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Completed

NCT Number: NCT05268133

Aronia and Cognitive Fitness

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.

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Key information

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Metabolic Research Unit Maastricht

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aronia

Dietary Supplement

As described in experimental arm

Control

Dietary Supplement

As described in placebo comparator arm

Primary outcomes

  1. Brain Vascular function

    Time frame: 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.

  2. Brain insulin sensitivity

    Time frame: 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 outcomes

  1. Cognitive performance

    Time frame: Change after 6 weeks of intervention

    Quantified through the Cambridge Neuropsychological Test Automated Battery (CANTAB).

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 7, 2022
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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