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

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05390385

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Exogenous Ketosis	Dietary Supplement: KE1 5g Dietary Supplement: KE1 10g Dietary Supplement: KE4 5g Dietary Supplement: KE 10g Other: Placebo drink	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Participants will each undergo all five treatments, in randomized order. The five treatments include the control placebo, 5g of KE1, 10g of KE1, 5g of KE4, and 10g of KE4. There will be a minimum of two days washout period between treatments.Participants will each undergo all five treatments, in randomized order. The five treatments include the control placebo, 5g of KE1, 10g of KE1, 5g of KE4, and 10g of KE4. There will be a minimum of two days washout period between treatments.

Masking:

Double (Participant, Investigator)

Masking Description:

Supplement packaging will be labeled with an alphanumeric code that is only understood by an individual who is not involved in the study. The participants and study team will both be blinded to the supplement being given.

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control placebo	Other: Placebo drink Flavor-matched control placebo drink (KetoneAid, Falls Church, VA), 4 ounces
Experimental: KE1 5g	Dietary Supplement: KE1 5g 5g of KE1 (KetoneAid, Falls Church, VA), diluted to 4 ounces
Experimental: KE1 10g	Dietary Supplement: KE1 10g 10g of KE1 (KetoneAid, Falls Church, VA), equal to 4 ounces
Experimental: KE4 5g	Dietary Supplement: KE4 5g 5g of KE4 (KetoneAid, Falls Church, VA), diluted to 4 ounces
Experimental: KE4 10g	Dietary Supplement: KE 10g 10g of KE4 (KetoneAid, Falls Church, VA), diluted to 4 ounces

Outcome Measures

Primary Outcome Measures

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Stubbs BJ, Cox PJ, Evans RD, Santer P, Miller JJ, Faull OK, Magor-Elliott S, Hiyama S, Stirling M, Clarke K. On the Metabolism of Exogenous Ketones in Humans. Front Physiol. 2017 Oct 30;8:848. doi: 10.3389/fphys.2017.00848. eCollection 2017.

Responsible Party:

Eric P. Plaisance, Chairperson of the Department of Human Studies and Associate Professor of Exercise Physiology, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT05390385

Other Study ID Numbers:

IRB-300009075

First Posted:

May 25, 2022

Last Update Posted:

Aug 16, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Eric P. Plaisance, Chairperson of the Department of Human Studies and Associate Professor of Exercise Physiology, University of Alabama at Birmingham

exogenous ketones

ketone supplementation

Additional relevant MeSH terms:

Ketosis

Study Results

No Results Posted as of Aug 16, 2022