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
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 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.
Single group
Exogenous ketone ester
Dietary supplement25g Bis-octanoyl-(R)-1,3-butanediol (C8)
Longitudinal Change in Microbiome Composition
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.
Acute Tolerability Symptoms related to Product Ingestion
Symptoms will be assessed daily using a standardized Beverage Tolerability Questionnaire (Stubbs et al. J Nutr Health Aging 2024). Symptoms are rated on a scale of mild, moderate, and severe with the following symptoms: 1) gas/flatulence; 2) nausea; 3) vomiting; 4) abdominal cramping; 5) stomach rumbling; 6) burping; 7) reflux/heartburn; 8) diarrhea; 9) headache; and 10) dizziness.
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