Cardiovascular DiseasesNCT05423457
Diets, Lipoproteins and Inflammation Markers
A study testing Vegan diet in people with Cardiovascular Diseases and Metabolic Syndrome, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
Systematic inflammation and lipid profiles are two major therapeutic targets for cardiovascular diseases. The effectiveness of vegan diet has been reported (doi: 10.3389/fnut.2022.807810). Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Cardiovascular Diseases, Metabolic Syndrome, Diet, Healthy
- What is being tested?
- Vegan diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Jul 2017to 15 Jun 2018
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with dyslipidemia (at least one of the following)
- TG ≥ 150 mg/dL
- TC ≥ 200 mg/dL
- LDL-c≥ 130 mg/dL,
- HDL-c < 45 mg/dL for male or < 55 mg/dL for female or receiving statin treatment
- Exclusion Criteria (fulfill one of the following condition):
Show all 12Show fewer
- chronic kidney disease
- history of coronary artery disease
- ischemic heart disease,
- heart failure,
- stroke,
- cancer of any type
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Vegan Diet and MyPlate Diet (Taiwanese Version) on Lipoproteins, Novel Markers of Cardiovascular Diseases, and Traditional Cardiometabolic Risk Factors
Systematic inflammation and lipid profiles are two major therapeutic targets for cardiovascular diseases. The effectiveness of vegan diet has been reported (doi: 10.3389/fnut.2022.807810).
Aim:
To compare the effectiveness of a nutritionally balanced vegan diet and a Myplate diet ((Taiwanese version) on systematic inflammation and lipoprotein subclass.
Design: Randomized crossover design
- Conditions
- Cardiovascular Diseases, Metabolic Syndrome, Diet, Healthy, Vegan Diet, Inflammatory Response
- Being tested
- Vegan diet
- Medical subject headings
- Cardiovascular Diseases, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vegan dietBehavioural
The participants were advised to eat foods in their original type.
| Study group | Role | What they receive |
|---|---|---|
| Vegan diet | Experimental | Participants were provided with and instructed to eat these foods:
* flaxseed meal,
* walnuts,
* pecans,
* extra-virgin olive oil,
* Brazil nuts
* Taiwanese purple laver (also known as "hong-mao-tai" or Bangia atropurpurea, and was selected to test for its vitamin B12 bioavailability).
Each Participant has three group sessions and three individual nutrition counseling with a dietitian. Receives: Behavioral: Vegan diet |
| MyPlate (Taiwanese version) | Active comparator | Each Participant has three group sessions and three individual nutrition counseling with a dietitian. Receives: Behavioral: Vegan diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Novel inflammatory markers for cardiovascular disease and Lipoprotein particles concentration
GlycA (umol/L), lipoprotein particles concentration(umol/L)
Measured: 12 weeks
Lipoprotein particles concentration
lipoprotein particles concentration (nmol/L）
Measured: 12 weeks
lipoprotein particles size
lipoprotein particles size (nm)
Measured: 12 weeks
Trimethylamine-N-oxide
TMAO (uM). TMAO is a low molecular weight compound that belongs to the class of amine oxides
Measured: 12 weeks
Traditional cadiometabolic risk factors 1
TG(mg/dL), LDL-C(mg/dL), HDL-C(mg/dL), Total cholesterol(mg/dL)
Measured: 12 weeks
Traditional cadiometabolic risk factors 2
HbA1c(%)
Measured: 12 weeks
Traditional cadiometabolic risk factors 3
HOMA-IR index (Homeostasis Model Assessment-Insulin Resistance index)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start18 Jul 2017
- Primary completion14 Jun 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423457
- Sponsor's protocol ID
- IRB106-92-B
- Status last verified
- Jun 2019
- First submitted
- 30 May 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- 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 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Vegan Diet and MyPlate Diet (Taiwanese Version) on Lipoproteins, Novel Markers of Cardiovascular Diseases, and Traditional Cardiometabolic Risk Factors
- ClinicalTrials.gov ID
- NCT05423457
- Acronym / sponsor ID
- IRB106-92-B
- Conditions
- Cardiovascular Diseases, Metabolic Syndrome, Diet, Healthy, Vegan Diet, Inflammatory Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 14 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 21 Jun 2022 (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.
Systematic inflammation and lipid profiles are two major therapeutic targets for cardiovascular diseases. The effectiveness of vegan diet has been reported (doi: 10.3389/fnut.2022.807810).
Aim:
To compare the effectiveness of a nutritionally balanced vegan diet and a Myplate diet ((Taiwanese version) on systematic inflammation and lipoprotein subclass.
Design: Randomized crossover design
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vegan diet | Experimental | Behavioral: Vegan dietParticipants were provided with and instructed to eat these foods: * flaxseed meal, * walnuts, * pecans, * extra-virgin olive oil, * Brazil nuts * Taiwanese purple laver (also known as "hong-mao-tai" or Bangia atropurpurea, and was selected to test for its vitamin B12 bioavailability). Each Participant has three group sessions and three individual nutrition counseling with a dietitian. |
| MyPlate (Taiwanese version) | Active comparator | Behavioral: Vegan dietEach Participant has three group sessions and three individual nutrition counseling with a dietitian. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with dyslipidemia (at least one of the following)
- TG ≥ 150 mg/dL
- TC ≥ 200 mg/dL
- LDL-c≥ 130 mg/dL,
- HDL-c < 45 mg/dL for male or < 55 mg/dL for female or receiving statin treatment
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Vegan dietThe participants were advised to eat foods in their original type. | Behavioural | MyPlate (Taiwanese version), Vegan diet |
Primary outcome
Novel inflammatory markers for cardiovascular disease and Lipoprotein particles concentration
Time frame: 12 weeks
GlycA (umol/L), lipoprotein particles concentration(umol/L)
Lipoprotein particles concentration
Time frame: 12 weeks
lipoprotein particles concentration (nmol/L）
lipoprotein particles size
Time frame: 12 weeks
lipoprotein particles size (nm)
Trimethylamine-N-oxide
Time frame: 12 weeks
TMAO (uM). TMAO is a low molecular weight compound that belongs to the class of amine oxides
Traditional cadiometabolic risk factors 1
Time frame: 12 weeks
TG(mg/dL), LDL-C(mg/dL), HDL-C(mg/dL), Total cholesterol(mg/dL)
Traditional cadiometabolic risk factors 2
Time frame: 12 weeks
HbA1c(%)
Traditional cadiometabolic risk factors 3
Time frame: 12 weeks
HOMA-IR index (Homeostasis Model Assessment-Insulin Resistance index)
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 21 Feb 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vegan diet in people with Cardiovascular Diseases and Metabolic Syndrome, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
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 12 inclusion and 0 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 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
Novel inflammatory markers for cardiovascular disease and Lipoprotein particles concentration (time frame: 12 weeks). The study lists 7 primary outcomes in all. 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 21 Feb 2023.