Aronia and Cognitive Fitness

Cognition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05268133
• Other study ID #: METC 21-084
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 8, 2022
• Est. completion date: August 2023

Study information

• Verified date: March 2023
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Vascular Function
• Cognition

Intervention

Dietary Supplement:
• Aronia
As described in experimental arm
• Control
As described in placebo comparator arm

Locations

Country	Name	City	State
Netherlands	Metabolic Research Unit Maastricht	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Cognitive performance	Quantified through the Cambridge Neuropsychological Test Automated Battery (CANTAB).	Change after 6 weeks of intervention