Summary

Eligibility
for people ages 18-40 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by John C Newman, MD, PhD (ucsf)
Headshot of John C Newman
John C Newman

Description

Summary

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 drink every day for six (6) 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

Keywords

Microbiome Analysis, Microbiome, Exogenous ketone, Ketone ester, Exogenous ketone ester

Eligibility

You can join if…

Open to people ages 18-40

  • 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
  • Subject is willing and able to comply with all study procedures including maintenance of habitual dietary intake, consumption of study product at specified intervals, virtual questionnaires including study log, habitual exercise and medication and supplement use, and the following prior and during test week: no alcohol, no cannabis products.
  • 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 and electronic questionnaires.
  • Subject has no health conditions that would prevent them from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history and routine laboratory test results.
  • Subject understands the study procedures and signs forms providing informed consent to participate in the study.

You CAN'T join if...

  • Subject is unable to converse in English
  • Subject is unable to provide informed consent due to cognitive impairment or insufficient English 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 Clinical Investigator), history of frequent diarrhea, history of surgery for weight loss, gastroparesis, systemic disease that might affect gut motility according to the Investigator, reflux requiring daily medication, history of gastrointestinal ulcers or bleeding, celiac disease, and/or clinically important lactose intolerance].
  • Subject is consistently using prescriptive or over-the counter medications where alcohol is a contraindication at the discretion of the Investigator.
  • 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 has a condition the Clinical Investigator 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.

Location

  • UCSF Wayne and Gladys Valley Center for Vision
    San Francisco California 94158 United States

Lead Scientist at University of California Health

  • John C Newman, MD, PhD (ucsf)
    Dr. Newman is a geriatrician, basic science researcher, and educator at the Buck Institute for Research on Aging and in the Division of Geriatrics at UCSF. As a physician-scientist, Dr. Newman hopes to translate what we are learning of the pathways that control fundamental mechanisms of aging into therapies that will improve the health and preserve the independence of older adults.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06954675
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated