NCT05584371

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 18, 2022

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

October 3, 2022

Last Update Submit

October 14, 2022

Conditions

Exogenous Ketosis

Keywords

Exogenous ketosisBeta-hydroxybutyrateSafetyTolerabilityKetone bodies

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Exogenous ketosis

EXPERIMENTAL

Intake of 10 grams of beta-hydroxybutyrate free of alcohol and salt.

Dietary Supplement: Free Beta-hydroxybutyrate

Interventions

Free Beta-hydroxybutyrateDIETARY_SUPPLEMENT

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.

Also known as: BetaFlow Ketone Concentrate
Exogenous ketosis

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INCMNSZ

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Related Publications (10)

  • Abe S, Ezaki O, Suzuki M. Medium-chain triglycerides (8:0 and 10:0) are promising nutrients for sarcopenia: a randomized controlled trial. Am J Clin Nutr. 2019 Sep 1;110(3):652-665. doi: 10.1093/ajcn/nqz138.

    PMID: 31334544BACKGROUND

  • American Ketone. (n.d.). Therapeutic Ketosis = Potential for New Outcomes. Retrieved June 6, 2022, from https://americanketone.com

    BACKGROUND

  • Fortier M, Castellano CA, Croteau E, Langlois F, Bocti C, St-Pierre V, Vandenberghe C, Bernier M, Roy M, Descoteaux M, Whittingstall K, Lepage M, Turcotte EE, Fulop T, Cunnane SC. A ketogenic drink improves brain energy and some measures of cognition in mild cognitive impairment. Alzheimers Dement. 2019 May;15(5):625-634. doi: 10.1016/j.jalz.2018.12.017. Epub 2019 Apr 23.

    PMID: 31027873BACKGROUND

  • Holland, A. M., Qazi, A. S., Beasley, K. N., & Bennett, H. R. (2019). Blood and cardiovascular health parameters after supplementing with ketone salts for six weeks. Journal of Insulin Resistance, 4(1), 7. https://doi.org/10.4102/jir.v4i1.47

    BACKGROUND

  • Nielsen R, Moller N, Gormsen LC, Tolbod LP, Hansson NH, Sorensen J, Harms HJ, Frokiaer J, Eiskjaer H, Jespersen NR, Mellemkjaer S, Lassen TR, Pryds K, Botker HE, Wiggers H. Cardiovascular Effects of Treatment With the Ketone Body 3-Hydroxybutyrate in Chronic Heart Failure Patients. Circulation. 2019 Apr 30;139(18):2129-2141. doi: 10.1161/CIRCULATIONAHA.118.036459.

    PMID: 30884964BACKGROUND

  • Soto-Mota A, Norwitz NG, Clarke K. Why a d-beta-hydroxybutyrate monoester? Biochem Soc Trans. 2020 Feb 28;48(1):51-59. doi: 10.1042/BST20190240.

    PMID: 32096539BACKGROUND

  • Soto-Mota A, Norwitz NG, Evans R, Clarke K, Barber TM. Exogenous ketosis in patients with type 2 diabetes: Safety, tolerability and effect on glycaemic control. Endocrinol Diabetes Metab. 2021 May 20;4(3):e00264. doi: 10.1002/edm2.264. eCollection 2021 Jul.

    PMID: 34277987BACKGROUND

  • Soto-Mota A, Vansant H, Evans RD, Clarke K. Safety and tolerability of sustained exogenous ketosis using ketone monoester drinks for 28 days in healthy adults. Regul Toxicol Pharmacol. 2019 Dec;109:104506. doi: 10.1016/j.yrtph.2019.104506. Epub 2019 Oct 23.

    PMID: 31655093BACKGROUND

  • St-Onge MP, Jones PJ. Physiological effects of medium-chain triglycerides: potential agents in the prevention of obesity. J Nutr. 2002 Mar;132(3):329-32. doi: 10.1093/jn/132.3.329.

    PMID: 11880549BACKGROUND

  • Stubbs BJ, Cox PJ, Kirk T, Evans RD, Clarke K. Gastrointestinal Effects of Exogenous Ketone Drinks are Infrequent, Mild, and Vary According to Ketone Compound and Dose. Int J Sport Nutr Exerc Metab. 2019 Nov 1;29(6):596-603. doi: 10.1123/ijsnem.2019-0014.

    PMID: 31034254BACKGROUND

Study Officials

  • Adrian Soto, PhD, MD.

    INCMNSZ

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrian Soto, PhD, MD.

CONTACT

5572191248adrian.sotom@incmnsz.mx

Lisa Pimentel, MD

CONTACT

5554870900lisa4pimentel@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2022

First Posted

October 18, 2022

Study Start

October 1, 2022

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

October 18, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

Upon request to PI

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
One year after publication
Access Criteria
Send email to adrian.sotom@incmnsz.mx

Locations

ME(1)