Evaluation of the Safety and Tolerability of Exogenous Ketosis Induced by Free Beta-hydroxybutyrate.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Venous blood gas analysis
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Venous blood gas analysis
Time Frame: 4 weeks
Analysis of pH, HCO3, CO2 and electrolytes to rule out disorders of acid-base balance
Symptoms
Time Frame: 4 weeks
Frequency and severity of symptoms assessed by a self-administered questionnaire
Secondary Outcomes
No secondary outcomes reported