Cognitive Effects of Hesperidin in Overweight/Obese Older Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-75
SponsorMin Hou
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 55-75 years
BMI ≥ 24 kg/m² or waist circumference ≥ 90 cm (men) / ≥ 85 cm (women)
Willing to participate and sign informed consent
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Hesperidin
Dietary supplementOral 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).
Treatment groups
105 Participants
are divided into 3 treatment groupsGroup A: Placebo GroupPlacebo comparator 1 intervention
Group B: Low-Dose Hesperidin GroupExperimental treatment 1 intervention
Group C: High-Dose Hesperidin GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Cognitive Function Assessed by the Mini-Mental State Examination (MMSE)
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 102
Change in Cognitive Function Assessed by the Montreal Cognitive Assessment (MoCA)
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 103
Change in Cognitive Function Assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Units on a Scale (0 to 30 points). Higher scores indicate worse cognitive function (greater impairment).
Time frame
Baseline to Week 104
Change in Cognitive Function Assessed by the Trail Making Test (TMT)
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 10Secondary outcomes
1
Change in Gut Microbiota Composition
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 102
Change in Inflammatory Markers (TNF-α, IL-6, CRP)
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 103
Change in Body Weight
Change in body weight measured using standard anthropometric procedures, reported in kilograms (kg); reduction indicates improvement in weight status.
Time frame
Baseline to Week 104
Change in Waist Circumference
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 10Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Min Hou
Lead sponsor
University of Glasgow
Sponsor institution
Source ClinicalTrials.gov