Effects of Dioscorea Yam Gruel on Blood Lipid Profiles in PCI Patients With Coronary Heart Disease
1 other identifier
interventional
72
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2025
CompletedFirst Submitted
Initial submission to the registry
May 5, 2026
CompletedFirst Posted
Study publicly available on registry
May 15, 2026
CompletedMay 18, 2026
May 1, 2026
1.2 years
May 5, 2026
May 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood Lipid Profile
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
Secondary Outcomes (1)
Body Mass Index (BMI)
Baseline, Week 12
Study Arms (2)
Standard Care Group
ACTIVE COMPARATORPatients received standard post-procedural treatment and care, including weekly health education lectures (1 hour each) and routine outpatient follow-up every 4 weeks
Dioscorea Yam Gruel Group
EXPERIMENTALIn 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
Interventions
Standard post-procedural treatment and care including weekly health education lectures (1 hour each) and routine outpatient follow-up every 4 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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
900th Hospital of PLA Joint Logistic Support Force
Fuzhou, Fujian, 350025, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Participants and care providers were not blinded due to the nature of the dietary intervention. Outcome assessors and data analysts were blinded to group allocation throughout the trial
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nurse-in-charge
Study Record Dates
First Submitted
May 5, 2026
First Posted
May 15, 2026
Study Start
January 10, 2024
Primary Completion
March 15, 2025
Study Completion
March 15, 2025
Last Updated
May 18, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
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