Brain Vascular Function, Cognition
Conditions
Brief summary
Previously, beneficial effects of Aronia Melanocarpa extract (AME) supplementation on cognitive performance has been observed in healthy middle-aged adults. However, underlying mechanisms have not yet been addressed. In addition, effects of AME are unknown in subjects at increased risk of cognitive impairment. It is hypothesized that supplementation with AME enhances (regional) brain vascular function and brain insulin-sensitivity, thereby improving cognitive function of subjects at increased risk of cognitive impairment. The primary objectives are to investigate effects of AME intake on brain vascular function and insulin-sensitivity in cognitive-control brain areas, while we will also evaluate changes in cognitive function (secondary objective). The present study is a randomized, double-blind, placebo-controlled, cross-over trial consisting of two study groups and a pre- and post-test day in both study arms.
Interventions
DIETARY_SUPPLEMENTAronia
As described in experimental arm
DIETARY_SUPPLEMENTControl
As described in placebo comparator arm
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Men and women, aged between 55-75 years * BMI between 25-35 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
* Smoking or smoking cessation \< 12 months * Presence of diabetes mellitus * Active cardiovascular disease like congestive heart failure or cardiovascular event * Severe medical conditions, including asthma, chronic obstructive pulmonary disease (COPD), kidney failure, auto-inflammatory diseases or rheumatoid arthritis * Unstable body weight (weight gain or loss \> 3 kg in the past three months) * Use of dietary supplements or medication affecting the main outcomes of the study * Use of an investigational product within another biomedical intervention trial within the previous month * Contra-indications for MRI imaging (e.g., pacemaker, surgical clips/material in body, metal splinter in eye, claustrophobia) * Left-handedness * Familial hypercholesterolemia * Abuse of drugs * More than 3 alcoholic consumptions per day * Use medication to treat blood pressure, lipid or glucose metabolism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain Vascular function | Change after 6 weeks of intervention | cerebral blood flow as quantified non-invasively by the MRI perfusion method arterial spin labeling (ASL MRI). Higher cerebral blood flow indicates improved brain vascular function. |
| Brain insulin sensitivity | Change after 6 weeks of intervention | cerebral blood flow as quantified non-invasively by the MRI perfusion method arterial spin labeling (ASL MRI) before and after application of intranasal insulin (160 IU). Higher cerebral blood flow after intranasal insulin application indicates improved brain insulin sensitivity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive performance | Change after 6 weeks of intervention | Quantified through the Cambridge Neuropsychological Test Automated Battery (CANTAB). |
Countries
Netherlands
Outcome results
None listed