Your session is about to expire
← Back to Search
Ketone Body Supplement
Ketone Supplements for Muscle Health in Older Adults (KBR Trial)
N/A
Waitlist Available
Led By Tyler A Churchward-Venne, PhD
Research Sponsored by McGill University
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 day 0-5 and day 5-10
Awards & highlights
KBR Trial Summary
This trial will investigate if ketone supplements can improve muscle health in older adults during bed rest.
Who is the study for?
Healthy older adults aged 65-85 who haven't done resistance training for the past 6 months can join. They must be willing to follow study rules and not engage in any structured exercise during the trial. Excluded are those with a BMI outside of 18.5-30, pre-menopausal women, tobacco users, certain medication users, and individuals with specific medical conditions.Check my eligibility
What is being tested?
The study tests if ketone supplements can prevent muscle and mitochondrial function decline compared to a control drink in older adults during bed rest. Participants will receive either ketones or an energy-matched placebo beverage over five days of bed rest.See study design
What are the potential side effects?
Potential side effects from the ketone supplement may include gastrointestinal discomfort such as nausea or stomach pain, changes in blood sugar levels, bad taste in mouth, dizziness or headache.
KBR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0-5 and day 5-10
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0-5 and day 5-10
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in integrated fractional synthesis rate (%/d) in response to bed rest with and without ketone monoester (KET) supplementation.
Secondary outcome measures
2H enrichments in body water before and during bed rest with and without ketone monoester (KET) supplementation.
2H-alanine enrichment in venous blood before and during bed rest with and without ketone monoester (KET) supplementation.
Average habitual dietary intake assessed using Keenoa for 3 days (a food tracker application).
+30 moreKBR Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Exogenous ketone monoester (KET)Experimental Treatment1 Intervention
KET will be provided at a dose of 360 mg kg-1 body mass per serving at 2 servings per day between each main meal (ΔG®; TΔS Ltd, UK, Oxford, UK).
Group II: Energy matched control (CON)Active Control1 Intervention
CON will be provided at a dose energy matched to the KET supplement and consist of both carbohydrate (i.e., fructose) and fat (i.e., corn and canola oil 50:50 ratio). 1/3 of the supplemental energy will come from carbohydrate while 2/3 will come from fat. We have excluded protein from the CON supplement since it is well established to influence our primary outcome measure (MPS rates). A non-caloric sweetener will also be added to the CON supplement.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ketone monoester (R)-3-hydroxybutyl (R)-3- hydroxybutyrate
2023
N/A
~30
Find a Location
Who is running the clinical trial?
McGill UniversityLead Sponsor
394 Previous Clinical Trials
998,351 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,340 Previous Clinical Trials
26,452,668 Total Patients Enrolled
Tyler A Churchward-Venne, PhDPrincipal InvestigatorMcGill University
1 Previous Clinical Trials
24 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been in a study using a special kind of atom called "stable isotope" in the past year.Your body mass index (BMI) is either too low or too high.Older men and women who are in good health.You use tobacco and vaping products regularly.You are taking certain medications that affect how your muscles work, like corticosteroids or non-steroidal anti-inflammatory drugs.You are not taking any over-the-counter protein supplements, creatine, or fish oil.You have used illegal drugs like growth hormone or testosterone.You have a history of blood clots, type 2 diabetes, memory loss, heart problems, bone or joint issues, or severe allergies.
Research Study Groups:
This trial has the following groups:- Group 1: Energy matched control (CON)
- Group 2: Exogenous ketone monoester (KET)
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.
Does eligibility for this clinical experiment include individuals over 45 years of age?
"The necessary requirements for enrolment in this medical study is a patient age between 65 and 80. There are 333 trials open to seniors and 162 reserved for minors."
Answered by AI
Is the study now accepting new participants?
"Per the information on clinicaltrials.gov, this study is presently looking for participants to take part in it - with its inaugural posting occurring on January 1st 2023 and a subsequent update taking place on 21/1/2023."
Answered by AI
What is the aggregate amount of participants undergoing this experiment?
"Affirmative. The clinicaltrial.gov website attests to the current recruitment of participants for this medical trial, which was initially posted on January 1st 2023 and last updated on the 21st of January 2021. A total of 36 people are needed from a single testing site."
Answered by AI
Is there a way I can join this research project?
"This study seeks 36 geriatric patients with muscle wasting, who are male or female and deemed healthy as determined by a 2020 PAR-Q+, medical screening questionnaire, GAQ, and COVID-19 symptom questionnaire. Moreover, participants must not have engaged in structured resistance training for a period of 6 months before enrolment. It is essential that all subjects abide by the compliance rules stipulated in this trial."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger