Aronia and Cognitive Fitness

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cognition; Brain Vascular Function
• Intervention / Treatment: Dietary supplement: Aronia; Dietary supplement: Control

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Metabolic Research Unit Maastricht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Investigators: Principal Investigator: Peter J Joris, PhD, Maastricht University

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): March 7, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: METC 21-084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No