Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2022-06-08
2023-08-25
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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Aronia
An aronia melanocarpa extract. Study volunteers will receive a daily oral dose of 160 mg AME for 6 weeks.
Aronia
As described in experimental arm
Control
Cellulose. Study volunteers will receive a daily oral dose of 160 mg cellulose for 6 weeks.
Control
As described in placebo comparator arm
Interventions
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Aronia
As described in experimental arm
Control
As described in placebo comparator arm
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
55 Years
75 Years
ALL
Yes
Sponsors
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Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Peter J Joris, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University
Locations
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Metabolic Research Unit Maastricht
Maastricht, , Netherlands
Countries
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Other Identifiers
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METC 21-084
Identifier Type: -
Identifier Source: org_study_id
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