NCT07589036

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

1.2 years

First QC Date

May 5, 2026

Last Update Submit

May 14, 2026

Conditions

Keywords

Dioscorea yam gruelCoronary heart diseasePercutaneous coronary interventionPCIBlood lipidsDietary therapy

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 COMPARATOR

Patients received standard post-procedural treatment and care, including weekly health education lectures (1 hour each) and routine outpatient follow-up every 4 weeks

Other: Standard Post-PCI Care

Dioscorea Yam Gruel Group

EXPERIMENTAL

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

Dietary Supplement: Dioscorea Yam Gruel

Interventions

Standard post-procedural treatment and care including weekly health education lectures (1 hour each) and routine outpatient follow-up every 4 weeks

Standard Care Group
Dioscorea Yam GruelDIETARY_SUPPLEMENT

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

Dioscorea Yam Gruel Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

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

Locations