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NCT06395051 | Not yet recruiting | Brain Insulin Sensitivity

Effects of Ketone Monoesters on Brain Function
Sponsor:

Maastricht University Medical Center

Brief Summary:

Disturbances in brain insulin-sensitivity are not only observed in obesity and type 2 diabetes (T2D), but also during brain aging and in dementia. Ketone monoester supplements may improve brain insulin-sensitivity, which can be quantified by measuring the gray-matter cerebral blood flow (CBF) response to intranasally administered insulin. We hypothesize that acute ketone monoester supplementation increases (regional) brain vascular function and insulin-sensitivity thereby improving cognitive performance and appetite control. The primary objective is to evaluate in older men the acute effect of ketone monoester supplementation on (regional) brain vascular function and insulin-sensitivity, as quantified by the non-invasive gold standard magnetic resonance imaging (MRI)-perfusion method Arterial Spin Labelling (ASL). The CBF response to intranasal insulin is a robust and sensitive physiological marker of brain insulin-sensitivity. Secondary objectives are to investigate effects on cognitive performance as assessed with a neuropsychological test battery, and appetite control as quantified by functional MRI (fMRI) with visual food cues.

Condition or disease

Brain Insulin Sensitivity

Brain Vascular Function

Cerebral Blood Flow

Cognitive Performance

Appetite Control

Intervention/treatment

Ketone Monoester

Placebo

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 18 participants
Masking : Triple
Primary Purpose : Prevention
Official Title : Acute Effects of Ketone Monoester Supplementation on Brain Function in Older Men With Overweight
Actual Study Start Date : July 1, 2024
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025
Arm Intervention/treatment

Experimental: Experimental

Ketone monoesters

Dietary Supplement: Ketone Monoester

Placebo Comparator: Placebo

Taste- and volume-matched placebo

Dietary Supplement: Placebo
Ages Eligible for Study: 60 Years to 75 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • Men, aged between 60-75 years
  • BMI between 25-30 kg/m2
  • Fasting plasma glucose < 7.0 mmol/L
  • Fasting serum TC < 8.0 mmol/L
  • Fasting serum TAG < 4.5 mmol/L
  • Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg
  • Stable body weight (weight gain or loss < 3 kg in the past three months)
  • Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
  • No difficult venipuncture as evidenced during the screening visit
Exclusion Criteria
  • Women
  • Left-handedness
  • Following a low-carbohydrate diet or consuming nutritional ketone supplements
  • Current smoker, or smoking cessation < 12 months
  • Diabetic patients
  • Familial hypercholesterolemia
  • Abuse of drugs
  • More than 3 alcoholic consumptions per day
  • Use of products or dietary supplements known to interfere with the main outcomes as judged by the principal investigators
  • Use medication to treat blood pressure, lipid or glucose metabolism, or neurological or mental disorders.
  • Use of an investigational product within another biomedical intervention trial within the previous 1-month
  • Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
  • Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
  • Contra-indications for MRI imaging (e.g. pacemaker, surgical clips/material in body, metal splinter in eye, claustrophobia).
Effects of Ketone Monoesters on Brain Function

Location Details

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Effects of Ketone Monoesters on Brain Function

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Locations

Not yet recruiting

Netherlands, Limburg

Maastricht University Medical Center

Maastricht, Limburg, Netherlands,