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

The University of Alabama at Birmingham

Status: Completed

Conditions: Exogenous Ketosis

Treatments: Other: Placebo drink; Dietary Supplement: KE1 5g; Dietary Supplement: KE1 10g; Dietary Supplement: KE4 5g; Dietary Supplement: KE 10g

Study type: Interventional

Funder types: Other

Identifiers

NCT05390385

IRB-300009075

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult 18-25 years of age
• In generally good health
• Able and willing to attend study visits (once every 3 days for ~2 weeks)
• BMI 18.5-29.9

Exclusion criteria

• Pregnant
• Has preexisting medical conditions, including Type 2 diabetes, heart disease, or cancer
• BMI ≥ 30

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

14 participants in 5 patient groups, including a placebo group

Control placebo

Placebo Comparator group

Treatment:

Other: Placebo drink

KE1 5g

Experimental group

Treatment:

Dietary Supplement: KE1 5g

KE1 10g

Experimental group

Treatment:

Dietary Supplement: KE1 10g

KE4 5g

Experimental group

Treatment:

Dietary Supplement: KE4 5g

KE4 10g

Experimental group

Treatment:

Dietary Supplement: KE 10g