Aronia and Cognitive Fitness

NCT05268133 | Completed DMC

• 1 other identifier: METC 21-084
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Vascular Function; Cognition

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Cognitive performance

  Change after 6 weeks of intervention

Study Arms (2)

Aronia

EXPERIMENTAL

An aronia melanocarpa extract. Study volunteers will receive a daily oral dose of 160 mg AME for 6 weeks.

Dietary Supplement: Aronia

Control

PLACEBO COMPARATOR

Cellulose. Study volunteers will receive a daily oral dose of 160 mg cellulose for 6 weeks.

Dietary Supplement: Control

Interventions

Aronia DIETARY_SUPPLEMENT

As described in experimental arm

Aronia

Control DIETARY_SUPPLEMENT

As described in placebo comparator arm

Control

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Metabolic Research Unit Maastricht

Maastricht, Netherlands

Location

Related Publications (1)

• Ahles S, Plat J, Nijssen KM, Joris PJ. Aronia melanocarpa extract supplementation affects brain vascular function and cognitive performance: A randomized, double-blind, placebo-controlled, cross-over study in older adults with overweight or obesity. Clin Nutr. 2025 Dec 29;57:106561. doi: 10.1016/j.clnu.2025.106561. Online ahead of print.

  PMID: 41499921 DERIVED

Study Officials

• Peter J Joris, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 7, 2022
• Study Start: June 8, 2022
• Primary Completion: August 25, 2023
• Study Completion: August 25, 2023
• Last Updated: September 24, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)