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

NCT ID: NCT06542172

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-03

Study Completion Date

2021-03-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

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

Intervention Type 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%)

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

Group Type EXPERIMENTAL

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

Intervention Type 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%)

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

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type 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).

Intervention Type 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).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rong Wang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rong Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Chaoyang Hospital Affiliated to Capital Medical University

Beijing, , China

Site Status

Chinese PLA General Hospital

Beijing, , China

Site Status

Dongzhimen Hospital

Beijing, , China

Site Status

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

Chongqing, , China

Site Status

The Second Affiliated Hospital of Kunming Medical University

Kunming, , China

Site Status

Nanjing First Hospital

Nanjing, , China

Site Status

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

low-fat and full-fat milk

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dairy and Inflammation Study
NCT04902417 COMPLETED NA