Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07750223

Cognitive Effects of Hesperidin in Overweight/Obese Older Adults

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community Health Centers in Shanghai

Shanghai, Shanghai Municipality, 200030, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Citrus Flavonoid

Primary outcomes

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

    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.

  2. Change in Cognitive Function Assessed by the Montreal Cognitive Assessment (MoCA)

    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.

  3. Change in Cognitive Function Assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)

    Time frame: Baseline to Week 10

    Units on a Scale (0 to 30 points). Higher scores indicate worse cognitive function (greater impairment).

  4. Change in Cognitive Function Assessed by the Trail Making Test (TMT)

    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.

  5. Change in Cognitive Function Assessed by the Digit Symbol Substitution Test (DSST)

    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.

  6. hange in Cognitive Function Assessed by the Wechsler Memory Scale (WMS)

    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.

Secondary outcomes

  1. Change in Gut Microbiota Composition

    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).

  2. Change in Inflammatory Markers (TNF-α, IL-6, CRP)

    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.

  3. Change in Body Weight

    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.

  4. Change in Waist Circumference

    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.

  5. Change in Body Mass Index (BMI)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Min Hou

CONTACT

[email protected]

13121858610

ShiQi Lin

CONTACT

[email protected]

18616825727

Sponsors and collaborators

Lead sponsor

Min Hou

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

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.

Published trials that share one or more normalized conditions with this study.