Exogenous Ketones and Behavior

Last updated: July 26, 2024
Sponsor: German Institute of Human Nutrition
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

ketone ester

dextrose (placebo)

Clinical Study ID

NCT06515717
ExoKet
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The study will examine the effect of exogenous ketone ester on behavior and metabolism using Virtual Reality and computerizes behavioral tasks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Consent to participate

  • Fluent in German

  • Physically healthy. No regular medication

  • No drug use 1 week prior to the study

  • BMI 18-31 kg/m2

Exclusion

Exclusion Criteria:

  • Former or current illnesses of:

  • Brain or mind (including eating disorders, personality disorders, alcohol, drugs ordrug dependence, neurological disorders other than occasional headache; depressionor anxiety disorder excluded)

  • Heart or blood circulation

  • Gastro-intestinal or endocrine disorders

  • Liver or kidney disorders

  • Electrolyte imbalance

  • Other serious past or present medical conditions (for example, metabolic syndrome,diabetes, cancer)

  • Pregnancy

  • Extreme athletes (>2h/day intense work-out; casual cycling or walking is ok)

  • Menopause (post menopause is ok)

  • Ketogenic diet, ketogenic supplement intake, intermittent fasting or calorierestricted diet during preceding 4 weeks of study participation

  • Fear of blood draw

Study Design

Total Participants: 45
Treatment Group(s): 2
Primary Treatment: ketone ester
Phase:
Study Start date:
July 18, 2024
Estimated Completion Date:
June 23, 2025

Study Description

This study investigates the effects of exogenous ketone ester on behavior, cognition, and metabolism over one week of consumption. Using a within-subjects, randomized, crossover design, participants will undergo two phases: one with the ketone ester supplement and one with a calorie- and taste-matched placebo. The study includes four lab visits: visits 1 and 3 mark the first day of each intervention, while visits 2 and 4 mark the last day. During each visit, participants will complete behavioral tasks, questionnaires, and blood tests. Additionally, participants will record their food intake via an app and collect stool samples throughout the intervention.

Connect with a study center

  • German Institute of Human Nutrition

    Potsdam, Brandenburg 14558
    Germany

    Active - Recruiting

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