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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25g Bis-octanoyl-(R)-1,3-butanediol (C8) | Experimental | Participants will receive 25g of the ketone ester bis-octanoyl-(R)-1,3-butanediol (C8) daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exogenous ketone ester | Dietary Supplement | 25g Bis-octanoyl-(R)-1,3-butanediol (C8) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline sampling to final sampling, including intervention period, at 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sidharth S Madhavan, PhD | Contact | 248-797-1025 | sidharth.madhavan@ucsf.edu | |
| John C Newman, MD, PhD | Contact | 415-502-5134 | Newman@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| John C Newman, MD, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Wayne and Gladys Valley Center for Vision | Recruiting | San Francisco | California | 94158 | United States |
This is a pilot study that will only be used to inform future trial design, no IPD will be shared externally.
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| From start to end of intervention at 7 days |