Clinical trial

Cognitive Effects of Hesperidin in Overweight/Obese Older Adults

Recruiting now · Not applicable · 1 countries · Registry ID NCT07750223

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age55 Years to 75 Years

SexAll

Healthy volunteersNot accepted

ConditionCognitive Dysfunction, Overweight and Obesity

Full registry criteria

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

Treatments and study arms

Hesperidin

Dietary Supplement

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 samples, fecal samples (weeks 2,4,8,10), fasting blood samples (baseline and week 10), and bi-weekly nutrition education lectures (general health education only ,no dietary restriction).

Primary outcomes

Change in Cognitive Function Assessed by the Mini-Mental State Examination (MMSE)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)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)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)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)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)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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Community Health Centers in Shanghai🇨🇳 Shanghai, Shanghai Municipality, China

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ShiQi LinContact

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