Coronary Artery Disease
Conditions
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.
Interventions
DIETARY_SUPPLEMENT500 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).
DIETARY_SUPPLEMENT500 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).
DIETARY_SUPPLEMENT500 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).
Sponsors
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
(1) Patients with CAD
Exclusion criteria
(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 ≤ 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Ⅰ (apoA Ⅰ), 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. |
Countries
China
Outcome results
None listed