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The regulatory effect of precise nutritional intervention based on lipid metabolism balance on early carotid atherosclerotic plaques/sclerosis

The regulatory effect of precise nutritional intervention based on lipid metabolism balance on early carotid atherosclerotic plaques/sclerosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113737
Enrollment
Unknown
Registered
2025-12-02
Start date
2025-12-02
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Atherosclerosis

Interventions

Experimental Group (Part Two: Intervention Research):Under the premise of not affecting normal clinical diagnosis and treatment, in addition to providing nutritional dietary guidance to the subjects b
Control Group (Part Two: Intervention Study):Under the premise of not affecting normal clinical diagnosis and treatment, only dietary guidance will be provided, and no intervention drugs will be suppl
Observation Group of Carotid Intima-media Thickening (Part One: Cross-sectional Study):None

Sponsors

Department of Nutrition, the First Medical Center, Chinese PLA General Hospita
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (Phase One) Cross-sectional study Inclusion criteria: 1.Age: 18 to 70 years old 2.IMT>=1.0mm + degree of stenosis >=20% 3. At least one metabolic risk (hyperlipidemia, obesity, hypertension (Phase Two) Randomized controlled trial Inclusion criteria (strictly limited early plaques) : For patients with atherosclerosis, the thickness of plaques in the head and neck arteries (including subclavicular area) is 1.5mm=90cm/ female >=85cm) (2) Imbalance in fatty acid profiles (AA:EPA, ?-3: ?-6 imbalance) (3) HDL-C=1.7mmol/L

Exclusion criteria

Exclusion criteria: (Phase One) Cross-sectional study 1. Recent cardiovascular events (within 3 months) 2. End-stage renal disease and active cancer 3. High-intensity lipid-lowering therapy (statins +PCSK9 inhibitors) (Phase Two) Randomized controlled trial 1. There is a significant increase in blood lipid levels (TC > 6.99mmol/L or LDL-C > 4.92mmol/L) 2. Patients with acute coronary syndrome or those who have undergone surgery and are currently taking statins or PCSK9 inhibitors (elumab) 3. Patients with a history of acute stroke or TIA 4. Those with concurrent heart valve lesions, atrial fibrillation and other arrhythmias or heart failure Patients with symptoms and carotid artery stenosis greater than 70% who meet the indications for surgical treatment and interventional therapy 6. Patients with severe liver, kidney, brain and blood system diseases, and malignant tumors 7. People infected with HIV, HCV or HBV 8. Pregnant and lactating women; 9. Those that the researchers consider should not be included

Design outcomes

Primary

MeasureTime frame
Intima-media thickness of carotid artery plaques;Fatty acid profile;The length of carotid artery plaque;Inflammatory factors(IL-1,IL-2,IL-6,IL-8,IL-10,CRP);Lipid metabolism indicators(Low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, total cholesterol,Apolipoprotein A, apolipoprotein B);Metabolomics indicators;Vitamins (A, B1, B2, B6, B9, B12, C, D, E);The degree of carotid artery stenosis;

Secondary

MeasureTime frame
Oxidative stress indicators(MDA,SOD);Blood routine;Immune indicators (lgA, lgG);

Countries

China

Contacts

Public ContactLiu Yinghua

Department of Nutrition, the First Medical Center, Chinese PLA General Hospital

liuyinghua77@163.com+86 66937443

Outcome results

None listed

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