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

C

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)

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

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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