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

Study Overview
=================
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.

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

Conditions
-----------------
Exogenous Ketosis

Intervention / Treatment
-----------------
* Dietary Supplement: Free Beta-hydroxybutyrate


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exogenous ketosis<br>Intake of 10 grams of beta-hydroxybutyrate free of alcohol and salt. | Dietary Supplement: Free Beta-hydroxybutyrate<br>* 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.<br>* Other names: BetaFlow Ketone Concentrate;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms | Frequency and severity of symptoms assessed by a self-administered questionnaire | 4 weeks | 
| Venous blood gas analysis | Analysis of pH, HCO3, CO2 and electrolytes to rule out disorders of acid-base balance | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exogenous ketosis, Safety, Beta-hydroxybutyrate, Tolerability, Ketone bodies