Ketone Ester and Gut Microbiome Study
This study is looking at how a dietary supplement called Bis-octanoyl-(R)-1,3-butanediol (C8) affects the bacteria in your gut, known as the microbiome. Researchers want to see if this ketone ester can reduce signs of aging in the gut microbiome and what other changes might occur. They will measure changes in your microbiome composition over 21 days. You might be able to join if you are a healthy adult between 18 and 40 years old with a BMI between 18.5 and 39.9. The study plans to enroll 20 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study planning to enroll 20 healthy adults to see how a ketone ester affects their gut microbiome.
- What's involved
- You will take a ketone ester daily for 7 days, collect and ship stool samples, measure ketone levels with urine strips, answer diet questions, and record any symptoms.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your microbiome will be measured from baseline to the end of the 21-day study period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06954675
Comparison of Microbiome Changes in Healthy Adults Following Ketone Ester Consumption
Recruiting
NAAges 18–40InterventionalBasic scienceUniversity of California, San FranciscoInvestigator-initiated
~20 participants
Updated 2026-01-26 on ClinicalTrials.gov
What's tested:Exogenous ketone ester
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Longitudinal Change in Microbiome Composition
Measured over From baseline sampling to final sampling, including intervention period, at 21 days
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- John C Newman, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Subject is male or female, 18 to 40 years of age, inclusive, at Virtual Visit 1.
Subject has a self-reported BMI of 18.5 to 39.9 kg/m2 (inclusive) at Virtual Visit 1.
Subject is willing and able to comply with all study procedures including maintenance of habitual dietary intake, consumption of study product at specified intervals, written questionnaires including study log and beverage tolerability questionnaire (KETQ), habitual exercise and medication and supplement use.
Subject has an email address and internet access via computer, phone, or other device, and is willing and able to maintain internet access throughout the trial to complete virtual visits via video conference.
Subject has no health conditions that would prevent them from fulfilling the study requirements as judged by the Study Clinician on the basis of medical history.
Subject understands the study procedures and signs forms providing informed consent to participate in the study.
Exclusion
Subject is unable to converse in English or Spanish
Subject is unable to provide informed consent due to cognitive impairment or insufficient English or Spanish language comprehension
Subject has been hospitalized within 30 days of Virtual Visit 1.
Subject has a history or presence of uncontrolled and/or clinically active pulmonary, cardiac (e.g. \>= New York Heart Association class III), hepatic, renal, endocrine (including type 1 diabetes), hematologic, immunologic, neurologic (e.g., Alzheimer's or Parkinson's diseases), psychiatric (including unstable depression and/or anxiety disorders) or biliary disorders. Stable chronic disease is not an exclusion criterion unless specified.
Subject has a clinically important gastrointestinal condition that would potentially interfere with the evaluation of the study beverage \[e.g., inflammatory bowel disease, irritable bowel syndrome, chronic constipation, severe constipation (in the opinion of the Study Clinician), history of frequent diarrhea, history of surgery for weight loss, gastroparesis, systemic disease that might affect gut motility according to the Study Clinician, reflux requiring daily medication, history of gastrointestinal ulcers or bleeding, celiac disease, and/or clinically important lactose intolerance\].
Subject has a known allergy, intolerance, or sensitivity to any of the ingredients in the study product, including milk protein.
Subject is undergoing treatment or active surveillance for cancer, or has been diagnosed with cancer in the prior two years, except for non-melanoma skin cancer.
Subject has recently used antibiotics within 60 days of Virtual Visit 1.
Subject has extreme dietary habits (e.g., intermittent fasting or time restricted eating, Atkins diet, vegan, very high protein/low carbohydrate or has used weight-loss medications (including over-the-counter medications and/or supplements) or programs within 30 days of Virtual Visit 1.
Subject has used medications (over-the-counter or prescription) known to influence gastrointestinal function including, but not limited to, opioids, weight loss medications, antidiarrheals, and antispasmodics) within 30 days of Virtual Visit 1.
Subject has used ketone supplements (ketone salts or esters, and medium chain triglycerides \[MCT\]) within 30 days of Virtual Visit 1.
Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded.
Subject has a condition the Study Clinician believes would interfere with their ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.
What this trial measures
- Longitudinal Change in Microbiome CompositionFrom baseline sampling to final sampling, including intervention period, at 21 days
Microbiome composition will be defined as the following components: 1) alpha-diversity as calculated by Shannon Index; 2) beta-diversity; and 3) microbial community taxa and gene number.