NCT05390385

Acceptability and Tolerability of Ketone Supplements and Effects of BHB Concentrations in Young Adults

Acceptability and Tolerability of Ketone Supplements and Their Effects on Capillary Beta-hydroxybutyrate Concentrations in Young Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

Summary

Assess the acceptability and tolerability of two different commercially available ketone supplements and determine their effects on capillary blood concentrations of the ketone beta-hydroxybutyrate and glucose in young adults.

Detailed description

Past findings suggest that raising ketone concentrations through the use of a ketogenic diet (high-fat, moderate-protein, low-carbohydrate) is effective for preventing weight gain and decreasing appetite. However, strict adherence to this diet is difficult, and ending the diet can result in the regaining of body weight. Our group has investigated the effects of various ketone supplements in both rodents and humans. Past results of our group and that of our colleagues suggest that ketone supplements have the ability to increase ketone concentrations in the blood, decrease appetite, lower body weight, and maintain lean body mass. Exogenous ketones may serve as an alternative to the ketogenic diet by increasing concentrations of ketones without the need for adherence to a strict diet. However, little is known about ketone supplements as it relates to their tolerability and efficacy. For example, the taste of these supplements is unacceptable to some individuals and it is unclear if ketone supplements provide an adequate approach to raise and maintain circulating ketone concentrations as observed with the ketogenic diet. This information will be valuable before launching larger-scale human trials. Ketone supplements (KE1 and KE4) will be obtained from KetoneAid (Falls Church, VA). Participants will be asked to drink (5g and 10g) of each supplement separated by at least 3 days. Capillary blood samples will be measured using a handheld device to measure circulating beta-hydroxybutyrate (BHB) and glucose concentrations while a questionnaire will be used to assess the acceptability and tolerability of the ketone supplements.

Conditions

• Exogenous Ketosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	KE1 5g	5g of KE1 (KetoneAid, Falls Church, VA), diluted to 4 ounces
DIETARY_SUPPLEMENT	KE1 10g	10g of KE1 (KetoneAid, Falls Church, VA), equal to 4 ounces
DIETARY_SUPPLEMENT	KE4 5g	5g of KE4 (KetoneAid, Falls Church, VA), diluted to 4 ounces
DIETARY_SUPPLEMENT	KE 10g	10g of KE4 (KetoneAid, Falls Church, VA), diluted to 4 ounces
OTHER	Placebo drink	Flavor-matched control placebo drink (KetoneAid, Falls Church, VA), 4 ounces

Timeline

• Start date: 2022-09-23
• Primary completion: 2023-08-15
• Completion: 2023-08-15
• First posted: 2022-05-25
• Last updated: 2023-08-16

Locations

1 site across 1 country: United States