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This trial aimed to investigate the effects of low-fat and full-fat milk on patients with coronary artery disease (CAD).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 500 mL/day of low-fat milk (fat <1.5%) | Experimental | 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%) | Experimental | 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%) | Experimental | All milk is provided by the Inner Mongolia Yili Industrial Group Limited by Share Ltd (Inner Mongolia, China). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 500 mL/day of full-fat milk from corn-fed cows (fat >3.8%) for 12 weeks | Dietary Supplement | All milk is provided by the Inner Mongolia Yili Industrial Group Limited by Share Ltd (Inner Mongolia, China). |
| Measure | Description | Time Frame |
|---|---|---|
| differences in lipids, sphingolipids, and cardiac function between the three groups 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 â… (apoA â… ), 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. | after 12 weeks of intervention |
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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.](streamdown:incomplete-link)
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| Name | Affiliation | Role |
|---|---|---|
| Rong Wang, MD | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chaoyang Hospital Affiliated to Capital Medical University | Beijing | China | ||||
| Chinese PLA General Hospital |
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| 500 mL/day of full-fat milk from grass-fed cows (fat >3.8%) for 12 weeks | Dietary Supplement | All milk is provided by the Inner Mongolia Yili Industrial Group Limited by Share Ltd (Inner Mongolia, China). |
|
| 500 mL/day of low-fat milk (fat <1.5%) for 12 weeks | Dietary Supplement | All milk is provided by the Inner Mongolia Yili Industrial Group Limited by Share Ltd (Inner Mongolia, China). |
|
| Beijing |
| China |
| Dongzhimen Hospital | Beijing | China |
| The Third Military Medical University of the Chinese people's Liberation Army | Chongqing | China |
| The Second Affiliated Hospital of Kunming Medical University | Kunming | China |
| Nanjing First Hospital | Nanjing | China |
| Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | China |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D018955 | CD36 Antigens |
| D018752 | Diet, Fat-Restricted |
| ID | Term |
|---|---|
| D010980 | Platelet Membrane Glycoproteins |
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D050612 | Fatty Acid Transport Proteins |
| D026901 | Membrane Transport Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008565 | Membrane Proteins |
| D011956 | Receptors, Cell Surface |
| D011971 | Receptors, Immunologic |
| D051122 | Scavenger Receptors, Class B |
| D051116 | Receptors, Scavenger |
| D011973 | Receptors, LDL |
| D018110 | Receptors, Lipoprotein |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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