Impact of Low-fat and Full-fat Milk on Lipids and Cardiac Function in Patients With Coronary Artery Disease

Chinese PLA General Hospital (301 Hospital)

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Dietary Supplement: 500 mL/day of low-fat milk (fat <1.5%) for 12 weeks; Dietary Supplement: 500 mL/day of full-fat milk from grass-fed cows (fat >3.8%) for 12 weeks; Dietary Supplement: 500 mL/day of full-fat milk from corn-fed cows (fat >3.8%) for 12 weeks

Study type: Interventional

Funder types: Other

Identifiers

NCT06542172

low-fat and full-fat milk

Details and patient eligibility

About

This trial aimed to investigate the effects of low-fat and full-fat milk on patients with coronary artery disease (CAD).

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

500 mL/day of low-fat milk (fat <1.5%)

Experimental group

Description:

All milk is provided by the Inner Mongolia Yili Industrial Group Limited by Share Ltd (Inner Mongolia, China).

Treatment:

Dietary Supplement: 500 mL/day of low-fat milk (fat <1.5%) for 12 weeks

500 mL/day of full-fat milk from corn-fed cows (fat >3.8%)

Experimental group

Description:

All milk is provided by the Inner Mongolia Yili Industrial Group Limited by Share Ltd (Inner Mongolia, China).

Treatment:

Dietary Supplement: 500 mL/day of full-fat milk from corn-fed cows (fat >3.8%) for 12 weeks

500 mL/day of full-fat milk from grass-fed cows (fat >3.8%)

Experimental group

Description:

All milk is provided by the Inner Mongolia Yili Industrial Group Limited by Share Ltd (Inner Mongolia, China).

Treatment:

Dietary Supplement: 500 mL/day of full-fat milk from grass-fed cows (fat >3.8%) for 12 weeks