Use Muscadine Wine Nutraceuticals to Improve Brain Health, Cognition, and Mental Health

Официальное название

Acute and Chronic Impacts of Muscadine Wine Polyphenols on Cognition, Memory, Mood, and Anxiety in Adults Over 50 Years of Age

Обзор

Previous studies have shown that polyphenol-rich foods can positively affect cognitive functions, memory, and mood in humans. We hypothesize that both acute and chronic intake of muscadine wine polyphenols will improve cognitive performance and mood through regulating the HPA axis, alleviating inflammation and oxidative stress, and/or inhibiting monoamine oxidase activities

Подробное описание

Although the exact biological mechanisms for depression and Alzheimer's Disease are not fully understood, it's believed that they are caused by a combination of factors. An increasing amount of scientific research has proposed several possible pathophysiologies linking depression and AD. For example, increased production of pro-inflammatory cytokines in the nervous system, oxidative stress induced by chronic inflammation leads to dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis, and disturbance in the brain-derived neurotrophic factor signal pathway. Polyphenol has been well recognized for its antioxidant and anti-inflammatory properties. Previous studies have shown that polyphenol-rich food such as concord grape juice, blueberries, blackcurrants, and green oats positively affect cognition, memory, and mood in humans. However, no one has examined the effects of muscadine wine polyphenol on cognitive and mental health. In addition, if they do have effects, through what mechanism? This clinical trial will allow us to investigate the questions raised. We hypothesize that intake of muscadine wine polyphenols enhances cognition and memory and improve depression and anxiety in healthy adults over 50 year-old via regulating the HPA axis, alleviating inflammation and oxidative stress, and/or inhibiting monoamine oxidase activities. The research will provide the first clinical evidence of how muscadine wine polyphenols affect the brain and mental health.

Вмешательства

• Другое Muscadine Wine Polyphenol
  dealcoholized muscadine wine with alcohol content \<0.5% with addition of 50ppm of sodium metabisulfite for preservation
• Другое Placebo
  this placebo beverage is formulated with matching sugar and organic acid content to the muscadine wine polyphenol. Food coloring is added to match the color of the intervention. 50ppm of sodium metabisulfite for preservation

Первичные конечные точки

• Change from baseline cognitive performance score after intervention/placebo [Срок оценки: Baseline, acute (4-hour post single dose), chronic (end of six week)]
• Change from baseline cognitive performance score after intervention/placebo - continued [Срок оценки: Baseline, acute (4-hour post single dose), chronic (end of six week)]
• Change from baseline cognitive performance score after intervention/placebo - continued [Срок оценки: Baseline, acute (4-hour post single dose), chronic (end of six week)]
• Change from baseline monoamine oxidase (MAOs) activity [Срок оценки: Baseline, acute (4-hour post single dose), chronic (end of six week)]
• Change from baseline neurotransmitters [Срок оценки: Baseline, acute (4-hour post single dose), chronic (end of six week)]
• Change from baseline brain-derived neurotrophic factors [Срок оценки: Baseline, acute (4-hour post single dose), chronic (end of six week)]
• Change from baseline cortisol, TNF-α, high sensitivity C-reactive protein, and LPS binding protein [Срок оценки: Baseline, acute (4-hour post single dose), chronic (end of six week)]

Вторичные конечные точки (3)

• Change from baseline mood and anxiety score after intervention/placebo [Срок оценки: Baseline, acute (4-hour post single dose), chronic (end of six week)]
• Change from baseline depression score after intervention/placebo [Срок оценки: Baseline, acute (4-hour post single dose), chronic (end of six week)]
• Change from baseline pro-inflammatory cytokines [Срок оценки: Baseline, acute (4-hour post single dose), chronic (end of six week)]

Критерии участия

Критерии включения

• Healthy
• BMI (18.5-29.9)
• Body weight ≥110 pounds

Критерии исключения

• Pregnancy
• Breast-feeding
• Smokers
• Diabetic
• Heavy drinkers
• Subjective but not clinically diagnosed cognitive impairment (Montreal cognitive assessment score <26),
• Inability to understand the cognitive function tasks
• Intake of medication that might influence the outcome of the study (e.g. psychostimulant)
• cannabis product user
• Clinically diagnosed mental illnesses
• Cardiovascular and neurological disorders
• Uncontrolled hypertension

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

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Food Science and human nutrition department at University of Florida — Gainesville

Публикации

• Menard C, Pfau ML, Hodes GE, Kana V, Wang VX, Bouchard S, Takahashi A, Flanigan ME, Aleyasin H, LeClair KB, Janssen WG, Labonte B, Parise EM, Lorsch ZS, Golden SA, Heshmati M, Tamminga C, Turecki G, Campbell M, Fayad ZA, Tang CY, Merad M, Russo SJ. Social stress induces neurovascular pathology promoting depression. Nat Neurosci. 2017 Dec;20(12):1752-1760. doi: 10.1038/s41593-017-0010-3. Epub 2017 PMID 29184215
• Du X, Pang TY. Is Dysregulation of the HPA-Axis a Core Pathophysiology Mediating Co-Morbid Depression in Neurodegenerative Diseases? Front Psychiatry. 2015 Mar 9;6:32. doi: 10.3389/fpsyt.2015.00032. eCollection 2015. PMID 25806005
• Haskell-Ramsay CF, Stuart RC, Okello EJ, Watson AW. Cognitive and mood improvements following acute supplementation with purple grape juice in healthy young adults. Eur J Nutr. 2017 Dec;56(8):2621-2631. doi: 10.1007/s00394-017-1454-7. Epub 2017 Apr 20. PMID 28429081
• Lamport DJ, Lawton CL, Merat N, Jamson H, Myrissa K, Hofman D, Chadwick HK, Quadt F, Wightman JD, Dye L. Concord grape juice, cognitive function, and driving performance: a 12-wk, placebo-controlled, randomized crossover trial in mothers of preteen children. Am J Clin Nutr. 2016 Mar;103(3):775-83. doi: 10.3945/ajcn.115.114553. Epub 2016 Feb 10. PMID 26864371
• Whyte AR, Schafer G, Williams CM. Cognitive effects following acute wild blueberry supplementation in 7- to 10-year-old children. Eur J Nutr. 2016 Sep;55(6):2151-62. doi: 10.1007/s00394-015-1029-4. Epub 2015 Oct 5. PMID 26437830
• Watson AW, Haskell-Ramsay CF, Kennedy DO, Cooney JM, Trower T, Scheepens A. Acute supplementation with blackcurrant extracts modulates cognitive functioning and inhibits monoamine oxidase-B in healthy young adults. Journal of Functional Food. 2015 Aug;17:524-539. doi:10.1016/j.jff.2015.06.005
• Kennedy DO, Bonnlander B, Lang SC, Pischel I, Forster J, Khan J, Jackson PA, Wightman EL. Acute and Chronic Effects of Green Oat (Avena sativa) Extract on Cognitive Function and Mood during a Laboratory Stressor in Healthy Adults: A Randomised, Double-Blind, Placebo-Controlled Study in Healthy Humans. Nutrients. 2020 May 29;12(6):1598. doi: 10.3390/nu12061598. PMID 32485993
• Bandaruk Y, Mukai R, Kawamura T, Nemoto H, Terao J. Evaluation of the inhibitory effects of quercetin-related flavonoids and tea catechins on the monoamine oxidase-A reaction in mouse brain mitochondria. J Agric Food Chem. 2012 Oct 17;60(41):10270-7. doi: 10.1021/jf303055b. Epub 2012 Oct 8. PMID 23009399

Идентификаторы

NCT: NCT05541887 · IRB202300014

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗