Impact of Low-fat and Full-fat Milk on Lipids and Cardiac Function in Patients With Coronary Artery Disease
- Conditions
- Coronary Artery Disease
- Interventions
- Dietary Supplement: 500 mL/day of low-fat milk (fat <1.5%) for 12 weeksDietary Supplement: 500 mL/day of full-fat milk from corn-fed cows (fat >3.8%) for 12 weeksDietary Supplement: 500 mL/day of full-fat milk from grass-fed cows (fat >3.8%) for 12 weeks
- Registration Number
- NCT06542172
- Lead Sponsor
- Chinese PLA General Hospital
- Brief Summary
This trial aimed to investigate the effects of low-fat and full-fat milk on patients with coronary artery disease (CAD).
- Detailed Description
The effects of low-fat and full-fat milk on lipid profiles and sphingolipid profiles in CAD patients are not well understood. In addition, milk intake is at a low level in the Chinese population compared with developed countries. Therefore, we aimed to conduct a randomized controlled trial to investigate the effects of low-fat and full-fat milk on lipid profiles, sphingolipid profiles, and cardiac performance in Chinese CAD patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
(1) Patients with CAD
(1) patients <18 years of age; (2) patients with systemic active infection; (3) patients with severe hepatic and renal dysfunction [alanine aminotransferase (ALT) > 135mmol/L, creatinine > 200umol/L), or chronic lung disease; (4) patients with a life expectancy β€ 6 months due to bleeding tendency and hematological diseases, malignant tumors, and end-stage diseases; (5) patients with valvular heart disease or left ventricular aneurysm who needed simultaneous surgeries; (6) patients with cerebrovascular disease (cerebral infarction or cerebral hemorrhage within 6 months before enrollment); (7) patients who enrolled in other drug intervention trials; (8) patients who received emergency percutaneous coronary intervention (PCI); and (9) patients who reported intolerance to lactose.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 500 mL/day of low-fat milk (fat <1.5%) 500 mL/day of low-fat milk (fat <1.5%) for 12 weeks All milk is provided by the Inner Mongolia Yili Industrial Group Limited by Share Ltd (Inner Mongolia, China). 500 mL/day of full-fat milk from corn-fed cows (fat >3.8%) 500 mL/day of full-fat milk from corn-fed cows (fat >3.8%) for 12 weeks All milk is provided by the Inner Mongolia Yili Industrial Group Limited by Share Ltd (Inner Mongolia, China). 500 mL/day of full-fat milk from grass-fed cows (fat >3.8%) 500 mL/day of full-fat milk from grass-fed cows (fat >3.8%) for 12 weeks All milk is provided by the Inner Mongolia Yili Industrial Group Limited by Share Ltd (Inner Mongolia, China).
- Primary Outcome Measures
Name Time Method differences in lipids, sphingolipids, and cardiac function between the three groups after 12 weeks of intervention after 12 weeks of intervention The lipids contain total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), small dense LDL (sd LDL), large buoyant LDL (lb LDL), phospholipids, apolipoprotein A β (apoA β ), apolipoprotein B (apoB), and lipoprotein (a). Sphingomyelins (C16:0, C20:0, C20.1:0, C22:0, C24.1:0) as well as their metabolites such as ceramides (C16:0, C18:0, C18.1:0, C20:0, C20.1:0, C22:0, C24:0, C24.1:0), sphingosine, and sphingosine 1-phosphate, were also measured.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Beijing Chaoyang Hospital Affiliated to Capital Medical University
π¨π³Beijing, China
Chinese PLA General Hospital
π¨π³Beijing, China
The Third Military Medical University of the Chinese people's Liberation Army
π¨π³Chongqing, China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
π¨π³Shanghai, China
The Second Affiliated Hospital of Kunming Medical University
π¨π³Kunming, China
Nanjing First Hospital
π¨π³Nanjing, China
Dongzhimen Hospital
π¨π³Beijing, China