Ketone drinks may enhance health in older adults
Investigating the Immunometabolic and Cognitive Effects of 4 Weeks of Ketone Supplementation in Older Adults
NA · University of Bath · NCT06068803
This study is testing if drinking ketone supplements every day can improve health, including brain and immune function, in older adults aged 60 to 80 years.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 60 Years to 80 Years |
| Sex | All |
| Sponsor | University of Bath (other) |
| Locations | 1 site (Bath, Somerset) |
| Trial ID | NCT06068803 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blinded, placebo-controlled trial investigates the effects of daily ketone supplementation on immune, metabolic, and cognitive health in adults aged 60 to 80 years. Participants will undergo two weeks of baseline monitoring followed by a four-week period where they will consume either a ketone drink or a placebo three times daily. The study will assess various health markers, including metabolic health, inflammation, immune function, and cognitive performance, using blood samples, adipose tissue biopsies, and cognitive tests. The aim is to determine if ketone drinks can provide significant health benefits in older adults.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 60 to 80 years who can comply with study procedures.
Not a fit: Patients with unstable or clinically active chronic diseases or those living in residential care homes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved immune, metabolic, and cognitive health in older adults.
How similar studies have performed: While research on ketones has shown promising effects in animal studies, this specific approach in older adults is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 60 to 80 years * Postmenopausal women must be \>1 year since last menses * Able to provide informed consent * Willing and able to comply with all study procedures including randomisation into any of the experimental groups; maintenance of habitual dietary intake, exercise, medication and supplement use over the 28-day intervention period; blood draws and adipose tissue biopsies; and abstinence from alcohol (\>24 h), food (\>10 h) and strenuous exercise (\>3 d) prior to trial days. Exclusion Criteria: * Living in a residential care home * Unstable or clinically active pulmonary, cardiac, hepatic, renal, endocrine, hematologic, immunologic, neurologic, psychiatric or biliary disorders. 'Unstable' refers to complications of a condition that are not controlled by medication or lifestyle and which require frequent monitoring and testing by a health professional. Stable chronic disease is not an exclusion criterion unless specified. * Diagnosed Type 1 or Type 2 Diabetes Mellitus * Diagnosed gastrointestinal condition which would potentially impact ability to consume study drink (e.g. inflammatory bowel disease, history of gastrointestinal ulcers or bleeding) * Diagnosed autoimmune condition * Previous major cardiovascular event (e.g. heart attack, stroke) * Past or current cancer diagnosis and treatment excluding non-melanoma skin cancers * Severe hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥120 mmHg), as defined by blood pressure measured at Visit 1 * Current tobacco or recreational drug use * Reported changes to use of thyroid, antihypertensive, antidepressant or statin medications within 30 days of Visit 1 * Taking medications that will interfere with the study outcomes * Known negative reaction to lidocaine anaesthetic and/or taking warfarin * Currently following a ketogenic diet or taking ketone supplements * Not weight stable in the prior 3 months (\>5% weight change) * Unable to converse in English
Where this trial is running
Bath, Somerset
- University of Bath — Bath, Somerset, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Anna Nicholas
- Email: an915@bath.ac.uk
- Phone: +44 7724 303532
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.