NCT04707989

Tolerance and Safety of a Ketone-Promoting Food Ingredient

A Randomized, Placebo Controlled, Study to Evaluate the Tolerance and Safety of a Ketone- Promoting Food Ingredient in Healthy Men and Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: BHB Therapeutics, Ireland LTD · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-12-11
• Primary completion: 2021-03-05
• Completion: 2021-03-05
• First posted: 2021-01-13
• Last updated: 2021-05-10

Locations

1 site across 1 country: United States