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Ketone Ester
Ketone Ester for Aging (BIKE Trial)
N/A
Waitlist Available
Led By John C Newman, MD, PhD
Research Sponsored by Buck Institute for Research on Aging
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from pre-test to week 1, week 4 and week 12.
Awards & highlights
BIKE Trial Summary
This trial is researching how a ketone ester ingredient affects healthy older adults (65+) over 12 weeks. Participants will rate side effects and safety will be assessed with blood & urine samples, vital signs, body weight, & monitoring of adverse events. Pilot data will explore the effects of the ingredient on physical & cognitive function and quality of life.
Who is the study for?
Healthy older adults over 65 with a BMI of 18.5-34.9 kg/m2 can join this trial if they have no major health issues, are not on certain medications, and haven't used ketone supplements recently. They must be able to follow the study's diet and exercise guidelines, provide informed consent, and not require assistance with daily living or live in an institution.Check my eligibility
What is being tested?
The trial is testing the safety and tolerability of a ketone ester (KE) compared to a non-ketone placebo over 12 weeks in healthy seniors. It involves daily consumption of KE, monitoring through questionnaires, blood/urine tests, vital signs checks, body weight tracking, and assessing any adverse events.See study design
What are the potential side effects?
Possible side effects from consuming the ketone ester may include digestive discomfort as reported by participants using Beverage Tolerability Questionnaires. Blood and urine tests will help monitor for other potential side effects related to organ function.
BIKE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from pre-test to week 1, week 4 and week 12.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from pre-test to week 1, week 4 and week 12.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Tolerance
Secondary outcome measures
Ketone changes 4h after ketone ester drinks
Safety Blood Profile
Other outcome measures
Change in 1 rep max leg press
Change in 6 minute walk test
Change in Digit Symbol Substitution Task scores
+13 moreBIKE Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ketone esterExperimental Treatment1 Intervention
Flavored ketone ester beverage 75 mL. Day 0 - 7: half of one bottle consumed daily. Day 8 to end (Week 12): one full bottle consumed daily.
Group II: Non-ketone placeboPlacebo Group1 Intervention
Flavored beverage with bitter additive 75 mL. Matched for appearance, taste and calories. Day 0 - 7: half of one bottle consumed daily. Day 8 to end (Week 12): one full bottle consumed daily.
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Who is running the clinical trial?
Biofortis Mérieux NutriSciencesOTHER
18 Previous Clinical Trials
2,551 Total Patients Enrolled
Buck Institute for Research on AgingLead Sponsor
2 Previous Clinical Trials
440 Total Patients Enrolled
John C Newman, MD, PhDPrincipal InvestigatorBuck Institute
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken antibiotics within the last 30 days before the study visits.You have taken ketone supplements (like ketone salts or esters, and medium chain triglycerides [MCT]) within the last 30 days before your first, second, or third visit.You have a history of drinking too much alcohol or using drugs.You follow extreme diets or have recently used weight-loss medications or programs.
Research Study Groups:
This trial has the following groups:- Group 1: Ketone ester
- Group 2: Non-ketone placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available for individuals to enroll in this clinical trial?
"Affirmative. Clinicaltrials.gov shows that this research endeavor, which was originally posted on November 28th 2022, is actively enrolling individuals for a clinical trial. It requires 30 subjects to be recruited from 1 site."
Answered by AI
What is the estimated headcount of participants in this research endeavor?
"Absolutely. As per the details available via clinicaltrials.gov, this research is still recruiting individuals and was first announced on November 28th 2022 with an edit made a week later. 30 people are required for participation at 1 healthcare site."
Answered by AI
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