Cognitive Effects of Hesperidin in Overweight/Obese Older Adults

Официальное название

A Randomized Controlled Trial of Hesperidin for Improving Cognitive Function in Overweight and Obese Middle-Aged and Older Adults

Обзор

A randomized, double-blind, placebo-controlled trial was designed to test whether two doses of hesperidin (a natural flavonoid from citrus fruits) improve cognitive function in overweight and obese older adults. A total of 105 participants, aged 55-75 years with a BMI ≥24 kg/m² or elevated waist circumference, will be randomly assigned to one of three 10-week treatments: placebo, low-dose hesperidin (300 mg/day), or high-dose hesperidin (600 mg/day). The primary aim is to see if hesperidin supplementation enhances cognitive performance - specifically executive function, memory, and attention - and to explore any dose-response relationship. Secondary aims include examining changes in gut microbiota composition and related metabolites, as well as exploring potential mechanisms behind any observed effects. The findings are expected to provide scientific evidence on whether hesperidin could serve as a nutritional strategy to support cognitive health in this population.

Вмешательства

• Пищевая добавка Hesperidin
  Oral hesperidin supplementation or matching placebo, administered as 2 capsules per day for 10 weeks. * Placebo Comparator: corn starch 600 mg/day * Low-dose: hesperidin 300 mg + corn starch 300 mg/day (total 600 mg) * High-dose: hesperidin 600 mg/day All capsules are identical in appearance, color, smell, taste, and packaging to maintain blinding. All participants undergo scheduled assessments: physical measurements (weeks 2,4,6,8), 24h dietary recall and IPAQ (every 2 weeks), weekly urine s

Первичные конечные точки

• Change in Cognitive Function Assessed by the Mini-Mental State Examination (MMSE) [Срок оценки: Baseline to Week 10]
• Change in Cognitive Function Assessed by the Montreal Cognitive Assessment (MoCA) [Срок оценки: Baseline to Week 10]
• Change in Cognitive Function Assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) [Срок оценки: Baseline to Week 10]
• Change in Cognitive Function Assessed by the Trail Making Test (TMT) [Срок оценки: Baseline to Week 10]
• Change in Cognitive Function Assessed by the Digit Symbol Substitution Test (DSST) [Срок оценки: Baseline to Week 10]
• hange in Cognitive Function Assessed by the Wechsler Memory Scale (WMS) [Срок оценки: Baseline to Week 10]

Вторичные конечные точки (5)

• Change in Gut Microbiota Composition [Срок оценки: Baseline to Week 10]
• Change in Inflammatory Markers (TNF-α, IL-6, CRP) [Срок оценки: Baseline to Week 10]
• Change in Body Weight [Срок оценки: Baseline to Week 10]
• Change in Waist Circumference [Срок оценки: Baseline to Week 10]
• Change in Body Mass Index (BMI) [Срок оценки: Baseline to Week 10]

Критерии участия

Критерии включения

• Age 55-75 years
• BMI ≥ 24 kg/m² or waist circumference ≥ 90 cm (men) / ≥ 85 cm (women)
• Willing to participate and sign informed consent

Критерии исключения

• MMSE score < 20
• History of neurological diseases (Parkinson's, Alzheimer's, stroke, etc.)
• Malignant tumors, severe liver/kidney/gastrointestinal diseases
• Use of weight-loss drugs or antidepressants (except statins) within recent months
• Strict vegetarians, binge eating disorder, heavy alcohol consumption
• Participation in other intervention studies
• Other conditions judged by investigators as unsuitable

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Community Health Centers in Shanghai — Шанхай

Публикации

• Farag S, Tsang C, Al-Dujaili EAS, Murphy PN. Effect of Polyphenol Supplementation on Memory Functioning in Overweight and Obese Adults: A Systematic Review and Meta-Analysis. Nutrients. 2024 Feb 6;16(4):474. doi: 10.3390/nu16040474. PMID 38398799
• Kean RJ, Lamport DJ, Dodd GF, Freeman JE, Williams CM, Ellis JA, Butler LT, Spencer JP. Chronic consumption of flavanone-rich orange juice is associated with cognitive benefits: an 8-wk, randomized, double-blind, placebo-controlled trial in healthy older adults. Am J Clin Nutr. 2015 Mar;101(3):506-14. doi: 10.3945/ajcn.114.088518. Epub 2015 Jan 14. PMID 25733635
• Hong Y, An Z. Hesperidin attenuates learning and memory deficits in APP/PS1 mice through activation of Akt/Nrf2 signaling and inhibition of RAGE/NF-kappaB signaling. Arch Pharm Res. 2018 Jun;41(6):655-663. doi: 10.1007/s12272-015-0662-z. Epub 2015 Sep 21. PMID 26391026
• Wang D, Liu L, Zhu X, Wu W, Wang Y. Hesperidin alleviates cognitive impairment, mitochondrial dysfunction and oxidative stress in a mouse model of Alzheimer's disease. Cell Mol Neurobiol. 2014 Nov;34(8):1209-21. doi: 10.1007/s10571-014-0098-x. Epub 2014 Aug 19. PMID 25135708
• Lamport DJ, Pal D, Macready AL, Barbosa-Boucas S, Fletcher JM, Williams CM, Spencer JP, Butler LT. The effects of flavanone-rich citrus juice on cognitive function and cerebral blood flow: an acute, randomised, placebo-controlled cross-over trial in healthy, young adults. Br J Nutr. 2016 Dec;116(12):2160-2168. doi: 10.1017/S000711451600430X. Epub 2017 Jan 16. PMID 28091350

Идентификаторы

NCT: NCT07750223 · SJTU-PH-HESPERIDIN-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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