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

NCT06542172 | Completed

• 1 other identifier: low-fat and full-fat milk
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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).

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

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

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).

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

Interventions

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).

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

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 full-fat milk from grass-fed cows (fat >3.8%)

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).

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

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) Patients with CAD

You may not qualify if:

• (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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (7)

Beijing Chaoyang Hospital Affiliated to Capital Medical University

Beijing, China

Location

Chinese PLA General Hospital

Beijing, China

Location

Dongzhimen Hospital

Beijing, China

Location

The Third Military Medical University of the Chinese people's Liberation Army

Chongqing, China

Location

The Second Affiliated Hospital of Kunming Medical University

Kunming, China

Location

Nanjing First Hospital

Nanjing, China

Location

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

CD36 Antigens; Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Platelet Membrane Glycoproteins; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Fatty Acid Transport Proteins; Membrane Transport Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Receptors, Cell Surface; Receptors, Immunologic; Scavenger Receptors, Class B; Receptors, Scavenger; Receptors, LDL; Receptors, Lipoprotein; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Rong Wang, MD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 7, 2024
• Study Start: September 3, 2020
• Primary Completion: March 4, 2021
• Study Completion: March 4, 2021
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)