NCT05584371

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Exogenous Ketosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-10-01
• Completion: 2023-12-01
• First posted: 2022-10-18
• Last updated: 2022-10-18

Locations

1 site across 1 country: Mexico