Cognitive DysfunctionNCT07750223
Cognitive Effects of Hesperidin in Overweight/Obese Older Adults
A study testing Hesperidin in people with Cognitive Dysfunction and Overweight and Obesity, run by Min Hou at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Cognitive Dysfunction, Overweight and Obesity
- What is being tested?
- Hesperidin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 55-75 years
- BMI ≥ 24 kg/m² or waist circumference ≥ 90 cm (men) / ≥ 85 cm (women)
- Willing to participate and sign informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Community Health Centers in Shanghai
Shanghai, Shanghai Municipality, 200030
ShiQi Lin, 86 18616825727, olinalin@sjtu.edu.cn
About this study
Official title: A Randomized Controlled Trial of Hesperidin for Improving Cognitive Function in Overweight and Obese Middle-Aged and 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).
Read more
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.
- Conditions
- Cognitive Dysfunction, Overweight and Obesity
- Being tested
- Hesperidin
- Keywords
- Hesperidin, Cognitive Function, Citrus Flavonoids, Gut Microbiota, Nutritional Intervention, Middle-aged and Elderly, Randomized Controlled Trial
- Medical subject headings
- Cognitive Dysfunction, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HesperidinDietary supplement
Also called Citrus Flavonoid
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).
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | 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. Receives: Dietary Supplement: Hesperidin |
| Low-Dose Hesperidin Group | Experimental | Participants receive hesperidin 300 mg + corn starch 300 mg (total 600 mg) daily, taken as 2 capsules for 10 weeks. Receives: Dietary Supplement: Hesperidin |
| High-Dose Hesperidin Group | Experimental | Participants receive hesperidin 600 mg daily, taken as 2 capsules for 10 weeks. Receives: Dietary Supplement: Hesperidin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 10
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.
Measured: Baseline to Week 10
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).
Measured: Baseline to Week 10
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.
Measured: Baseline to Week 10
Change in Cognitive Function Assessed by the Digit Symbol Substitution Test (DSST)
Unit of Measur is Number of correct responses. Higher scores indicate better processing speed, sustained attention, and working memory.
Measured: Baseline to Week 10
hange in Cognitive Function Assessed by the Wechsler Memory Scale (WMS)
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.
Measured: Baseline to Week 10
Secondary outcomes (5)
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).
Measured: Baseline to Week 10
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.
Measured: Baseline to Week 10
Change in Body Weight
Change in body weight measured using standard anthropometric procedures, reported in kilograms (kg); reduction indicates improvement in weight status.
Measured: Baseline to Week 10
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.
Measured: Baseline to Week 10
Change in Body Mass Index (BMI)
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.
Measured: Baseline to Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Feb 2026
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three parallel arms: placebo, 300 mg/day hesperidin, and 600 mg/day hesperidin.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min Hou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Min Hou, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750223
- Sponsor's protocol ID
- SJTU-PH-HESPERIDIN-2026
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Farag S, Tsang C, Al-Dujaili EAS, Murphy PN. Effect of Polyphenol Supplementation on Memory Functioning in Overweight and Obese Adults: A Systematic Review and Meta-Analysis. Nutrients. 2024 Feb 6;16(4):474. doi: 10.3390/nu16040474.
PubMed 38398799Kean RJ, Lamport DJ, Dodd GF, Freeman JE, Williams CM, Ellis JA, Butler LT, Spencer JP. Chronic consumption of flavanone-rich orange juice is associated with cognitive benefits: an 8-wk, randomized, double-blind, placebo-controlled trial in healthy older adults. Am J Clin Nutr. 2015 Mar;101(3):506-14. doi: 10.3945/ajcn.114.088518. Epub 2015 Jan 14.
PubMed 25733635Hong Y, An Z. Hesperidin attenuates learning and memory deficits in APP/PS1 mice through activation of Akt/Nrf2 signaling and inhibition of RAGE/NF-kappaB signaling. Arch Pharm Res. 2018 Jun;41(6):655-663. doi: 10.1007/s12272-015-0662-z. Epub 2015 Sep 21.
PubMed 26391026Wang D, Liu L, Zhu X, Wu W, Wang Y. Hesperidin alleviates cognitive impairment, mitochondrial dysfunction and oxidative stress in a mouse model of Alzheimer's disease. Cell Mol Neurobiol. 2014 Nov;34(8):1209-21. doi: 10.1007/s10571-014-0098-x. Epub 2014 Aug 19.
PubMed 25135708Lamport DJ, Pal D, Macready AL, Barbosa-Boucas S, Fletcher JM, Williams CM, Spencer JP, Butler LT. The effects of flavanone-rich citrus juice on cognitive function and cerebral blood flow: an acute, randomised, placebo-controlled cross-over trial in healthy, young adults. Br J Nutr. 2016 Dec;116(12):2160-2168. doi: 10.1017/S000711451600430X. Epub 2017 Jan 16.
PubMed 28091350
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Hesperidin for Improving Cognitive Function in Overweight and Obese Middle-Aged and Older Adults
- ClinicalTrials.gov ID
- NCT07750223
- Acronym / sponsor ID
- SJTU-PH-HESPERIDIN-2026
- Conditions
- Cognitive Dysfunction, Overweight and Obesity
- Keywords
- Hesperidin, Cognitive Function, Citrus Flavonoids, Gut Microbiota, Nutritional Intervention, Middle-aged and Elderly, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Min HouUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three parallel arms: placebo, 300 mg/day hesperidin, and 600 mg/day hesperidin.
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Dietary Supplement: HesperidinParticipants receive 2 placebo capsules (corn starch 600 mg/day) daily for 10 weeks. Capsules are identical in appearance, smell, and packaging to hesperidin capsules. |
| Low-Dose Hesperidin Group | Experimental | Dietary Supplement: HesperidinParticipants receive hesperidin 300 mg + corn starch 300 mg (total 600 mg) daily, taken as 2 capsules for 10 weeks. |
| High-Dose Hesperidin Group | Experimental | Dietary Supplement: HesperidinParticipants receive hesperidin 600 mg daily, taken as 2 capsules for 10 weeks. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 55-75 years
- BMI ≥ 24 kg/m² or waist circumference ≥ 90 cm (men) / ≥ 85 cm (women)
- Willing to participate and sign informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HesperidinAlso: Citrus FlavonoidOral 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). | Dietary supplement | High-Dose Hesperidin Group, Low-Dose Hesperidin Group, Placebo Group |
Primary outcome
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.
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.
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).
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.
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.
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.
5 secondary outcomes
Change in Gut Microbiota Composition
Time frame: Baseline to Week 10
Change in Inflammatory Markers (TNF-α, IL-6, CRP)
Time frame: Baseline to Week 10
Change in Body Weight
Time frame: Baseline to Week 10
Change in Waist Circumference
Time frame: Baseline to Week 10
Change in Body Mass Index (BMI)
Time frame: Baseline to Week 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Background: PubMed 38398799Farag S, Tsang C, Al-Dujaili EAS, Murphy PN. Effect of Polyphenol Supplementation on Memory Functioning in Overweight and Obese Adults: A Systematic Review and Meta-Analysis. Nutrients. 2024 Feb 6;16(4):474. doi: 10.3390/nu16040474.
- Background: PubMed 25733635Kean RJ, Lamport DJ, Dodd GF, Freeman JE, Williams CM, Ellis JA, Butler LT, Spencer JP. Chronic consumption of flavanone-rich orange juice is associated with cognitive benefits: an 8-wk, randomized, double-blind, placebo-controlled trial in healthy older adults. Am J Clin Nutr. 2015 Mar;101(3):506-14. doi: 10.3945/ajcn.114.088518. Epub 2015 Jan 14.
- Background: PubMed 26391026Hong Y, An Z. Hesperidin attenuates learning and memory deficits in APP/PS1 mice through activation of Akt/Nrf2 signaling and inhibition of RAGE/NF-kappaB signaling. Arch Pharm Res. 2018 Jun;41(6):655-663. doi: 10.1007/s12272-015-0662-z. Epub 2015 Sep 21.
- Background: PubMed 25135708Wang D, Liu L, Zhu X, Wu W, Wang Y. Hesperidin alleviates cognitive impairment, mitochondrial dysfunction and oxidative stress in a mouse model of Alzheimer's disease. Cell Mol Neurobiol. 2014 Nov;34(8):1209-21. doi: 10.1007/s10571-014-0098-x. Epub 2014 Aug 19.
- Background: PubMed 28091350Lamport DJ, Pal D, Macready AL, Barbosa-Boucas S, Fletcher JM, Williams CM, Spencer JP, Butler LT. The effects of flavanone-rich citrus juice on cognitive function and cerebral blood flow: an acute, randomised, placebo-controlled cross-over trial in healthy, young adults. Br J Nutr. 2016 Dec;116(12):2160-2168. doi: 10.1017/S000711451600430X. Epub 2017 Jan 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hesperidin in people with Cognitive Dysfunction and Overweight and Obesity, run by Min Hou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Hou (13121858610, minhou@sjtu.edu.cna), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive Function Assessed by the Mini-Mental State Examination (MMSE) (time frame: Baseline to Week 10). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07750223, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.