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Completed

NCT Number: NCT07589036

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

900th Hospital of PLA Joint Logistic Support Force

Fuzhou, Fujian, 350025, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Post-PCI Care

Other

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

Dietary 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

Primary outcomes

  1. Blood Lipid Profile

    Time frame: 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

Secondary outcomes

  1. Body Mass Index (BMI)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

900th Hospital of PLA Joint Logistic Support Force

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 15, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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