Acceptability and Tolerability of Ketone Supplements and Effects of BHB Concentrations in Young Adults
Condition: Exogenous Ketosis
MeSH terms: Ketosis
Study type: Interventional

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.
    

Intervention name(s): KE1 5g; KE1 10g; KE4 5g; KE 10g; Placebo drink
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): 5g of KE1 (KetoneAid, Falls Church, VA), diluted to 4 ounces; 10g of KE1 (KetoneAid, Falls Church, VA), equal to 4 ounces; 5g of KE4 (KetoneAid, Falls Church, VA), diluted to 4 ounces; 10g of KE4 (KetoneAid, Falls Church, VA), diluted to 4 ounces; Flavor-matched control placebo drink (KetoneAid, Falls Church, VA), 4 ounces
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.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: exogenous ketones; ketone supplementation; ketone monoester; ketone salt; tolerability; acceptability; beta-hydroxybutyrate