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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will investigate the effects of ketone supplementation on eating behavior including drive to binge eat or restrict, mood and anxiety in individuals with anorexia or bulimia nervosa. In addition, the investigators will contrast the effects of active ketone supplementation versus placebo on electroencephalogram (EEG) measurement. All subjects enrolled in the study will undergo EEG on two consecutive days at the beginning of the study, after active ketone supplementation or placebo drink, matched in taste to the ketone drink. Days will be randomized. Thereafter, all subjects will take the ketone supplementation drink for two weeks, twice daily.

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.

What data supports the effectiveness of the Kenetik Ketone Drink treatment for eating disorders?

Research on similar treatments, like the ketogenic diet combined with ketamine, shows potential benefits for anorexia nervosa, suggesting that ketone-based approaches might help with eating disorders. However, more research is needed to confirm these effects specifically for the Kenetik Ketone Drink. ^{1 2 3 4 5}

Is ketone supplementation safe for humans?

A study on a ketone supplement called bis-hexanoyl-(R)-1,3-butanediol (BH-BD) found it to be safe and well-tolerated in healthy adults over 28 days, with no significant changes in vital signs or lab tests. ^{6 7 8 9 10}

How does the Kenetik Ketone Drink treatment differ from other treatments for eating disorders?

The Kenetik Ketone Drink is unique because it provides exogenous ketones, which can induce ketosis without the need for a strict ketogenic diet. This approach may help regulate energy metabolism and appetite, offering a novel way to manage eating disorders compared to traditional dietary or medication-based treatments. ^{11 12 13 14 15}

Research Team

Guido Frank, MD

Principal Investigator

University of California, San Diego

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Ketogenic diet and ketamine infusion treatment to target chronic persistent eating disorder psychopathology in anorexia nervosa: a pilot study. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Reply to Skokou, M. Comment on "Keeler et al. Ketamine as a Treatment for Anorexia Nervosa: A Narrative Review. Nutrients 2021, 13, 4158". [2022]

3. United States 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. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Ketamine as a Novel Psychopharmacotherapy for Eating Disorders: Evidence and Future Directions. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Synergy between ketamine and ketogenic diet in anorexia nervosa, and other neurobehavioral disorders. [2023]

6. Switzerland 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. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Concentration-Dependent Effects of a Dietary Ketone Ester on Components of Energy Balance in Mice. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

The ketogenic diet in infants--Advantages of early use. [2022]

9. Denmark pubmed.ncbi.nlm.nih.gov

Ketogenic diet effects on cognition, mood, and psychosocial adjustment in children. [2017]

10. England pubmed.ncbi.nlm.nih.gov

Hypothalamic sensing of ketone bodies after prolonged cerebral exposure leads to metabolic control dysregulation. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Impact of one-day fasting, ketogenic diet or exogenous ketones on control of energy balance in healthy participants. [2023]

12. Switzerland pubmed.ncbi.nlm.nih.gov

On the Metabolism of Exogenous Ketones in Humans. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Optimal clinical management of children receiving ketogenic parenteral nutrition: a clinical practice guide. [2021]

14. England pubmed.ncbi.nlm.nih.gov

Effects of exogenous ketone supplementation on blood ketone, glucose, triglyceride, and lipoprotein levels in Sprague-Dawley rats. [2020]

15. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and role of ketogenic parenteral nutrition for intractable childhood epilepsy. [2017]