Effects of Wild Blueberry Consumption on Brain Function in Elderly

Not Applicable

Recruiting

• Conditions: Brain Insulin-sensitivity; Brain Vascular Function; Cerebral Blood Flow

• Registration Number: NCT07177781
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-12
• Study Start: 2024-12-05
• Study First Submitted QC: 2025-09-10
• Last Update Submitted: 2025-09-10
• Study First Posted: 2025-09-17
• Last Update Posted: 2025-09-17
• Primary Completion: 2026-06
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
MRI-brain perfusion measurement Arterial Spin Labeling	Change in brain perfusion at the end of a 16-week wild blueberry intervention and a 16-week control period with a matched placebo.	Cerebral blood flow responses before (brain vascular function) and after the administration of intranasal insulin (brain insulin-sensitivity) will be non-invasively quantified by MRI-perfusion method Arterial Spin Labeling (ASL).

Secondary Outcome Measures

Name	Time	Method
Cognitive performance measurement by Cambridge Neuropsychological Test Automated Battery	Change in cognitive performance at the end of a 16-week wild blueberry intervention and a 16-week control period with a matched placebo.	Cognitive performance will be investigated using Cambridge Neuropsychological Test Automated Battery (CANTAB), which will be performed on an Ipad. The cognitive task performance will be tested in three important cognitive domains namely attention, memory and executive function. Learning effects are prevented by randomization of the intervention periods and the settings of CANTAB, including parallel modes and stimuli randomization. The test will be performed in Dutch.
Brain Insulin Sensitivity	Change in outcomes at the end of a 16-week wild blueberry intervention and 16-week control period with a matched placebo.	Change in cerebral blood flow, as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL), before and after application of intranasal insulin (160 IU).

Trial Locations

Locations (1)

Maastricht University, Departement of Nutrition and Movement Sciences; 🇳🇱 Maastricht, Limburg, Netherlands