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

Impact of Low-fat and Full-fat Milk on Lipids and Cardiac Function in Patients With Coronary Artery Disease: A Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: 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 corn-fed cows (fat >3.8%) for 12 weeks; Dietary supplement: 500 mL/day of full-fat milk from grass-fed cows (fat >3.8%) for 12 weeks

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Chinese PLA General Hospital
  • Beijing, China
    • Beijing Chaoyang Hospital Affiliated to Capital Medical University
  • Beijing, China
    • Dongzhimen Hospital
  • Chongqing, China
    • The Third Military Medical University of the Chinese people's Liberation Army
  • Kunming, China
    • The Second Affiliated Hospital of Kunming Medical University
  • Nanjing, China
    • Nanjing First Hospital
  • Shanghai, China
    • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 500 mL/day of low-fat milk (fat <1.5%); All milk is provided by the Inner Mongolia Yili Industrial Group Limited by Share Ltd (Inner Mongolia, China).	Dietary supplement: 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).
Experimental: 500 mL/day of full-fat milk from corn-fed cows (fat >3.8%); All milk is provided by the Inner Mongolia Yili Industrial Group Limited by Share Ltd (Inner Mongolia, China).	Dietary supplement: 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).
Experimental: 500 mL/day of full-fat milk from grass-fed cows (fat >3.8%); All milk is provided by the Inner Mongolia Yili Industrial Group Limited by Share Ltd (Inner Mongolia, China).	Dietary supplement: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 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.	after 12 weeks of intervention

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Investigators: Principal Investigator: Rong Wang, MD, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2020
• Primary Completion (Actual): March 4, 2021
• Study Completion (Actual): March 4, 2021

Study Registration Dates

• First Submitted: August 1, 2024
• First Submitted That Met QC Criteria: August 4, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 4, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: low-fat and full-fat milk

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No