Coronary Artery DiseaseNCT06542172
Impact of Low-fat and Full-fat Milk on Lipids and Cardiac Function in Patients With Coronary Artery Disease
A study testing 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%) for 12 weeks and 500 mL/day of low-fat milk (fat <1.5%) for 12 weeks in people with Coronary Artery Disease, run by Chinese PLA General Hospital at 7 sites in China.
Trial summary
This trial aimed to investigate the effects of low-fat and full-fat milk on patients with coronary artery disease (CAD). Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- 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%) for 12 weeks and 500 mL/day of low-fat milk (fat <1.5%) for 12 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 7 sitesChina
- Study dates
- 3 Sep 2020to 4 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with CAD
Who cannot join
- 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 locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Beijing Chaoyang Hospital Affiliated to Capital Medical University
Beijing
Chinese PLA General Hospital
Beijing
Dongzhimen Hospital
Beijing
The Third Military Medical University of the Chinese people's Liberation Army
Chongqing
The Second Affiliated Hospital of Kunming Medical University
Kunming
Nanjing First Hospital
Nanjing
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai
About this study
Official title: 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).
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- 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%) for 12 weeks, 500 mL/day of low-fat milk (fat <1.5%) for 12 weeks
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
500 mL/day of full-fat milk from corn-fed cows (fat >3.8%) for 12 weeksDietary 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%) for 12 weeksDietary 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%) for 12 weeksDietary supplement
All milk is provided by the Inner Mongolia Yili Industrial Group Limited by Share Ltd (Inner Mongolia, China).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Dietary Supplement: 500 mL/day of full-fat milk from grass-fed cows (fat >3.8%) for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start3 Sep 2020
- Primary completion4 Mar 2021
- Study completion4 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong Wang, Chinese PLA General Hospital
- Investigators
- Rong Wang, MD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542172
- Sponsor's protocol ID
- low-fat and full-fat milk
- Status last verified
- Aug 2024
- First submitted
- 1 Aug 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Low-fat and Full-fat Milk on Lipids and Cardiac Function in Patients With Coronary Artery Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06542172
- Acronym / sponsor ID
- low-fat and full-fat milk
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 4 Mar 2021 (actual)
- Study completion
- 4 Mar 2021 (actual)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial aimed to investigate the effects of low-fat and full-fat milk on patients with coronary artery disease (CAD).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 500 mL/day of low-fat milk (fat <1.5%) | Experimental | Dietary Supplement: 500 mL/day of low-fat milk (fat <1.5%) for 12 weeksAll 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%) | Experimental | Dietary Supplement: 500 mL/day of full-fat milk from corn-fed cows (fat >3.8%) for 12 weeksAll 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%) | Experimental | Dietary Supplement: 500 mL/day of full-fat milk from grass-fed cows (fat >3.8%) for 12 weeksAll milk is provided by the Inner Mongolia Yili Industrial Group Limited by Share Ltd (Inner Mongolia, China). |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with CAD
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 500 mL/day of full-fat milk from corn-fed cows (fat >3.8%) for 12 weeksAll 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%) |
| 500 mL/day of full-fat milk from grass-fed cows (fat >3.8%) for 12 weeksAll 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%) |
| 500 mL/day of low-fat milk (fat <1.5%) for 12 weeksAll 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%) |
Primary outcome
differences in lipids, sphingolipids, and cardiac function between the three groups after 12 weeks of intervention
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rong Wang, MD principal investigator
Chinese PLA General Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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%) for 12 weeks and 500 mL/day of low-fat milk (fat <1.5%) for 12 weeks in people with Coronary Artery Disease, run by Chinese PLA General Hospital at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
differences in lipids, sphingolipids, and cardiac function between the three groups after 12 weeks of intervention (time frame: after 12 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.