Community Health Centers in Shanghai
Shanghai, Shanghai Municipality, 200030, China
Location status: Recruiting
NCT Number: NCT07750223
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.
Interested in participating?
Request Info55 year–75 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200030, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral hesperidin supplementation or matching placebo, administered as 2 capsules per day for 10 weeks.
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).
Other names: Citrus Flavonoid
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 10
Units on a Scale (0 to 30 points). Higher scores indicate worse cognitive function (greater impairment).
Time frame: 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.
Time frame: Baseline to Week 10
Unit of Measur is Number of correct responses. Higher scores indicate better processing speed, sustained attention, and working memory.
Time frame: 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.
Time frame: Baseline to Week 10
Changes in gut microbiota composition and diversity assessed by 16S rRNA sequencing or metagenomic analysis of fecal samples. Primary focus on alpha and beta diversity, and relative abundance of key bacterial taxa (e.g., Bifidobacterium, Lactobacillus, Akkermansia).
Time frame: Baseline to Week 10
Changes in serum levels of pro-inflammatory markers including tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), and C-reactive protein (CRP), measured by ELISA or multiplex assays.
Time frame: Baseline to Week 10
Change in body weight measured using standard anthropometric procedures, reported in kilograms (kg); reduction indicates improvement in weight status.
Time frame: Baseline to Week 10
Change in waist circumference measured using standard anthropometric procedures at the midpoint between the lowest rib and the iliac crest, reported in centimeters (cm); reduction indicates improvement in central adiposity.
Time frame: Baseline to Week 10
BMI calculated as body weight in kilograms divided by the square of height in meters (kg/m²). Height was measured at baseline only using standard anthropometric procedures. Reduction in BMI indicates improvement in overall adiposity. Per Chinese BMI classification standards: 24.0-27.9 kg/m² (overweight) and ≥28.0 kg/m² (obese); the study enrolled participants with BMI ≥ 24.0 kg/m².
Contact information is provided by the study sponsor or research team.
Min Hou
Other
A Randomized Controlled Trial of Hesperidin for Improving Cognitive Function in Overweight and Obese Middle-Aged and Older Adults
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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