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Tolerance and Safety of a Ketone-Promoting Food Ingredient

NCT04707989 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-05-10

No results posted yet for this study

Summary

The objective of this study is to capture information on tolerance and safety of a ketone-promoting food ingredient in healthy adults.

Conditions

  • Tolerance

Interventions

OTHER

Ketone- Promoting Food Ingredient #1

Novel proprietary food ingredient (#1) that contains precursors to naturally occurring energy molecules called ketone bodies. Promotes mildly elevated blood ketone concentrations. Mixed into a beverage.

OTHER

Ketone- Promoting Food Ingredient #2

Previously characterized proprietary food ingredient (#2) that contains precursors to naturally occurring energy molecules called ketone bodies. Promotes mildly elevated blood ketone concentrations. Mixed into a beverage.

OTHER

Ketone Free Placebo

Beverage that is matched to ketone-promoting food ingredient #1 beverage for appearance, taste, texture and volume. Does not contain ketones or ketone precursors.

Sponsors & Collaborators

  • BHB Therapeutics, Ireland LTD

    lead INDUSTRY

Principal Investigators

  • Dawn Beckman, MD · BioFortis

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-11
Primary Completion
2021-03-05
Completion
2021-03-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04707989 on ClinicalTrials.gov