BIKE STUDY
RECRUITMENT CLOSED
We successfully completed our very first clinical trial at the Buck, the Buck Institute Ketone Ester (BIKE) Study, in January 2024. The BIKE Study was the first study to test the safety and tolerance of ketone drinks in older adults and gave us exploratory data to understand how ketones might affect healthy aging.
We are still underway with the process of data analysis. This will result in multiple papers from this study! We have published two papers in peer-reviewed journals and have two papers available as preprints. A preprint means this paper has not passed the process of peer review yet, but we have submitted the papers to journals for review! The publications for this study are available at the following links.
Study Methods Paper | This paper explains the rationale and methods used to conduct the BIKE Study. This paper does not include any data from the study but provides detailed information about the tests and evaluations done during the study and why these tests were chosen!
Short Term Ketone Responses Paper | This paper presents data collected from study visits exploring what the body does to the ketone drink over a short time frame and how the drink interacts with the body over a few hours. The main goal of this portion of the study was to examine the beverage's ketogenic effect on blood BHB and blood glucose concentrations and determine tolerance over a short period of time. We utilized two serving sizes of two formulations of the ketone ester molecule. We are happy to report that the study products were well tolerated and increased blood BHB concentrations to exceed the threshold for nutritional ketosis. This response was greater for the greater serving size, consistent with ‘dose responsiveness.
Long Term Safety and Tolerance Paper | This paper presents data collected from the 12-week BIKE study, examining the safety and tolerability of the ketone ester beverage. Tolerability was assessed using a daily log and bi-weekly phone interviews. Safety was assessed by vital signs, blood work lab values, and a tabulation of adverse events. We are happy to conclude that the beverage was safe and well-tolerated in healthy older adults in this 12-week study.
Physical and Cognitive Function and Quality of Life Paper | This paper presents data collected from the 12-week BIKE study, examining changes in physical function, cognitive performance, and quality of life. There were no statistically significant changes in these measures, however this is not surprising for the small size of this pilot study. We are excited to follow up on these measurements in the TAKEOFF Study.
Upcoming analysis and publications include examining biomarkers, immune makeup and function, and microbiome characterization.
Clinical Trials Details
Participants: Healthy people at, or over the age of 65
Location: The Buck Institute, Novato, CA
Dates: Study started December 2022, estimated completion December 2023
Duration: Participation in the study will last approximately 4 months
Compensation: Compensation of up to $500 is offered for the completion of this study
Status: No longer recruiting
Start date: December 2022
End date: December 2023 (estimated)
Sponsor: The Buck Institute for Research on Aging, through a gift by Dr James B Johnson, MD.
Links: https://clinicaltrials.gov/study/NCT05585762
ID: NCT05585762
Study type: Randomized, parallel group, double blinded
Participants: 30 participants
Last updated: Dec 2, 2024
Number of visits:
- One screening visit in clinic
- 4 study visits in clinic
List of study procedures:
- Medical history
- Height, weight, waist circumference
- Vital signs (pulse and blood pressure, etc)
- Fasting blood work
- Urine sampling in clinic
- Daily consumption of study drink at home for 12 weeks
- Study questionnaires
- Physical activity monitoring (FitBit)
- Physical tests (balance, walking, strength, etc)
- Mental tests (memory, cognition, etc).
- Ketone and glucose monitoring (in clinic and at home).
- Stool sample collection
You can join if you…
- are 65 years of age or older
- have a BMI between 18.5 – 34.9 k/m2
- are living independently
- have no medical conditions that have changed recently or medication use that has changed recently
- have a Bluetooth enabled smart phone and access to the internet
You can’t join if…
- you live in a setting where you receive assistance with your activities of daily living
- your medical history, medication/supplement list or screening blood tests show a condition or recent changes that means that the medical officer decides it is not safe for you to participate
- you have a cognitive condition that means you cannot give informed consent to take part
- you have an allergy to milk or soy
- you follow a strict diet (such as ketogenic diet)
John Newman, MD, PhD
John Newman, MD, PhD, is an Assistant Professor at the Buck Institute for Research on Aging and an Associate Professor in the Division of Geriatrics at University of California San Francisco (UCSF). His career goal is to translate our expanding understanding of aging biology to improve the care and help maintain the independence of older adults. His research at the Buck Institute studies the molecular details of how diet and fasting regulate the genes and pathways that in turn control aging, focusing on the ketone body beta-hydroxybutyrate and how its molecular signaling activities involving epigenetics and inflammation regulate aging and memory in mice.
Dr. Newman is also a geriatrician who cares for hospitalized older adults at UCSF and the San Francisco VA Medical Center, focusing on preserving mobility and preventing delirium.
