RECRUITING

Comparison of Microbiome Changes in Healthy Adults Following Ketone Ester Consumption

Conditions

Microbiome Analysis Microbiome Exogenous ketone Ketone ester

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this observational study is to learn if a ketone ester can improve the content of the gut microbiome. The main questions it aims to answer are: * Does a ketone ester reduce age-related signatures in the gut microbiome? * What changes occur in the gut microbiome after consuming a ketone ester? Participants will: * Take a ketone ester every day for seven (7) days * Collect and ship stool samples within seven (7) days before, during, and within seven (7) days after the study period * Measure their ketone levels with a urine strip every day after having the drink * Answer questions about their typical diet on a normal day * Record their symptoms, if any arise

Official Title

Bacterial Responses to Enteric Alterations After Ketones

Quick Facts

Study Start:2025-10-10

Study Completion:2026-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06954675

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* 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.

* 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.

Contacts and Locations

Study Contact

Sidharth S Madhavan, PhD

CONTACT

248-797-1025

sidharth.madhavan@ucsf.edu

John C Newman, MD, PhD

CONTACT

415-502-5134

Newman@ucsf.edu

Principal Investigator

John C Newman, MD, PhD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

UCSF Wayne and Gladys Valley Center for Vision

San Francisco, California, 94158

United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

John C Newman, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-10-10

Study Completion Date2026-09-30

Study Record Updates

Study Start Date2025-10-10

Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

Microbiome
Exogenous ketone
Ketone ester

Additional Relevant MeSH Terms

Microbiome Analysis