Acute effects of ketone monoester supplementation on brain function in older men with overweight

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 36

Inclusion Criteria

- Men, aged between 60-75 years
- BMI between 25-30 kg/m2
- Fasting plasma glucose < 7.0 mmol/L
- Fasting serum total cholesterol < 8.0 mmol/L
- Fasting serum triacylglycerol < 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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the acute effect of ketone monoesters as compared with<br /><br>placebo on (regional) brain vascular function and insulin-sensitivity, as<br /><br>assessed by the gray-matter CBF response to intranasally administered insulin<br /><br>using MRI ASL. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are the acute effects of ketone monoesters as compared with<br /><br>placebo on cognitive performance, as assessed with a neuropsychological test<br /><br>battery (CANTAB), and appetite-related brain reward activity, as quantified by<br /><br>the blood oxygenation level-dependent (BOLD)-fMRI response to food cues.</p><br>