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

NCT05390385 | Completed

• 1 other identifier: IRB-300009075
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Exogenous Ketosis

Keywords

exogenous ketones; ketone supplementation; ketone monoester; ketone salt; tolerability; acceptability; beta-hydroxybutyrate

Outcome Measures

Primary Outcomes (2)

• Supplement tolerability and acceptability

  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.

  2 hours

• Capillary beta-hydroxybutyrate concentrations

  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.

  2 hours

Study Arms (5)

Control placebo

PLACEBO COMPARATOR

Other: Placebo drink

KE1 5g

EXPERIMENTAL

Dietary Supplement: KE1 5g

KE1 10g

EXPERIMENTAL

Dietary Supplement: KE1 10g

KE4 5g

EXPERIMENTAL

Dietary Supplement: KE4 5g

KE4 10g

EXPERIMENTAL

Dietary Supplement: KE 10g

Interventions

KE1 5g DIETARY_SUPPLEMENT

5g of KE1 (KetoneAid, Falls Church, VA), diluted to 4 ounces

KE1 5g

KE1 10g DIETARY_SUPPLEMENT

10g of KE1 (KetoneAid, Falls Church, VA), equal to 4 ounces

KE1 10g

KE4 5g DIETARY_SUPPLEMENT

5g of KE4 (KetoneAid, Falls Church, VA), diluted to 4 ounces

KE4 5g

KE 10g DIETARY_SUPPLEMENT

10g of KE4 (KetoneAid, Falls Church, VA), diluted to 4 ounces

KE4 10g

Placebo drink OTHER

Flavor-matched control placebo drink (KetoneAid, Falls Church, VA), 4 ounces

Control placebo

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• 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.

  PMID: 29163194 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairperson of the Department of Human Studies and Associate Professor of Exercise Physiology

Model Details: 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.

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 25, 2022
• Study Start: September 23, 2022
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: August 16, 2023

Record last verified: 2023-08

Locations

US (1)