Effects of Wild Blueberry Consumption on Brain Function in Elderly

NCT ID: NCT07177781

Last Updated: 2025-09-17

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-05

Study Completion Date

2026-08-31

Brief Summary

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Impaired brain vascular function precedes the development of reduced cognitive performance, while brain insulin-resistance is associated with cognitive decline. Evidence from epidemiological studies has already suggested beneficial effects of wild blueberry consumption on cognitive performance. However, underlying mechanisms have not yet been established, while well-controlled trials on longer-term effects of wild blueberries on cognitive performance are highly needed. This study hypothesizes that longer-term wild blueberry intake improves (regional) brain vascular function and insulin-sensitivity, thereby improving cognitive performance in older men and women. The primary objectives are to investigate in older adults the effect wild blueberry consumption on (regional) vascular function and insulin-sensitivity in the brain, and to focus on changes in cognitive performance as assessed with the CANTAB neuropsychological test battery (i.e., secondary objective). Cerebral blood flow responses before (brain vascular function) and after the administration of intranasal insulin spray (brain insulin-sensitivity) will be non-invasively quantified by the non-invasive gold standard magnetic resonance imaging (MRI)- perfusion method Arterial Spin Labeling (ASL).

Detailed Description

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Conditions

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Brain Insulin-sensitivity Brain Vascular Function Cerebral Blood Flow

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Double-blind, randomized, controlled cross-over design. Participants will receive, in a random order, daily 26 grams of wild blueberry powder or a matched placebo for sixteen weeks, separated by a washout period of at least 8 weeks.
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Matched placebo

Adults will receive in a random order, freeze-dried wild blueberry powder or a matched placebo for sixteen weeks, with a wash-out period of minimal eight weeks in-between. The placebo is an appearance, taste and macronutrient, fiber and vitamin C-matched powder containing blueberry flavoring and aroma, coloring, glucose, fructose, citric acid, ascorbic acid, cellulose, fibersol-2, xanthin gum, pectin, and silica. The placebo does not contain any form of anthocyanin that could potentially interfere with the wild blueberry intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Wild blueberry powder (wild blueberry intervention)

The wild blueberry intervention consist of 100% freeze-dried wild blueberry powder, containing anthocyanins. Participants will consume daily 26 grams of freeze-dried wild blueberry powders for 16 weeks. Participants should consume the powders by mixing them with water once daily in the morning

Group Type EXPERIMENTAL

Wild blueberry powder

Intervention Type DIETARY_SUPPLEMENT

Study volunteers will consume daily 26 grams of wild blueberry powder for 16 weeks, which has to be dissolved in a glass of water.

Interventions

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Wild blueberry powder

Study volunteers will consume daily 26 grams of wild blueberry powder for 16 weeks, which has to be dissolved in a glass of water.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Men and women, aged between 60-75 years
* BMI between 25-35 kg/m2 (overweight or obese)
* 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 evidences during the screening visit.

Exclusion Criteria

* Allergy or intolerance to berries
* Left-handedness
* Current smoker, or smoking cessation \< 12 months
* Diabetic patients
* Familial hypercholesterolemia
* Abuse of drugs
* More than 3 alcoholic consumptions per day
* Use of products or dietary supplements known to interfere with the main outcomes as judged by the principal investigators
* Use medication to treat blood pressure, lipid, or glucose metabolism
* Use of an investigational product within another biomedical intervention trial within the previous 1-month
* Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases, and rheumatoid arthritis.
* Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident.
* Contra-indications for MRI imaging (e.g., pacemaker, surgical clips/material in body, metal splinter in eye, claustrophobia)
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wild Blueberry Association of North America

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maastricht University, Departement of Nutrition and Movement Sciences

Maastricht, Limburg, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Peter P.J. Joris, PhD

Role: CONTACT

0031883887250

Tineke Degens, MSc

Role: CONTACT

0031433883547

Facility Contacts

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Peter P.J. Joris, PhD

Role: primary

0031883887250

Tineke Degens, MSc

Role: backup

00433883547

References

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Other Identifiers

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METC 24-040

Identifier Type: -

Identifier Source: org_study_id

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