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Cognitive ImpairmentNCT07152483

The Resistant Starch Intervention for Cognitive Enhancement

A study testing High resistant starch staple foods and Regular starch staple foods in people with Cognitive Impairment and Diet Interventions, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The investigation will explore the potential effects of resistant starch The Resistant Starch Intervention for Cognitive Enhancement study aimed to evaluate the effect of high-resistant starch diet intervention in slowing cognitive decline among individuals at high genetic risk for cognitive impairment. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
High resistant starch staple foods and Regular starch staple foods
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteChina
Study dates
1 Sep 2025to 1 Dec 2026
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged ≥ 40 years
  • meta-polygenic risk score (metaPRS) > 0.4
  • Montreal Cognitive Assessment (MoCA) score ≤ 26
  • Central obesity (waist circumference > 90 cm in males or > 80 cm in females) or body mass index (BMI) ≥ 28 kg/m²
  • Written informed consent available
  • Proficient in using smartphones
  • Willingness to complete all assessments and participate in follow-up

Who cannot join

  • Known hypersensitivity or allergy to resistant starch
  • previously diagnosed dementia
  • Suspected dementia after clinical assessment by study physician at screening visit
  • Previous history of major head trauma and any intracranial surgery
  • Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions
  • Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement
Show all 14Show fewer
  • Severe loss of vision, hearing, or communicative ability
  • Patients presenting a malignant disease with life expectancy < 3 years
  • Participation in an ongoing investigational drug study
  • The participant or a first-degree relative is currently participating in another clinical trial involving nutritional intervention.
  • Exit Criteria:
  • Not meet the inclusion criteria
  • For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator
  • Any adverse or serious adverse events during the study period judged by Investigator

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Min Lou, PhD, MD contact

13958007213

lm99@zju.edu.cn

China1 site

  • Second Affilated Hospital of Zhejiang University, School of Medicine

    Hangzhou, Zhejiang, 310009

    Min Lou, PhD, MD, 13958007213, lm99@zju.edu.cn

Other trials in China

About this study

Official title: The Resistant Starch Intervention for Cognitive Enhancement (RICE) in Individuals With High Genetic Risk

The investigation will explore the potential effects of resistant starch The Resistant Starch Intervention for Cognitive Enhancement study aimed to evaluate the effect of high-resistant starch diet intervention in slowing cognitive decline among individuals at high genetic risk for cognitive impairment. Participants will be randomly assigned to either an intervention group receiving daily high-resistant starch food products or a control group receiving isoenergetic regular starch products. The investigation will validate the potential effects of resistant starch on cognitive function protection and explore the underlying mechanisms through comprehensive data collection, including standardized neuropsychological assessments, laboratory biomarkers derived from blood and fecal specimens, and multimodal magnetic resonance imaging.

Read the detailed description

The Resistant Starch Intervention for Cognitive Enhancement (RICE) in Individuals With High Genetic Risk trial is designed to evaluate the effect of high-resistant starch diet intervention in slowing cognitive decline among individuals at high genetic risk for cognitive impairment. A total of 70 participants aged ≥40 years with a meta-polygenic risk score (metaPRS) >0.4-indicating elevated genetic susceptibility-and who are overweight or abdominally obese, will be randomly assigned in a 1:1 ratio to either an intervention group receiving daily high-resistant starch food products (≥28 g/day) or a control group receiving isoenergetic regular starch products. The investigation will validate the potential effects of resistant starch on cognitive function protection and explore the underlying mechanisms through comprehensive data collection, including standardized neuropsychological assessments, laboratory biomarkers derived from blood and fecal specimens, and multimodal magnetic resonance imaging.

Being tested
High resistant starch staple foods, Regular starch staple foods
Keywords
Cognitive Impairment, Diet Interventions, Cognitive Decline, Genetic Risk Factors, Obesity &amp; Overweight
Medical subject headings
Cognitive Dysfunction, Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High resistant starch staple foodsDietary supplement

    Participants in the intervention group will intake high resistant starch staple foods (achieving daily intake of ≥28g resistant starch)

  • Regular starch staple foodsDietary supplement

    Participants in the control group will intake isocaloric regular starch staple foods

Study groups in NCT07152483
Study groupRoleWhat they receive
High-resistant starch foods intervention groupActive comparatorParticipants in the intervention group will intake high resistant starch staple foods (achieving daily intake of ≥28g resistant starch)
Receives: Dietary Supplement: High resistant starch staple foods
Regular starch staple foods control groupPlacebo comparatorParticipants in the control group will intake isocaloric regular starch staple foods
Receives: Dietary Supplement: Regular starch staple foods

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network (NINDS-CSN) protocol (higher scores mean a better outcome)

    Primary Outcome

    Measured: 6 months

Secondary outcomes (16)

  1. Cognitive domain change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network (NINDS-CSN) protocol (higher scores mean a better outcome)

    Secondary Outcome

    Measured: 6 months

  2. Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)

    Secondary Outcome

    Measured: 6 months

  3. Gut microbiota determined by measuring specific bacterial levels in the fecal samples

    Secondary Outcome

    Measured: 6 months

  4. Metabolite composition to measure the metabolite profiles in participants' faecal samples and serum samples

    Secondary Outcome

    Measured: 6 months

  5. Change in waist circumference

    Secondary Outcome

    Measured: 6 months

  6. Change in body mass index (BMI)

    Secondary Outcome

    Measured: 6 months

  7. Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on diffusion tensor imaging (DTI)

    Secondary Outcome

    Measured: 6 months

  8. Changes in image markers (white matter hyperintensity, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI

    Secondary Outcome

    Measured: 6 months

  9. Changes in brain functional network connectivity assessed by resting state functional magnetic resonance imaging (fMRI)

    Secondary Outcome

    Measured: 6 months

  10. Global cognitive function change assessed with Z-score of a digital cognitive assessment protocol (higher scores mean a better outcome)

    Secondary Outcome

    Measured: 6 months

  11. Working memory domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome)

    Secondary Outcome

    Measured: 6 months

  12. Executive function domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome)

    Secondary Outcome

    Measured: 6 months

  13. Language domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome)

    Secondary Outcome

    Measured: 6 months

  14. Visual motor speed domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome)

    Secondary Outcome

    Measured: 6 months

  15. Visual spatial function domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome)

    Secondary Outcome

    Measured: 6 months

  16. Memory and recognition domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome)

    Secondary Outcome

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion1 Apr 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07152483
Sponsor's protocol ID
RICE
Status last verified
Jul 2025
First submitted
26 Aug 2025
Last updated
3 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing High resistant starch staple foods and Regular starch staple foods in people with Cognitive Impairment and Diet Interventions, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 7 inclusion and 14 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: opening soon, as of the sponsor's last update on 3 Sep 2025. 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 Lou, PhD, MD (13958007213, lm99@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network (NINDS-CSN) protocol (higher scores mean a better outcome) (time frame: 6 months). 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 NCT07152483.

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 3 Sep 2025.

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