Coronary Heart Disease (CHD), PCI
Conditions
Keywords
Dioscorea yam gruel, Coronary heart disease, Percutaneous coronary intervention, PCI, Blood lipids, Dietary therapy
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.
Detailed description
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.
Interventions
Standard post-procedural treatment and care including weekly health education lectures (1 hour each) and routine outpatient follow-up every 4 weeks
DIETARY_SUPPLEMENTDioscorea Yam Gruel
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
Sponsors
900th Hospital of PLA Joint Logistic Support Force
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Lipid Profile | 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
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index (BMI) | 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) |
Countries
China
Outcome results
None listed