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Search / Trial NCT06588946

Β-OHB Supplementation and Brain Health in Older Adults

Launched by MCMASTER UNIVERSITY · Sep 5, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Early Stage Dementia Ketone Monoester Supplementation Cerebral Blood Flow Cognition Resting State Functional Magnetic Resonance Imaging Placebo

ClinConnect Summary

This clinical trial is investigating whether a special supplement called ketone monoester (KME) can help improve brain function in older adults who feel they are experiencing memory problems, known as subjective cognitive decline. Researchers want to see if taking KME will increase blood flow in the brain and enhance how different areas of the brain communicate with each other. Participants will be randomly assigned to take either the KME supplement or a placebo (a non-active pill) for two weeks. After a break, they will switch to the other treatment for another two weeks, allowing researchers to compare the effects.

To participate in this trial, you should be generally healthy and have a good score on a memory test (Montreal Cognitive Assessment) indicating you're cognitively normal. You should also be living independently and able to move around on your own. However, if you have certain health conditions, like mild cognitive impairment, heart disease, or if you smoke, you may not be eligible. During the trial, participants will undergo assessments before and after each treatment period to track any changes. This study is not yet recruiting, but it aims to gather important information about brain health in older adults.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Being objectively cognitively normal as determined by a Montreal Cognitive Assessment (MoCA) score ≥26 with independent living and ambulating
  • SCD will be determined using the Prospective-Retrospective Memory Questionnaire (PRMQ) following the SCD Initiative Working Group framework
  • Exclusion Criteria:
  • A diagnosis of mild cognitive impairment, dementia, or psychiatric and/or mood disorders (e.g., major depression)
  • MoCA score \<26
  • Diagnosis of cardiometabolic disease (e.g., hypertension, type 2 diabetes)
  • Obesity (BMI \>30 kg/m2)
  • History of heart attack or stroke
  • History of smoking
  • Currently following a ketogenic diet or taking ketogenic supplements
  • Having MRI contraindications
  • Participants with literacy, visual, hearing, and/or speech issues, as well as individuals who are not proficient in English will not be eligible for this trial

About Mcmaster University

McMaster University, a leading research institution located in Hamilton, Ontario, Canada, is renowned for its innovative approach to education and its commitment to advancing healthcare through rigorous clinical research. The university's diverse research programs are supported by a multidisciplinary team of experts dedicated to improving patient outcomes and public health. With a strong emphasis on evidence-based medicine, McMaster University actively engages in clinical trials that explore new therapies, interventions, and health technologies, fostering collaboration among researchers, healthcare professionals, and industry partners to translate findings into real-world applications.

Locations

Hamilton, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

Jeremy Walsh, PhD

Principal Investigator

McMaster University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported