Status:
UNKNOWN
Do Ketone Drinks Improve Immune, Metabolic and Cognitive Health in Older Adults
Lead Sponsor:
University of Bath
Conditions:
Aging
Eligibility:
All Genders
60-80 years
Phase:
NA
Brief Summary
The goal of this randomised, double-blinded, placebo-controlled trial is to investigate the immune, metabolic and cognitive effects of four weeks of daily ketone supplementation in adults aged 60 to 8...
Detailed Description
Background: Research shows that ketones have beneficial effects on metabolism, inflammation and brain health in humans. In mice, they have also been shown to influence pathways involved in ageing. Ket...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06068803
Start Date
September 14 2023
End Date
September 30 2025
Last Update
October 5 2023
Active Locations (1)
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1
University of Bath
Bath, Somerset, United Kingdom, BA2 7AY