Exogenous Ketosis
Conditions
Keywords
Exogenous ketosis, Beta-hydroxybutyrate, Safety, Tolerability, Ketone bodies
Brief summary
The goal of this clinical trial is to evaluate the safety and tolerability of free beta-hydroxybutyrate induced ketosis in healthy individuals. The main question it aims to answer is: * Is free beta-hydroxybutyrate safe and well tolerated by adults? Participants will be asked to ingest 10 grams of beta-hydroxybutyrate, diluted in water and sweetened with Stevia, every morning between 9:00 and 11:00 for four weeks.
Detailed description
Several ketogenic interventions have shown benefits in a wide variety of clinical scenarios. Ketosis can be induced in different ways: by 72 hours of fasting, with a carbohydrate-restricted diet and with supplements. For emergency situations, such as heart failure, the first two options are not an option for patients as they cannot wait 72 hours. There are 3 safe supplements for inducing ketosis: ketone salts, ketone esters and medium-chain triglycerides. Even though they all raise the beta-hydroxybutyrate serum concentration, they significantly differ in safety profiles, drug vehicles, palatability and monetary costs. A biologically identical beta-hydroxybutyrate supplement with prompt onset of action and free of salt, alcohol and drug vehicles would be an adequate option in many clinical settings. A gender and age-balanced adult sample will be recruited in order to evaluate the safety and tolerability of free beta-hydroxybutyrate. Participants will be asked to ingest 10 grams of beta-hydroxybutyrate, diluted in water and sweetened with Stevia, every morning between 9:00 and 11:00 for four weeks. Symptoms will be evaluated on a daily basis with a self-administered opened questionnaire. A venous blood gas analysis will be made at the beginning, 2 and 4 weeks later.
Interventions
DIETARY_SUPPLEMENTFree Beta-hydroxybutyrate
Participants will be asked to ingest 10 grams of beta-hydroxybutyrate, diluted in water and sweetened with Stevia, every morning between 9:00 and 11:00 for four weeks.
Sponsors
American Ketone LLC
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Asymptomatic adults who have not been diagnosed with chronic degenerative diseases or diseases that cause acid-base imbalances. * Regarding women of childbearing age, it will only be recruited those who are using a method of contraception including oral contraception, contraceptive implant, contraceptive injection, intrauterine device (IUD) or patch. * Adults without cognitive impairment that can compromise decision making.
Exclusion criteria
* Scheduled surgery during participation period. * Adults on a ketogenic diet, carbohydrate-restricted diet or intermittent fasting. * Women with a positive HCG serum or urine pregnancy test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms | 4 weeks | Frequency and severity of symptoms assessed by a self-administered questionnaire |
| Venous blood gas analysis | 4 weeks | Analysis of pH, HCO3, CO2 and electrolytes to rule out disorders of acid-base balance |
Countries
Mexico
Contacts
Primary ContactAdrian Soto, PhD, MD.
Backup ContactLisa Pimentel, MD
Outcome results
None listed