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Brain Insulin-sensitivityNCT07177781

Effects of Wild Blueberry Consumption on Brain Function in Elderly

A study testing Wild blueberry powder in people with Brain Insulin-sensitivity and Brain Vascular Function, run by Maastricht University Medical Center at 1 site in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 75 yearsHealthy volunteers can take part
What is being tested?
Wild blueberry powder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteNetherlands
Study dates
5 Dec 2024to 31 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • Allergy or intolerance to berries
  • Left-handedness
  • Current smoker, or smoking cessation < 12 months
  • Diabetic patients
  • Familial hypercholesterolemia
  • Abuse of drugs
Show all 13Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Netherlands1 site, 1 recruiting
  • Maastricht University, Departement of Nutrition and Movement Sciences

    Maastricht, Limburg, 6200 MD

    Peter P.J. Joris, PhD, 0031883887250, p.joris@maastrichtuniversity.nl

    Tineke Degens, MSc, 00433883547, tineke.degens@maastrichtuniversity.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: Longer-term Effects of Wild Blueberry Consumption on Brain Function in Older Men and Women

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).

Being tested
Wild blueberry powder
Keywords
Cognitive performance, Brain insulin-resistance, Brain vascular function, Cerebral blood flow, Wild blueberry, Brain insulin-sensitivity, Anthocyanin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wild blueberry powderDietary 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.

Study groups in NCT07177781
Study groupRoleWhat they receive
Matched placeboNo interventionAdults 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.
Wild blueberry powder (wild blueberry intervention)ExperimentalThe 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
Receives: Dietary Supplement: Wild blueberry powder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MRI-brain perfusion measurement Arterial Spin Labeling

    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).

    Measured: Change in brain perfusion at the end of a 16-week wild blueberry intervention and a 16-week control period with a matched placebo.

Secondary outcomes (2)
  1. Cognitive performance measurement by Cambridge Neuropsychological Test Automated Battery

    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.

    Measured: Change in cognitive performance at the end of a 16-week wild blueberry intervention and a 16-week control period with a matched placebo.

  2. Brain Insulin Sensitivity

    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).

    Measured: Change in outcomes at the end of a 16-week wild blueberry intervention and 16-week control period with a matched placebo.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2025
  2. Study start5 Dec 2024
  3. Primary completionJun 2026 (estimated)
  4. Study completion31 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07177781
Sponsor's protocol ID
METC 24-040
Status last verified
Nov 2024
First submitted
12 Nov 2024
Last updated
17 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Wolters FJ, Zonneveld HI, Hofman A, van der Lugt A, Koudstaal PJ, Vernooij MW, Ikram MA; Heart-Brain Connection Collaborative Research Group. Cerebral Perfusion and the Risk of Dementia: A Population-Based Study. Circulation. 2017 Aug 22;136(8):719-728. doi: 10.1161/CIRCULATIONAHA.117.027448. Epub 2017 Jun 6.

    PubMed 28588075
  • Ahles S, Stevens YR, Joris PJ, Vauzour D, Adam J, de Groot E, Plat J. The Effect of Long-Term Aronia melanocarpa Extract Supplementation on Cognitive Performance, Mood, and Vascular Function: A Randomized Controlled Trial in Healthy, Middle-Aged Individuals. Nutrients. 2020 Aug 17;12(8):2475. doi: 10.3390/nu12082475.

    PubMed 32824483
  • Ivanov D, Gardumi A, Haast RAM, Pfeuffer J, Poser BA, Uludag K. Comparison of 3T and 7T ASL techniques for concurrent functional perfusion and BOLD studies. Neuroimage. 2017 Aug 1;156:363-376. doi: 10.1016/j.neuroimage.2017.05.038. Epub 2017 May 19.

    PubMed 28528845
  • Kullmann S, Veit R, Peter A, Pohmann R, Scheffler K, Haring HU, Fritsche A, Preissl H, Heni M. Dose-Dependent Effects of Intranasal Insulin on Resting-State Brain Activity. J Clin Endocrinol Metab. 2018 Jan 1;103(1):253-262. doi: 10.1210/jc.2017-01976.

    PubMed 29095982
  • Alsop DC, Detre JA, Golay X, Gunther M, Hendrikse J, Hernandez-Garcia L, Lu H, MacIntosh BJ, Parkes LM, Smits M, van Osch MJ, Wang DJ, Wong EC, Zaharchuk G. Recommended implementation of arterial spin-labeled perfusion MRI for clinical applications: A consensus of the ISMRM perfusion study group and the European consortium for ASL in dementia. Magn Reson Med. 2015 Jan;73(1):102-16. doi: 10.1002/mrm.25197. Epub 2014 Apr 8.

    PubMed 24715426
  • Azari H, Morovati A, Pourghassem Gargari B, Sarbakhsh P. Beneficial effects of blueberry supplementation on the components of metabolic syndrome: a systematic review and meta-analysis. Food Funct. 2022 May 10;13(9):4875-4900. doi: 10.1039/d1fo03715c.

    PubMed 35445669
  • Joris PJ, Plat J, Bakker SJ, Mensink RP. Long-term magnesium supplementation improves arterial stiffness in overweight and obese adults: results of a randomized, double-blind, placebo-controlled intervention trial. Am J Clin Nutr. 2016 May;103(5):1260-6. doi: 10.3945/ajcn.116.131466. Epub 2016 Apr 6.

    PubMed 27053384
  • Joris PJ, Plat J, Kusters YH, Houben AJ, Stehouwer CD, Schalkwijk CG, Mensink RP. Diet-induced weight loss improves not only cardiometabolic risk markers but also markers of vascular function: a randomized controlled trial in abdominally obese men. Am J Clin Nutr. 2017 Jan;105(1):23-31. doi: 10.3945/ajcn.116.143552. Epub 2016 Nov 23.

    PubMed 27881395
  • Nijssen KMR, Mensink RP, Plat J, Joris PJ. Longer-term mixed nut consumption improves brain vascular function and memory: A randomized, controlled crossover trial in older adults. Clin Nutr. 2023 Jul;42(7):1067-1075. doi: 10.1016/j.clnu.2023.05.025. Epub 2023 Jun 3.

    PubMed 37296019
  • Tischmann L, Adam TC, Mensink RP, Joris PJ. Longer-term soy nut consumption improves vascular function and cardiometabolic risk markers in older adults: Results of a randomized, controlled cross-over trial. Clin Nutr. 2022 May;41(5):1052-1058. doi: 10.1016/j.clnu.2022.03.014. Epub 2022 Mar 14.

    PubMed 35395555
  • Nijssen KM, Mensink RP, Plat J, Ivanov D, Preissl H, Joris PJ. Mixed nut consumption improves brain insulin sensitivity: a randomized, single-blinded, controlled, crossover trial in older adults with overweight or obesity. Am J Clin Nutr. 2024 Feb;119(2):314-323. doi: 10.1016/j.ajcnut.2023.12.010. Epub 2023 Dec 20.

    PubMed 38128733
  • Kleinloog JPD, Mensink RP, Smeets ETHC, Ivanov D, Joris PJ. Acute inorganic nitrate intake increases regional insulin action in the brain: Results of a double-blind, randomized, controlled cross-over trial with abdominally obese men. Neuroimage Clin. 2022;35:103115. doi: 10.1016/j.nicl.2022.103115. Epub 2022 Jul 14.

    PubMed 35843050
  • Nijssen KMR, Mensink RP, Joris PJ. Effects of Intranasal Insulin Administration on Cerebral Blood Flow and Cognitive Performance in Adults: A Systematic Review of Randomized, Placebo-Controlled Intervention Studies. Neuroendocrinology. 2023;113(1):1-13. doi: 10.1159/000526717. Epub 2022 Aug 24.

    PubMed 36219990
  • Kleinloog JPD, Tischmann L, Mensink RP, Adam TC, Joris PJ. Longer-term soy nut consumption improves cerebral blood flow and psychomotor speed: results of a randomized, controlled crossover trial in older men and women. Am J Clin Nutr. 2021 Dec 1;114(6):2097-2106. doi: 10.1093/ajcn/nqab289.

    PubMed 34510189
  • Rees A, Dodd GF, Spencer JPE. The Effects of Flavonoids on Cardiovascular Health: A Review of Human Intervention Trials and Implications for Cerebrovascular Function. Nutrients. 2018 Dec 1;10(12):1852. doi: 10.3390/nu10121852.

    PubMed 30513729

Questions about this trial

What is this clinical trial studying?

A study testing Wild blueberry powder in people with Brain Insulin-sensitivity and Brain Vascular Function, run by Maastricht University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Peter P.J. Joris, PhD (0031883887250, p.joris@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRI-brain perfusion measurement Arterial Spin Labeling (time frame: Change in brain perfusion at the end of a 16-week wild blueberry intervention and a 16-week control period with a matched placebo.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07177781, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.

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