A Randomized Controlled Trial of Hesperidin for Improving Cognitive Function in Overweight and Obese Middle-Aged and Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Change in Cognitive Function Assessed by the Mini-Mental State Examination (MMSE)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double-blind: Participants, investigators, and outcome assessors are blinded to group assignment.
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 55-75 years
- •BMI ≥ 24 kg/m² or waist circumference ≥ 90 cm (men) / ≥ 85 cm (women)
- •Willing to participate and sign informed consent
排除标准
- •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
研究组 & 干预措施
Placebo Group
Participants receive 2 placebo capsules (corn starch 600 mg/day) daily for 10 weeks. Capsules are identical in appearance, smell, and packaging to hesperidin capsules.
干预措施: Hesperidin (Dietary Supplement)
Low-Dose Hesperidin Group
Participants receive hesperidin 300 mg + corn starch 300 mg (total 600 mg) daily, taken as 2 capsules for 10 weeks.
干预措施: Hesperidin (Dietary Supplement)
High-Dose Hesperidin Group
Participants receive hesperidin 600 mg daily, taken as 2 capsules for 10 weeks.
干预措施: Hesperidin (Dietary Supplement)
结局指标
主要结局
Change in Cognitive Function Assessed by the Mini-Mental State Examination (MMSE)
时间窗: Baseline to Week 10
Units on a Scale (0 to 30 points).Higher scores indicate better cognitive function. Scores ≥25 are generally considered normal; scores \<24 suggest cognitive impairment.
Change in Cognitive Function Assessed by the Montreal Cognitive Assessment (MoCA)
时间窗: Baseline to Week 10
Units on a Scale (0 to 30 points).Higher scores indicate better cognitive function. Scores ≥26 are considered normal; scores 18-25 indicate mild cognitive impairment; scores 10-17 indicate moderate impairment; scores \<10 indicate severe impairment.
Change in Cognitive Function Assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
时间窗: Baseline to Week 10
Units on a Scale (0 to 30 points). Higher scores indicate worse cognitive function (greater impairment).
Change in Cognitive Function Assessed by the Trail Making Test (TMT)
时间窗: Baseline to Week 10
Unit of Measure is Seconds. Shorter completion times indicate better cognitive function. Part B assesses executive function and cognitive flexibility; a higher TMT-B/TMT-A ratio may indicate greater impairment.
Change in Cognitive Function Assessed by the Digit Symbol Substitution Test (DSST)
时间窗: Baseline to Week 10
Unit of Measur is Number of correct responses. Higher scores indicate better processing speed, sustained attention, and working memory.
hange in Cognitive Function Assessed by the Wechsler Memory Scale (WMS)
时间窗: Baseline to Week 10
Raw scores for each subtest are converted to scaled scores using norm tables; scaled scores are summed to obtain the full-scale score, which is then converted to a Memory Quotient (MQ) using norm tables.Higher scores indicate better memory function. The Memory Quotient (MQ) normally ranges from 80 to 120. Scores below 80 suggest below-average memory performance; scores above 120 suggest above-average memory performance.
次要结局
- Change in Gut Microbiota Composition(Baseline to Week 10)
- Change in Inflammatory Markers (TNF-α, IL-6, CRP)(Baseline to Week 10)
- Change in Body Weight(Baseline to Week 10)
- Change in Waist Circumference(Baseline to Week 10)
- Change in Body Mass Index (BMI)(Baseline to Week 10)
研究者
Min Hou
Associate Professor / Master's Thesis Advisor
University of Glasgow