Effects of Wild Blueberry Consumption on Brain Function in Elderly

Официальное название

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

Обзор

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).

Вмешательства

• Пищевая добавка 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.

Первичные конечные точки

• MRI-brain perfusion measurement Arterial Spin Labeling [Срок оценки: Change in brain perfusion at the end of a 16-week wild blueberry intervention and a 16-week control period with a matched placebo.]

Вторичные конечные точки (2)

• Cognitive performance measurement by Cambridge Neuropsychological Test Automated Battery [Срок оценки: Change in cognitive performance at the end of a 16-week wild blueberry intervention and a 16-week control period with a matched placebo.]
• Brain Insulin Sensitivity [Срок оценки: Change in outcomes at the end of a 16-week wild blueberry intervention and 16-week control period with a matched placebo.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Нидерланды · 1 центр

• Maastricht University, Departement of Nutrition and Movement Sciences — Maastricht

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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/mr PMID 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. PMID 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. PMID 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. PMID 27881395

Идентификаторы

NCT: NCT07177781 · METC 24-040

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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