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Effect of time-restricted feeding on cognitive dysfunction in Alzheimer's disease and the mediating mechanism of ApoE polymorphism: a randomised controlled trial

Effect of time-restricted feeding on cognitive dysfunction in Alzheimer's disease and the mediating mechanism of ApoE polymorphism: a randomised controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092653
Enrollment
Unknown
Registered
2024-11-21
Start date
2024-11-25
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Interventions

ApoE4-/- +TRF:Time restricted feeding
ApoE4-/- +NC:None
ApoE4+/-/ ApoE4+/+ +NC:None
ApoE4+/-/ ApoE4+/+ +TRF:Time restricted feeding
Normal control group:None

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 100 Years

Inclusion criteria

Inclusion criteria: AD patients: (1)Consistent with the NIA-AA determination of Alzheimer's disease-induced mild/moderate cognitive impairment;(2)Age >=50 years old, Male or Female;(3)Patients were informed and consented to participate in this study and agreed to attend all visits, examinations, and treatments as required by the study protocol. Control group: (1) No history of memory decline or other related cognitive impairment; (2) normal daily living ability; (3) MMSE scores: illiteracy >21, primary school culture >24, secondary school culture >27; (4) No imaging contraindications.

Exclusion criteria

Exclusion criteria: (1)Severe AD and cognitive impairment due to surgery or other reasons; (2)A history of inflammatory bowel disease, carbohydrate malabsorption, hormonal imbalance, known allergy to food additives, or any other serious medical condition; (3)History of gallbladder removal, gastrointestinal and cranial brain surgeries; (4)Parasitic infections; (5)Unable to cooperate with the study due to suicidal thoughts, attempts or aggressive behavior; (6)Use of medications known to affect gastrointestinal function, blood pressure and lipids, hormone supplements, allergy/asthma medications, proton pump inhibitors and over-the-counter medications; (7)use of probiotics or antibiotics or prebiotics (dietary fiber, oligosaccharides) within the 8 weeks prior to the trial; alcohol or drug abuse; (8)Patients with a history of major trauma; (9)Patients with moderate and severe malnutrition; (10)Patients with type 1 diabetes, Latent autoimmune diabetes in adults (LADA) and type 2 diabetes with fasting blood glucose greater than 10.11mmol/L; (11)Use of drugs with known ketogenic tendencies (such as SGLT2, etc.) (12)Patients who have received an organ transplant or have previously received a non-autologous (allogeneic) bone marrow or stem cell transplant; (13)Patients who have contraindications for cranial brain imaging such as post-steel plate placement, claustrophobia, etc.; or inability to cooperate with perfect imaging examination because of agitation, etc.

Design outcomes

Primary

MeasureTime frame
Scale score of Minimum Mental State Examination (MMSE);Scale score of Montreal Cognitive Assessment (MoCA);Scale score of Clinical Dementia Rating-Sum of Boxes (CDR-SB);

Secondary

MeasureTime frame
Scale score of Activity of DailyLiving Scale (ADL);Peripheral blood AD biomarkers;blood lipid levels;Serum ketone body levels;Plasma metabolome levels;Gut microbiota;Brain glutamate levels;

Countries

China

Contacts

Public ContactJun Hu

Peking University Shenzhen Hospital

dochj@163.com+86 138 2875 6497

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026