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Effects of Dioscorea Yam Gruel on Blood Lipid Profiles in PCI Patients With Coronary Heart Disease

14. maj 2026 opdateret af: Dongmei Zhong, 900th Hospital of PLA Joint Logistic Support Force

Effects of Dioscorea Yam Gruel on Blood Lipid Profiles in PCI Patients With Coronary Heart Disease: A Randomized Controlled Trial

This randomized controlled trial investigated the effects of Dioscorea yam gruel on blood lipid levels in patients with coronary heart disease after percutaneous coronary intervention (PCI). A total of 72 eligible post-PCI patients were randomly assigned to the control group or the intervention group. Patients in the control group received standard post-procedural treatment and care. In addition to this standard regimen, those in the intervention group were provided with approximately 150 g of Dioscorea yam gruel daily as a partial dinner replacement for 12 consecutive weeks. Serum levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and body mass index (BMI) were measured at baseline, and at 8 weeks and 12 weeks of the intervention.

Studieoversigt

Detaljeret beskrivelse

Background:

Percutaneous coronary intervention (PCI) is an important revascularization strategy for coronary heart disease, but it cannot reverse the fundamental pathological process of atherosclerosis. Dyslipidemia is a core risk factor for disease progression. This study aimed to investigate the effects of Dioscorea yam gruel, a traditional Chinese dietary therapy, on blood lipid levels in patients after PCI.

Methods (Brief Outline):

Seventy-two post-PCI patients were randomized 1:1 to control (standard care) or intervention (standard care plus 150 g/day Dioscorea yam gruel for 12 weeks). Lipid profiles were assessed at baseline, 8 weeks, and 12 weeks. Body mass index (BMI) was measured at baseline and 12 weeks.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

72

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

    • Fujian
      • Fuzhou, Fujian, Kina, 350025
        • 900th Hospital of PLA Joint Logistic Support Force

Deltagelseskriterier

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Berettigelseskriterier

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  • Voksen
  • Ældre voksen

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Ingen

Beskrivelse

Inclusion Criteria:

  • Meeting the diagnostic criteria for coronary heart disease (2020 edition)
  • Undergoing percutaneous coronary intervention (PCI)
  • Aged between 18 and 75 years
  • Having been on a stable dose of statin therapy for at least 4 weeks prior to screening
  • Being in a stable clinical condition, conscious, providing informed consent, and participating voluntarily

Exclusion Criteria:

  • Low-density lipoprotein cholesterol (LDL-C) level < 70 mg/dL(<1.81mmol/L) at screening
  • Complicating with other severe diseases or diseases that affect blood lipid levels, such as malignant tumors, acute cerebrovascular disease, nephrotic syndrome, severe liver disease, Cushing's syndrome, and others
  • Pregnancy or lactation
  • Concurrently participating in other dietary or exercise intervention programs

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Standard Care Group
Patients received standard post-procedural treatment and care, including weekly health education lectures (1 hour each) and routine outpatient follow-up every 4 weeks
Standard post-procedural treatment and care including weekly health education lectures (1 hour each) and routine outpatient follow-up every 4 weeks
Eksperimentel: Dioscorea Yam Gruel Group
In addition to all interventions received by the control group, patients consumed approximately 150 g of Dioscorea yam gruel daily as a partial dinner replacement for 12 consecutive weeks
In addition to receiving all standard post-PCI care (weekly health education lectures and routine 4-week follow-up), patients consumed approximately 150 g of Dioscorea yam gruel daily as a partial dinner replacement for 12 consecutive weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Blood Lipid Profile
Tidsramme: Baseline, Week 8, Week 12
Serum levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), and high-density lipoprotein cholesterol (HDL-C) were measured at baseline, 8 weeks, and 12 weeks of the intervention
Baseline, Week 8, Week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body Mass Index (BMI)
Tidsramme: Baseline, Week 12
Body mass index was measured at baseline and at 12 weeks post-intervention. Height and weight were measured using a standard stadiometer and scale. BMI was calculated as weight in kilograms divided by the square of height in meters (kg/m^2)
Baseline, Week 12

Samarbejdspartnere og efterforskere

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Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. januar 2024

Primær færdiggørelse (Faktiske)

15. marts 2025

Studieafslutning (Faktiske)

15. marts 2025

Datoer for studieregistrering

Først indsendt

5. maj 2026

Først indsendt, der opfyldte QC-kriterier

9. maj 2026

Først opslået (Faktiske)

15. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared because the study data contain potentially identifiable patient information, and the informed consent obtained from participants did not explicitly include provisions for public data sharing. Additionally, institutional policy currently does not require or support the open sharing of individual-level clinical trial data

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