Actively Recruiting
Bacterial Responses to Enteric Alterations After Ketones
Led by University of California, San Francisco · Updated on 2026-01-26
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand whether consuming a ketone ester can improve the gut microbiome in healthy adults aged 18 to 40 years. The study focuses on whether the ketone ester reduces age-related changes in the gut microbiome and identifies specific changes that occur after taking the ketone ester. Participants in this study are healthy volunteers without major gastrointestinal or chronic health issues that could interfere with the study. Participants will take 25 grams of the ketone ester bis-octanoyl-(R)-1,3-butanediol (C8) daily for seven days. During this time, they will collect stool samples before, during, and after the intervention to analyze microbiome changes over a 21-day period. Participants will also measure their ketone levels daily using urine test strips and answer questions about their usual diet and any symptoms experienced while taking the ketone ester. Throughout the study, participants will complete virtual visits using video conferencing and maintain internet access for communication and questionnaires. They will record their diet, symptoms related to the study product, and provide stool samples for microbiome analysis. The primary outcome is the change in microbiome composition over the 21-day study period, with secondary outcomes focusing on the tolerability of the ketone ester. The total participation time includes the 7-day intervention and follow-up assessments.
CONDITIONS
Brief Title
Comparison of Microbiome Changes in Healthy Adults Following Ketone Ester Consumption
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female between 18 and 40 years old at Virtual Visit 1
- Self-reported body mass index (BMI) between 18.5 and 39.9 kg/m2 at Virtual Visit 1
- Willing and able to follow all study procedures, including maintaining usual diet and exercise
- Willing and able to consume the study product as specified and complete questionnaires
- Has email and internet access via computer, phone, or other device for virtual visits
- No health conditions preventing study participation as judged by the Study Clinician
- Understands study procedures and provides informed consent
You will not qualify if you...
- Unable to converse in English or Spanish
- Unable to provide informed consent due to cognitive impairment or language barriers
- Hospitalized within 30 days before Virtual Visit 1
- History or presence of uncontrolled or active severe pulmonary, cardiac, hepatic, renal, endocrine, hematologic, immunologic, neurologic, psychiatric, or biliary disorders
- Clinically important gastrointestinal conditions affecting evaluation of the study beverage
- Known allergy or sensitivity to study product ingredients, including milk protein
- Undergoing cancer treatment or diagnosed with cancer within past two years except non-melanoma skin cancer
- Use of antibiotics within 60 days before Virtual Visit 1
- Extreme dietary habits or recent use of weight-loss medications or programs within 30 days
- Use of medications affecting gastrointestinal function within 30 days
- Use of ketone supplements within 30 days
- Female who is pregnant, planning pregnancy, lactating, or unwilling to use contraception during study
- Any condition judged by Study Clinician to interfere with consent, compliance, study results, or participant safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 virtual visit
Duration - 7 days
Participants consume 25g of the ketone ester bis-octanoyl-(R)-1,3-butanediol (C8) daily while maintaining usual diet and exercise.
Daily virtual check-ins during the intervention period
Duration - Up to 21 days including intervention
Participants are observed for longitudinal changes in microbiome composition after the intervention period.
Approximately 3 sampling visits
Trial Site Locations
Total: 1 location
1
UCSF Wayne and Gladys Valley Center for Vision
San Francisco, California, United States, 94158
Actively Recruiting
Research Team
S
Sidharth S Madhavan, PhD
J
John C Newman, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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