Do Ketone Drinks Improve Immune, Metabolic and Cognitive Health in Older Adults

NCT06068803 | Unknown

• 1 other identifier: 23/SW/0067
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Aging

Keywords

Ketone

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day during baseline period and 1 day during the intervention period

Secondary Outcomes (24)

• Change in glycemic variability

  1 day during baseline period and 1 day during the intervention period

• Change in serum fructosamine

  Pre (day 0) and post (day 29)

• Change in fasting plasma glucose

  Pre (day 0) and post (day 29)

• Change in fasting lipid profile concentrations

  Pre (day 0) and post (day 29)

• Change in fasting plasma free fatty acids (FFA)

  Pre (day 0) and post (day 29)

Other Outcomes (7)

• Change in physical activity level (PAL)

  Pre (day 0) and post (day 29)

• Change in heart rate

  Pre (day 0) and post (day 29)

• Change in score on Pittsburgh Sleep Quality Index

  Pre (day 0) and post (day 29)

Study Arms (2)

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.

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.

Dietary Supplement: Placebo

Interventions

Ketone drink DIETARY_SUPPLEMENT

Participants will consume three daily ketone monoester (KME) drinks (0.282g KME/kg body weight/ serving) for 4 weeks.

Also known as: D-β-hydroxybutyrate-R 1,3-Butanediol

Ketone drink

Placebo DIETARY_SUPPLEMENT

Participants will consume three daily taste-matched calorie-free placebo drinks for 4 weeks.

Placebo

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Living in a residential care home
• 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

Sponsors & Collaborators

• University of Bath: lead

Study Sites (1)

University of Bath

Bath, Somerset, BA2 7AY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Ketosis

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Anna Nicholas

CONTACT

+44 7724 303532; an915@bath.ac.uk

Dylan Thompson

CONTACT

+44 1225 383177; spsdt@bath.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: October 5, 2023
• Study Start: September 14, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: October 5, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)