprehensive medical and behavioral evaluation conducted by a study physician

English as primary spoken language

Exclusion Criteria

Psychotic illness/other organic brain syndromes, dementia, somatization disorders or conversion disorders

I have a condition like diabetes or am pregnant, affecting my eating or weight.

Indication of intellectual disability or autism spectrum disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline EEG Assessment

Participants undergo EEG on two consecutive days after ingestion of ketone supplement or placebo

2 days

2 visits (in-person)

Treatment

Participants receive ketone supplementation drink twice daily for two weeks

2 weeks

Daily self-administration

Follow-up

Participants are monitored for changes in eating disorder symptoms and body mass index

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Kenetik Ketone Drink

Trial Overview 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.

How Is the Trial Designed?

Group I: Ketone Supplementation Experimental Treatment 1 Intervention

Subjects will ingest 2 daily doses of Kenetik ketone drink supplementation for 14 days.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

The study provides 23 consensus-based recommendations for safely and effectively administering ketogenic diet parenteral nutrition (KD-PN) in emergency situations, emphasizing careful monitoring and evaluation of risks and benefits.

KD-PN should be initiated in an intensive care unit and started gradually to minimize complications, with a focus on transitioning back to enteral feeding as soon as it is appropriate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal clinical management of children receiving ketogenic parenteral nutrition: a clinical practice guide. van der Louw, E., Aldaz, V., Harvey, J., et al.[2021]

Oral administration of exogenous ketone supplements over 28 days effectively induced sustained nutritional ketosis in male rats, achieving ketone levels greater than 0.5 mM without the need for carbohydrate restriction.

The study showed that these supplements led to a rapid increase in β-hydroxybutyrate (βHB) levels and a decrease in blood glucose, while having minimal impact on lipid levels, indicating their potential safety and efficacy for therapeutic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exogenous ketone supplementation on blood ketone, glucose, triglyceride, and lipoprotein levels in Sprague-Dawley rats. Kesl, SL., Poff, AM., Ward, NP., et al.[2020]

The ketogenic diet (KD) is highly effective for infants under 1.5 years with epilepsy, showing a higher rate of seizure freedom compared to older children, with 34.5% of infants becoming seizure-free at 3 months versus 19% in older children.

The KD was well tolerated in infants, with no significant safety concerns, and acceptance of the diet was better in infants before they started solid foods, suggesting that early implementation of the KD may be beneficial for managing epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ketogenic diet in infants--Advantages of early use. Dressler, A., Trimmel-Schwahofer, P., Reithofer, E., et al.[2022]

A one-day ketogenic diet significantly increased total energy expenditure by about 110 calories compared to an isocaloric control diet, suggesting it may help with energy balance.

Supplementation with exogenous ketone salts did not enhance energy expenditure or appetite regulation compared to the isocaloric control diet, indicating that they may not provide additional benefits in energy balance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of one-day fasting, ketogenic diet or exogenous ketones on control of energy balance in healthy participants. Hägele, FA., Dörner, R., Koop, J., et al.[2023]

Exogenous ketone drinks, such as ketone esters and ketone salts, effectively raise blood D-β-hydroxybutyrate (D-βHB) levels, with significant increases observed in a study of 15 participants, indicating a practical alternative to traditional ketogenic diets.

Both types of ketone drinks lowered blood glucose and triglyceride levels without causing adverse effects on blood electrolytes, suggesting they are safe and beneficial for metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On the Metabolism of Exogenous Ketones in Humans. Stubbs, BJ., Cox, PJ., Evans, RD., et al.[2022]

This study involves 30 adolescents and young adults with eating disorders, specifically those characterized by purging behaviors, and aims to evaluate the effectiveness of oral naltrexone over six weeks compared to a placebo.

The researchers hypothesize that oral naltrexone will lead to greater improvements in body mass index and self-reported eating disorder symptoms, potentially establishing it as a safe and effective treatment option for impulsive-type eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An experimental protocol for a double-blind placebo-controlled evaluation of the effectiveness of oral naltrexone in management of adolescent eating disorders. Roden, RC., Billman, M., Lane-Loney, S., et al.[2023]

In a 28-day study involving 59 healthy adults, the novel exogenous ketone diester bis-hexanoyl-(R)-1,3-butanediol (BH-BD) was found to be well-tolerated and safe, with no significant differences in tolerability scores compared to a placebo.

BH-BD effectively increased blood ketone levels one hour after consumption, indicating its potential for promoting nutritional ketosis without adverse effects on vital signs or laboratory measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and Safety of a Novel Ketogenic Ester, Bis-Hexanoyl (R)-1,3-Butanediol: A Randomized Controlled Trial in Healthy Adults. Chen, O., Blonquist, TM., Mah, E., et al.[2021]

A diet with 30% energy from the ketone ester BD-AcAc2 led to a significant 12% reduction in energy intake compared to the control group, resulting in lower body weight and fat mass in mice.

Diets with 20% and 25% energy from BD-AcAc2 also reduced body weight and fat mass without affecting energy intake or expenditure, suggesting that these concentrations can effectively promote weight loss independently of calorie consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concentration-Dependent Effects of a Dietary Ketone Ester on Components of Energy Balance in Mice. Deemer, SE., Davis, RAH., Gower, BA., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05507008?term=AREA%5BConditionSearch%5D(Bulimia%20Nervosa)%20AND%20AREA%5BOverallStatus%5D(ACTIVE_NOT_RECRUITING)&rank=1

NCT05507008 | Ketone Supplementation in Eating Disorders This study will investigate the effects of ketone supplementation on eating behavior including drive to binge eat or restrict, mood and anxiety in individuals ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05507008/ketone-supplementation-in-eating-disorders

Ketone Supplementation in Eating Disorders This study will investigate the effects of ketone supplementation on eating behavior including drive to binge eat or restrict, ...

3. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT05507008

Ketone Supplementation in Eating Disorders This study will investigate the effects of ketone supplementation on eating behavior including drive to binge eat or restrict, mood and anxiety

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10901540/

Ketone Supplementation Dampens Subjective and ... A high-fat ketogenic diet and ketone supplements (KS) are efficacious in reducing alcohol craving, alcohol consumption, and signs of alcohol withdrawal.

5. drinkkenetik.com drinkkenetik.com/blogs/ketone-benefits/kenetik-ketone-drink-increases-alpha-brain-wave-activity-in-healthy-adults?srsltid=AfmBOoqIVoV0JFY96lcAkAKEV9cvTEZrL4_svS3kX5U4fOzMbowybDfJ

Recent Study Shows Kenetik Increases Brain Activity Ketones improve communication between brain regions and result in increased brain activity and better cognitive acuity.

6. nationaleatingdisorders.org nationaleatingdisorders.org/

NEDA | Eating Disorders Support, Awareness & Recovery Access support, explore resources, join community events, and take a free eating disorders screening—start your recovery journey with NEDA!

7. drinkkenetik.com drinkkenetik.com/products/kenetik-ketones-drink?srsltid=AfmBOorX4atT3C6UkDi6MajMfh4dUxZ1l8EBNt2S8O4cvTG5LIKmJqvQ

Ketones Drink - Exogenous D-BhB (6-Pack) Kenetik is a ketone drink that's better tasting than exogenous ketone supplements. Fuel your life with 12g of premium d-bhb ketones made from plants.

8. amazon.com amazon.com/Kenetik-Nootropic-Ketones-Caffeine-Performance/dp/B0CRJYMFQ5

KENETIK Nootropic Ketone Drink, Ketones for Energy & ... CLEAN ENERGY DRINK: Kenetik redefines clean energy with the first patented blend of pure ketones - your brain and body's preferred source for sustained energy, ...

9. amazon.com amazon.com/KENETIK-Nootropic-Ketones-Caffeine-Performance/dp/B0CRJXHHJ7

Kenetik Nootropic Ketone Drink, Ketones for Energy & ... CLEAN ENERGY DRINK: Kenetik redefines clean energy with the first patented blend of pure ketones - your brain and body's preferred source for sustained energy, ...