Aronia and Cognitive Fitness

Study Overview
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Brief Summary
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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.

Official Title
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Aronia and Cognitive Fitness: Focus on Brain Insulin-Sensitivity and Vascular Function

Conditions
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Brain Vascular Function, Cognition

Intervention / Treatment
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* Dietary Supplement: Aronia
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aronia<br>An aronia melanocarpa extract. Study volunteers will receive a daily oral dose of 160 mg AME for 6 weeks. | Dietary Supplement: Aronia<br>* As described in experimental arm<br>|
| Placebo Comparator: Control<br>Cellulose. Study volunteers will receive a daily oral dose of 160 mg cellulose for 6 weeks. | Dietary Supplement: Control<br>* As described in placebo comparator arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain Vascular function | 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. | Change after 6 weeks of intervention | 
| Brain insulin sensitivity | 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 | Change after 6 weeks of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive performance | Quantified through the Cambridge Neuropsychological Test Automated Battery (CANTAB). | Change after 6 weeks of intervention |