Evaluation of the Safety and Tolerability of Exogenous Ketosis Induced by Free Beta-hydroxybutyrate.

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status

Enrolling

Conditions

Exogenous Ketosis

Treatments

Dietary Supplement: Free Beta-hydroxybutyrate

Study type

Interventional

Funder types

Other

Identifiers

NCT05584371

UIE-4275-22-22-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

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.