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

The University of Alabama at Birmingham logo

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

Trial contacts and locations

1

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Central trial contact

Michaela L Bolyard, BS; Eric P Plaisance, PhD

Data sourced from clinicaltrials.gov

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