AgingNCT06068803
Do Ketone Drinks Improve Immune, Metabolic and Cognitive Health in Older Adults
A study testing Ketone drink in people with Aging, run by University of Bath at 1 site in United Kingdom.
Trial 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 80 with stable health. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Ketone drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Sep 2023to 18 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Immunometabolic and Cognitive Effects of 4 Weeks of Ketone Supplementation in Older Adults
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 80 with stable health. The main objectives are to assess the effects of the intervention versus placebo on markers of metabolic health, inflammation, immune function, adipose tissue, and cognitive performance.
Participants will undergo two weeks of baseline monitoring followed by a four-week supplementation period in which they will drink a ketone monoester drink or taste-matched placebo three times a day. During these periods, participants will record their diet and supplement intake and their physical activity and blood glucose will be monitored using wearable devices. At the beginning and end of the supplementation period, participants will undergo testing in the university physiology laboratories, involving blood, expired air and adipose tissue samples, as well as cognitive tests, physical tests and questionnaires.
Read the 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. Ketones are natural molecules that are produced by the body when people fast (abstain from eating) for longer than 16-24 hours or eat a diet low in carbohydrates. It is now possible to consume ketones in the form of a drink.
Aims: This study aims to investigate if consuming a ketone drink for four weeks improves immunometabolic and cognitive health in adults aged 60 to 80 years. The main objectives are to assess the effects of the intervention versus placebo on:
- Markers of metabolic health, including glucose control, lipid profile, blood pressure and body composition;
- Systemic inflammation, immune cell activation and pro-inflammatory cytokine production;
- Gene expression and secretory profile of subcutaneous adipose tissue; and
- Cognitive performance and physical function.
Methods: The study is a randomised, double-blinded, placebo-controlled trial. Thirty participants (male and female) aged 60 to 80 years old with stable health will be recruited. Participants will undergo two weeks of baseline monitoring followed by a four-week supplementation period in which they will drink a ketone monoester drink or placebo three times a day. During these periods, participants will record their diet and supplement intake and their physical activity and blood glucose will be monitored using wearable devices. For two days in the supplementation period, participants will replicate their food consumption and physical activity so that they match two days in the baseline period (these are known as matched meal and activity days).
At the beginning and end of the supplementation period, participants will come to the physiology laboratories at the University of Bath for testing. Here, measures will be taken of their body weight, body composition, blood pressure, cognitive function and physical function, as well as samples of expired air, fat tissue and blood for analysis. Sleep and quality of life will be assessed via questionnaires.
- Conditions
- Aging
- Being tested
- Ketone drink, Placebo
- Keywords
- Ketone
- Medical subject headings
- Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone drinkDietary supplement
Also called D-β-hydroxybutyrate-R 1,3-Butanediol
Participants will consume three daily ketone monoester (KME) drinks (0.282g KME/kg body weight/ serving) for 4 weeks.
PlaceboDietary supplement
Participants will consume three daily taste-matched calorie-free placebo drinks for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ketone drink | Experimental | Pre-intervention (baseline) and post-intervention measurements will be obtained before and after the 4-week supplementation period. Physical activity and blood glucose will be monitored using wearable devices. Receives: Dietary Supplement: Ketone drink |
| Placebo | Placebo comparator | Pre-intervention (baseline) and post-intervention measurements will be obtained before and after the 4-week supplementation period. Physical activity and blood glucose will be monitored using wearable devices. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24hr average glucose area under the curve (AUC)
Glucose control will be measured using a continuous glucose monitoring device worn throughout the baseline period and weeks 3 and 4 of the intervention period. Change in 24h average glucose AUC will be assessed on 'matched meal and activity days' i.e. days during intervention and baseline that are matched for food intake and physical activity.
Measured: 1 day during baseline period and 1 day during the intervention period
Secondary outcomes (24)
Change in glycemic variability
Glucose control will be measured using continuous glucose monitoring device worn throughout the baseline period and weeks 3 and 4 of the intervention period. Change in glycemic variability will be assessed on 'matched meal and activity days' i.e. days during intervention and baseline that are matched for food intake and physical activity.
Measured: 1 day during baseline period and 1 day during the intervention period
Change in serum fructosamine
Measured in fasting blood sample by automated analyser (Daytona Rx)
Measured: Pre (day 0) and post (day 29)
Change in fasting plasma glucose
Measured in fasting blood sample by automated analyser (Daytona Rx)
Measured: Pre (day 0) and post (day 29)
Change in fasting lipid profile concentrations
Measured in fasting blood sample by automated analyser (Daytona Rx)
Measured: Pre (day 0) and post (day 29)
Change in fasting plasma free fatty acids (FFA)
Measured in fasting blood sample by automated analyser (Daytona Rx)
Measured: Pre (day 0) and post (day 29)
Change in fasting plasma insulin
Measured in fasting blood sample using a high-sensitivity human insulin enzyme-like immunosorbent assay (ELISA)
Measured: Pre (day 0) and post (day 29)
Change in Insulin Sensitivity Index
Calculated from fasting plasma insulin and fasting plasma glucose
Measured: Pre (day 0) and post (day 29)
Change in Adipose tissue Insulin Resistance index (Adipo-IR)
Calculated from fasting plasma insulin and fasting plasma FFA
Measured: Pre (day 0) and post (day 29)
Change in body mass
Measured using a digital body weight scales
Measured: Pre (day 0) and post (day 29)
Change in waist and hip circumference
Measured using a measurement tape
Measured: Pre (day 0) and post (day 29)
Change in waist to hip ratio
Calculated from waist and hip circumferences
Measured: Pre (day 0) and post (day 29)
Change in fat mass and fat free mass
Assessed by Dual Energy X-ray Absorptiometry (DEXA) scan
Measured: Pre (day 0) and post (day 29)
Change in calf muscle density, quality and area
Assessed by calf peripheral Quantitative Computed Tomography (pQCT)
Measured: Pre (day 0) and post (day 29)
Change in blood pressure
Measured using an automated blood pressure device. Both systolic and diastolic blood pressure will be measured
Measured: Pre (day 0) and post (day 29)
Change in circulating adipokines and inflammatory cytokines
Key inflammatory cytokines including CRP will be quantified by R-plex, U-plex and V-plex kits on a Mesoscale QuickPlex SQ120
Measured: Pre (day 0) and post (day 29)
Change in blood immune cell phenotype, function and activation
Peripheral blood mononuclear cells (PBMCs) isolated from whole blood will be incubated with fluorophore-conjugated antibodies and analysed with a flow cytometer to examine the phenotype and cytokine production of immune cells
Measured: Pre (day 0) and post (day 29)
Change in adipose tissue immune cell phenotype, function and activation
Adipose tissue stromal vascular fraction (SVF) will be incubated with fluorophore-conjugated antibodies and analysed with a flow cytometer to examine the phenotype and cytokine production of immune cells
Measured: Pre (day 0) and post (day 29)
Change adipose tissue adipokine and cytokine concentrations
Adipose tissue explants will be cultured ex vivo for 3h. Concentrations of key adipokines and cytokines in supernatant will be quantified by R-plex, U-plex and V-plex kits on a Mesoscale QuickPlex SQ120
Measured: Pre (day 0) and post (day 29)
Change in adipose tissue gene expression
Whole-tissue RNAseq
Measured: Pre (day 0) and post (day 29)
Change in Digit-Symbol Substitution Test score
This test will be administered using the computer-based app Inquisit6 Lab (Millisecond). The score reflects the number of correct symbols within the allowed time. Higher is better.
Measured: Pre (day 0) and post (day 29)
Change in Stroop Test score
This test will be administered using the computer-based app Inquisit6 Lab (Millisecond). The score reflects the number of correct responses and the response latency. Higher is better.
Measured: Pre (day 0) and post (day 29)
Change in Trail Making Task score
This test will be administered using the computer-based app Inquisit6 Lab (Millisecond). The score reflects the time taken to complete trails A and B. Lower is better.
Measured: Pre (day 0) and post (day 29)
Change in Digit Span Test score
This test will be administered using the computer-based app Inquisit6 Lab (Millisecond). The score reflects the maximum number of digits recalled correctly. Higher is better.
Measured: Pre (day 0) and post (day 29)
Change in score on Montreal Cognitive Assessment (MoCA)
The test will be administered by a trained researcher.
Measured: Pre (day 0) and post (day 29)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start14 Sep 2023
- Primary completion18 Dec 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Nicholas, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068803
- Sponsor's protocol ID
- 23/SW/0067
- Status last verified
- Jul 2026
- First submitted
- 13 Sep 2023
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Immunometabolic and Cognitive Effects of 4 Weeks of Ketone Supplementation in Older Adults
- ClinicalTrials.gov ID
- NCT06068803
- Acronym / sponsor ID
- 23/SW/0067
- Conditions
- Aging
- Keywords
- Ketone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 80 with stable health. The main objectives are to assess the effects of the intervention versus placebo on markers of metabolic health, inflammation, immune function, adipose tissue, and cognitive performance.
Participants will undergo two weeks of baseline monitoring followed by a four-week supplementation period in which they will drink a ketone monoester drink or taste-matched placebo three times a day. During these periods, participants will record their diet and supplement intake and their physical activity and blood glucose will be monitored using wearable devices. At the beginning and end of the supplementation period, participants will undergo testing in the university physiology laboratories, involving blood, expired air and adipose tissue samples, as well as cognitive tests, physical tests and questionnaires.
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. Ketones are natural molecules that are produced by the body when people fast (abstain from eating) for longer than 16-24 hours or eat a diet low in carbohydrates. It is now possible to consume ketones in the form of a drink.
Aims: This study aims to investigate if consuming a ketone drink for four weeks improves immunometabolic and cognitive health in adults aged 60 to 80 years. The main objectives are to assess the effects of the intervention versus placebo on:
- Markers of metabolic health, including glucose control, lipid profile, blood pressure and body composition;
- Systemic inflammation, immune cell activation and pro-inflammatory cytokine production;
- Gene expression and secretory profile of subcutaneous adipose tissue; and
- Cognitive performance and physical function.
Methods: The study is a randomised, double-blinded, placebo-controlled trial. Thirty participants (male and female) aged 60 to 80 years old with stable health will be recruited. Participants will undergo two weeks of baseline monitoring followed by a four-week supplementation period in which they will drink a ketone monoester drink or placebo three times a day. During these periods, participants will record their diet and supplement intake and their physical activity and blood glucose will be monitored using wearable devices. For two days in the supplementation period, participants will replicate their food consumption and physical activity so that they match two days in the baseline period (these are known as matched meal and activity days).
At the beginning and end of the supplementation period, participants will come to the physiology laboratories at the University of Bath for testing. Here, measures will be taken of their body weight, body composition, blood pressure, cognitive function and physical function, as well as samples of expired air, fat tissue and blood for analysis. Sleep and quality of life will be assessed via questionnaires.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketone drink | Experimental | Dietary Supplement: Ketone drinkPre-intervention (baseline) and post-intervention measurements will be obtained before and after the 4-week supplementation period. Physical activity and blood glucose will be monitored using wearable devices. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPre-intervention (baseline) and post-intervention measurements will be obtained before and after the 4-week supplementation period. Physical activity and blood glucose will be monitored using wearable devices. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketone drinkAlso: D-β-hydroxybutyrate-R 1,3-ButanediolParticipants will consume three daily ketone monoester (KME) drinks (0.282g KME/kg body weight/ serving) for 4 weeks. | Dietary supplement | Ketone drink |
| PlaceboParticipants will consume three daily taste-matched calorie-free placebo drinks for 4 weeks. | Dietary supplement | Placebo |
Primary outcome
Change in 24hr average glucose area under the curve (AUC)
Time frame: 1 day during baseline period and 1 day during the intervention period
Glucose control will be measured using a continuous glucose monitoring device worn throughout the baseline period and weeks 3 and 4 of the intervention period. Change in 24h average glucose AUC will be assessed on 'matched meal and activity days' i.e. days during intervention and baseline that are matched for food intake and physical activity.
24 secondary outcomes
Change in glycemic variability
Time frame: 1 day during baseline period and 1 day during the intervention period
Change in serum fructosamine
Time frame: Pre (day 0) and post (day 29)
Change in fasting plasma glucose
Time frame: Pre (day 0) and post (day 29)
Change in fasting lipid profile concentrations
Time frame: Pre (day 0) and post (day 29)
Change in fasting plasma free fatty acids (FFA)
Time frame: Pre (day 0) and post (day 29)
Change in fasting plasma insulin
Time frame: Pre (day 0) and post (day 29)
Change in Insulin Sensitivity Index
Time frame: Pre (day 0) and post (day 29)
Change in Adipose tissue Insulin Resistance index (Adipo-IR)
Time frame: Pre (day 0) and post (day 29)
Change in body mass
Time frame: Pre (day 0) and post (day 29)
Change in waist and hip circumference
Time frame: Pre (day 0) and post (day 29)
Change in waist to hip ratio
Time frame: Pre (day 0) and post (day 29)
Change in fat mass and fat free mass
Time frame: Pre (day 0) and post (day 29)
Change in calf muscle density, quality and area
Time frame: Pre (day 0) and post (day 29)
Change in blood pressure
Time frame: Pre (day 0) and post (day 29)
Change in circulating adipokines and inflammatory cytokines
Time frame: Pre (day 0) and post (day 29)
Change in blood immune cell phenotype, function and activation
Time frame: Pre (day 0) and post (day 29)
Change in adipose tissue immune cell phenotype, function and activation
Time frame: Pre (day 0) and post (day 29)
Change adipose tissue adipokine and cytokine concentrations
Time frame: Pre (day 0) and post (day 29)
Change in adipose tissue gene expression
Time frame: Pre (day 0) and post (day 29)
Change in Digit-Symbol Substitution Test score
Time frame: Pre (day 0) and post (day 29)
Change in Stroop Test score
Time frame: Pre (day 0) and post (day 29)
Change in Trail Making Task score
Time frame: Pre (day 0) and post (day 29)
Change in Digit Span Test score
Time frame: Pre (day 0) and post (day 29)
Change in score on Montreal Cognitive Assessment (MoCA)
Time frame: Pre (day 0) and post (day 29)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketone drink in people with Aging, run by University of Bath at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24hr average glucose area under the curve (AUC) (time frame: 1 day during baseline period and 1 day during the intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.