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

Not Applicable

Completed

• Conditions: Exogenous Ketosis
• Interventions: Dietary Supplement: KE1 10g; Dietary Supplement: KE4 5g; Dietary Supplement: KE1 5g; Other: Placebo drink; Dietary Supplement: KE 10g

• Registration Number: NCT05390385
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Study Timeline

• Study First Submitted: 2022-05-13
• Study First Submitted QC: 2022-05-22
• Study First Posted: 2022-05-25
• Study Start: 2022-09-23
• Status Verified: 2023-08
• Primary Completion: 2023-08-15
• Study Completion: 2023-08-15
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
KE1 10g	KE1 10g	-
KE4 5g	KE4 5g	-
KE1 5g	KE1 5g	-
Control placebo	Placebo drink	-
KE4 10g	KE 10g	-

Primary Outcome Measures

Name	Time	Method
Capillary beta-hydroxybutyrate concentrations	2 hours	Exogenous ketone supplements are now widely available at the commercial level, so it is important to understand the concentration-dependent effects of these supplements on circulating ketone concentrations, measured by concentrations of beta-hydroxybutyrate following a capillary blood fingerstick.
Supplement tolerability and acceptability	2 hours	The ketone supplements being used have been described as having strong, disagreeable flavors. Therefore, the first outcome measure will be understanding how the flavors and gastrointestinal effects of both supplements may impact subjects. This outcome measure will be assessed by measuring the symptoms experienced, the time at which each symptom occurred, and the duration of each symptom using a scaled symptom questionnaire titled "Symptom Questionnaire." The questionnaire rates symptoms on an ordinal scale from absent, mild, moderate, to severe, with absent being the minimum value and better outcome, and severe being the maximum value and worst outcome. The questionnaire will assess the time that each symptom occurred, on a scale from immediately, one hour, and two hours after supplement consumption. The questionnaire will assess the duration of each symptom, on a scale of less than thirty minutes, one hour, and two hours after each symptom occurred.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States