Coronary Heart Disease (CHD)NCT07589036
Effects of Dioscorea Yam Gruel on Blood Lipid Profiles in PCI Patients With Coronary Heart Disease
A study testing Standard Post-PCI Care and Dioscorea Yam Gruel in people with Coronary Heart Disease (CHD) and PCI, run by 900th Hospital of PLA Joint Logistic Support Force at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Heart Disease (CHD), PCI
- What is being tested?
- Standard Post-PCI Care and Dioscorea Yam Gruel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2024to 15 Mar 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
900th Hospital of PLA Joint Logistic Support Force
Fuzhou, Fujian, 350025
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Heart Disease (CHD), PCI
- Being tested
- Standard Post-PCI Care, Dioscorea Yam Gruel
- Keywords
- Dioscorea yam gruel, Coronary heart disease, Percutaneous coronary intervention, PCI, Blood lipids, Dietary therapy
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Post-PCI CareOther
Standard post-procedural treatment and care including weekly health education lectures (1 hour each) and routine outpatient follow-up every 4 weeks
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Dioscorea Yam Gruel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, Week 8, Week 12
Secondary outcomes (1)
Body Mass Index (BMI)
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)
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start10 Jan 2024
- Primary completion15 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart Disease (CHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- 900th Hospital of PLA Joint Logistic Support Force
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongmei Zhong, 900th Hospital of PLA Joint Logistic Support Force
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589036
- Sponsor's protocol ID
- 2026-05
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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