Exogenous Ketones and Behavior

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-18

Study Completion Date

2025-06-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity in Healthy Subjects

NCT05980858

Ketosis Ketonemia

COMPLETED NA

Exogenous Ketosis in a Fed and a Fasted State

NCT06320522

Ketosis Exogenous Ketosis

RECRUITING NA

Effects of Ketone Monoesters on Brain Function

NCT06395051

Brain Insulin Sensitivity Brain Vascular Function Cerebral Blood Flow +2 more

COMPLETED NA

Ketone Dose and Cerebral Blood Flow Study

NCT06032156

Cerebrovascular Function Cognition

RECRUITING NA

KetoNiFast: Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting

NCT06535815

Nutrition Muscle Loss Inflammatory Response

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Behavior

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ketone ester

Participants consume a ketone ester 3x per day for 8 days.

Group Type EXPERIMENTAL

ketone ester

Intervention Type DIETARY_SUPPLEMENT

oral supplement

Placebo containing dextrose

Participants consume a placebo 3x per day for 8 days. The placebo is matched in calories and taste to the ketone ester.

Group Type PLACEBO_COMPARATOR

dextrose (placebo)

Intervention Type DIETARY_SUPPLEMENT

oral supplement calorie and taste matched to ketone supplement

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ketone ester

oral supplement

Intervention Type DIETARY_SUPPLEMENT

dextrose (placebo)

oral supplement calorie and taste matched to ketone supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 Criteria

* Former or current illnesses of:
* Brain or mind (including eating disorders, personality disorders, alcohol, drugs or drug dependence, neurological disorders other than occasional headache; depression or 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 calorie restricted diet during preceding 4 weeks of study participation
* Fear of blood draw

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes