Cardiovascular RiskNCT05882266
The Role of Plant-Based Omega-3 Fatty Acids and Molecular Characterisation in Individuals With Cardiovascular(CVD) Risk
A study testing Plant Omega and Dietary therapy only in people with Cardiovascular Risk, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial summary
The goal of this clinical trial is to investigate the outcome of plant-based omega-3 intervention on lipid profile and blood pressure after 12 weeks and to study the molecular markers associated with the incidence of CVD risk. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cardiovascular Risk
- What is being tested?
- Plant Omega and Dietary therapy only
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteMalaysia
- Study dates
- 20 Dec 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Malaysian aged 18 to 60 years
- BMI between 18.5 and 39.9 kg/m2
- Not on any weight loss therapy
- Is able to commit to 12 weeks of either intervention
- Presented signs of metabolic syndrome or moderate hypercholesterolemia
Who cannot join
- Those who are pregnant or lactating
- Had undergone bariatric surgery
- Who have acute illnesses such as flu
- Who has any diabetes-related chronic complications except hypertension and hyperlipidemia
- Having chronic diseases in particular cancer, liver, kidney, heart disease, stroke, or psychiatric illness
- Having eating disorder or hypothyroidism
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
Beacon Hospital Sdn Bhd
Petaling Jaya, Selangor, 46050
Sook Hui Tay, +60163040540, rebecca.tay@beaconhospital.com.my
Geeta Appanah, PhD
About this study
Official title: The Role of Plant-Based Omega-3 Fatty Acids and Molecular Characterisation in Individuals With Cardiovascular(CVD) Risk at Beacon Hospital in Selangor
The goal of this clinical trial is to investigate the outcome of plant-based omega-3 intervention on lipid profile and blood pressure after 12 weeks and to study the molecular markers associated with the incidence of CVD risk. The main questions it aims to answer are:
- What is the role of plant-based omega-3 intervention on lipid profile and blood pressure of individuals with CVD risk after 12 weeks?
- What is the association between unique molecular markers and plant-based omega-3 intervention among individuals with CVD risk?
Read more
Participants will be subjected to two groups:
- Treatment group: Receive standard dietary therapy and plant-based omega-3 supplemental beverage consumed once daily during breakfast
- Control group: Receive only standard dietary therapy
Researcher will compare between treatment and control group to see the effect of plant based omega-3 on lipid profile and blood pressure after 12 weeks
Read the detailed description
This study is a single-blinded, randomised controlled, parallel clinical trial with the aim to compare the effect of plant-based omega-3 versus standard dietary therapy among individuals with CVD risk for 12 weeks. The randomisation will be done by an independent researcher.
Following, the sample size for this study is 72 individuals with CVD risk, calculated based from two previous studies that investigated the effect of plant based omega 3 intake on cardiometabolic risk individuals and dairy beverages intake among type 2 diabetes mellitus patient.
Besides that, demographic information, medical history, medication history, social history, family history and nutritional information will be gathered using the Case Report Form (CRF) along with 3 days diet record and International Physical Activity Questionnaire (IPAQ) for physical activities assessment. Furthermore, anthropometric data, pain assessment, product sensory evaluation and compliance assessment will also be assessed using the same CRF form.
Correspondingly, 10-hour fasting blood sample (20ml) will be collected from a total of 72 subjects (treatment group, n=36 and control group, n= 36, respectively) for the blood test profiles and genotyping microarray analysis. Subjects need to avoid any alcohol intake, unusual amounts of physical activity and unusual amounts of food intake within 24-hour of blood taking. All the biochemical analyses will be done and entirely sponsored by Beacon Precision Diagnostics Sdn. Bhd. The study will be conducted in compliance with ethical principles outlined in the Declaration of Helsinki and Malaysian Good Clinical Practice Guideline.
Also, subjects shall be informed of the study during their usual clinic visits. They will be requested to contact investigators if they are interested. An appointment will be made where the subject information sheet will be provided and explained to them. If they are willing to participate, the consent forms will be signed and dated. If they need to, they are allowed to take the information sheet home to consult with their family members and another day for getting consent arranged. This study is an independent study, subjects can choose to withdraw at any time. Lastly, the investigators declare they have no conflict of interest.
- Conditions
- Cardiovascular Risk
- Being tested
- Plant Omega, Dietary therapy only
- Keywords
- cvd risk, cardiovascular risk, plant omega, plant based omega 3, omega 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant OmegaDietary supplement
A commercial plant-based omega-3 beverage consumed once daily during breakfast
Dietary therapy onlyOther
Standard dietary therapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Receive standard dietary therapy and plant-based omega-3 supplemental beverage consumed once daily during breakfast. Receives: Dietary Supplement: Plant Omega |
| Control | Placebo comparator | Receive only standard dietary therapy Receives: Other: Dietary therapy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in lipid profile after 12 weeks intervention of plant based omega 3
Changes in the lipid profile level of LDL, HDL, total cholesterol, triglyceride using standard metric (mmol/L)
Measured: Baseline and Week 12
Changes in the blood pressure after 12 weeks intervention of plant based omega 3
Changes in both systolic and diastolic blood pressure using the standard unit (mmHg)
Measured: Baseline and Week 12
Changes in microarray gene expression profile in blood from individual with CVD risk
Changes in microarray gene expression profile in blood from individual with CVD risk, in response to the 12 weeks intake of plant based omega 3
Measured: Baseline and Week 12
Secondary outcomes (4)
Changes in anti-inflammatory effect of plant-based omega-3 after 12 weeks
Changes in high-sensitivity C-Reactive Protein (hs-CRP) using standard metric (mg/L)
Measured: Baseline, Week 12
Changes in fasting blood glucose after 12 weeks intervention of plant based omega-3
Changes in fasting blood glucose using standard metric (mmol/L)
Measured: Baseline, Week 12
Changes in glycated hemoglobin after 12 weeks intervention of plant based omega-3
Changes in glycated hemoglobin (hbA1c) using standard metric (%)
Measured: Baseline, Week 12
Changes in quality of life of individuals with CVD risk, before and after the consumption of plant-based omega 3 for 12 weeks
Changes in pain score assess using the short 0-10 numeric pain scale. It is a validated self-reported instrument assessing average pain intensity over the past 24 hour period. Possible scores range from 0 (no pain) to 10 (worst possible pain).
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start20 Dec 2024 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular RiskStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a non-weight loss interventional study. This study employed a single-blinded, randomised controlled, parallel design to compare the effect of plant-based omega-3 versus standard dietary therapy among individuals with CVD risk for 12 weeks. The randomisation will be done by an independent researcher. The intervention study had comprised two groups: * Treatment group: Receive standard dietary therapy and plant-based omega-3 supplemental beverage consumed once daily during breakfast. * Control group: Receive only standard dietary therapy
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Beacon Hospital Sdn Bhd
- Responsible party
- Principal investigator, Gew Soon Peng, Universiti Putra Malaysia
- Investigators
- Yoke Kqueen Cheah, Principal investigator, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882266
- Sponsor's protocol ID
- RSCH ID-23-00839-PGP
- Status last verified
- Dec 2024
- First submitted
- 24 Apr 2023
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schmidt KA, Cromer G, Burhans MS, Kuzma JN, Hagman DK, Fernando I, Murray M, Utzschneider KM, Holte S, Kraft J, Kratz M. The impact of diets rich in low-fat or full-fat dairy on glucose tolerance and its determinants: a randomized controlled trial. Am J Clin Nutr. 2021 Mar 11;113(3):534-547. doi: 10.1093/ajcn/nqaa301.
PubMed 33184632Tovar J, Nilsson A, Johansson M, Bjorck I. Combining functional features of whole-grain barley and legumes for dietary reduction of cardiometabolic risk: a randomised cross-over intervention in mature women. Br J Nutr. 2014 Feb;111(4):706-14. doi: 10.1017/S000711451300305X. Epub 2013 Sep 24.
PubMed 24063257
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Plant-Based Omega-3 Fatty Acids and Molecular Characterisation in Individuals With Cardiovascular(CVD) Risk at Beacon Hospital in Selangor
- ClinicalTrials.gov ID
- NCT05882266
- Acronym / sponsor ID
- RSCH ID-23-00839-PGP
- Conditions
- Cardiovascular Risk
- Keywords
- cvd risk, cardiovascular risk, plant omega, plant based omega 3, omega 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- Beacon Hospital Sdn Bhd
- Study start
- 20 Dec 2024 (estimated)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 31 May 2023 (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.
The goal of this clinical trial is to investigate the outcome of plant-based omega-3 intervention on lipid profile and blood pressure after 12 weeks and to study the molecular markers associated with the incidence of CVD risk. The main questions it aims to answer are:
- What is the role of plant-based omega-3 intervention on lipid profile and blood pressure of individuals with CVD risk after 12 weeks?
- What is the association between unique molecular markers and plant-based omega-3 intervention among individuals with CVD risk?
Participants will be subjected to two groups:
- Treatment group: Receive standard dietary therapy and plant-based omega-3 supplemental beverage consumed once daily during breakfast
- Control group: Receive only standard dietary therapy
Researcher will compare between treatment and control group to see the effect of plant based omega-3 on lipid profile and blood pressure after 12 weeks
Detailed description
This study is a single-blinded, randomised controlled, parallel clinical trial with the aim to compare the effect of plant-based omega-3 versus standard dietary therapy among individuals with CVD risk for 12 weeks. The randomisation will be done by an independent researcher.
Following, the sample size for this study is 72 individuals with CVD risk, calculated based from two previous studies that investigated the effect of plant based omega 3 intake on cardiometabolic risk individuals and dairy beverages intake among type 2 diabetes mellitus patient.
Besides that, demographic information, medical history, medication history, social history, family history and nutritional information will be gathered using the Case Report Form (CRF) along with 3 days diet record and International Physical Activity Questionnaire (IPAQ) for physical activities assessment. Furthermore, anthropometric data, pain assessment, product sensory evaluation and compliance assessment will also be assessed using the same CRF form.
Correspondingly, 10-hour fasting blood sample (20ml) will be collected from a total of 72 subjects (treatment group, n=36 and control group, n= 36, respectively) for the blood test profiles and genotyping microarray analysis. Subjects need to avoid any alcohol intake, unusual amounts of physical activity and unusual amounts of food intake within 24-hour of blood taking. All the biochemical analyses will be done and entirely sponsored by Beacon Precision Diagnostics Sdn. Bhd. The study will be conducted in compliance with ethical principles outlined in the Declaration of Helsinki and Malaysian Good Clinical Practice Guideline.
Also, subjects shall be informed of the study during their usual clinic visits. They will be requested to contact investigators if they are interested. An appointment will be made where the subject information sheet will be provided and explained to them. If they are willing to participate, the consent forms will be signed and dated. If they need to, they are allowed to take the information sheet home to consult with their family members and another day for getting consent arranged. This study is an independent study, subjects can choose to withdraw at any time. Lastly, the investigators declare they have no conflict of interest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a non-weight loss interventional study. This study employed a single-blinded, randomised controlled, parallel design to compare the effect of plant-based omega-3 versus standard dietary therapy among individuals with CVD risk for 12 weeks. The randomisation will be done by an independent researcher. The intervention study had comprised two groups: * Treatment group: Receive standard dietary therapy and plant-based omega-3 supplemental beverage consumed once daily during breakfast. * Control group: Receive only standard dietary therapy
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: Plant OmegaReceive standard dietary therapy and plant-based omega-3 supplemental beverage consumed once daily during breakfast. |
| Control | Placebo comparator | Other: Dietary therapy onlyReceive only standard dietary therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Malaysian aged 18 to 60 years
- BMI between 18.5 and 39.9 kg/m2
- Not on any weight loss therapy
- Is able to commit to 12 weeks of either intervention
- Presented signs of metabolic syndrome or moderate hypercholesterolemia
Key exclusion criteria (6 listed)
- Those who are pregnant or lactating
- Had undergone bariatric surgery
- Who have acute illnesses such as flu
- Who has any diabetes-related chronic complications except hypertension and hyperlipidemia
- Having chronic diseases in particular cancer, liver, kidney, heart disease, stroke, or psychiatric illness
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 |
|---|---|---|
| Plant OmegaA commercial plant-based omega-3 beverage consumed once daily during breakfast | Dietary supplement | Treatment |
| Dietary therapy onlyStandard dietary therapy | Other | Control |
Primary outcome
Changes in lipid profile after 12 weeks intervention of plant based omega 3
Time frame: Baseline and Week 12
Changes in the lipid profile level of LDL, HDL, total cholesterol, triglyceride using standard metric (mmol/L)
Changes in the blood pressure after 12 weeks intervention of plant based omega 3
Time frame: Baseline and Week 12
Changes in both systolic and diastolic blood pressure using the standard unit (mmHg)
Changes in microarray gene expression profile in blood from individual with CVD risk
Time frame: Baseline and Week 12
Changes in microarray gene expression profile in blood from individual with CVD risk, in response to the 12 weeks intake of plant based omega 3
4 secondary outcomes
Changes in anti-inflammatory effect of plant-based omega-3 after 12 weeks
Time frame: Baseline, Week 12
Changes in fasting blood glucose after 12 weeks intervention of plant based omega-3
Time frame: Baseline, Week 12
Changes in glycated hemoglobin after 12 weeks intervention of plant based omega-3
Time frame: Baseline, Week 12
Changes in quality of life of individuals with CVD risk, before and after the consumption of plant-based omega 3 for 12 weeks
Time frame: Baseline, Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Results publication: PubMed 33184632Schmidt KA, Cromer G, Burhans MS, Kuzma JN, Hagman DK, Fernando I, Murray M, Utzschneider KM, Holte S, Kraft J, Kratz M. The impact of diets rich in low-fat or full-fat dairy on glucose tolerance and its determinants: a randomized controlled trial. Am J Clin Nutr. 2021 Mar 11;113(3):534-547. doi: 10.1093/ajcn/nqaa301.
- Results publication: PubMed 24063257Tovar J, Nilsson A, Johansson M, Bjorck I. Combining functional features of whole-grain barley and legumes for dietary reduction of cardiometabolic risk: a randomised cross-over intervention in mature women. Br J Nutr. 2014 Feb;111(4):706-14. doi: 10.1017/S000711451300305X. Epub 2013 Sep 24.
- 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.
Yoke Kqueen Cheah principal investigator
Universiti Putra Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant Omega and Dietary therapy only in people with Cardiovascular Risk, run by Universiti Putra Malaysia at 1 site in Malaysia.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 16 Dec 2024. 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 Malaysia. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soon Peng Gew (+60162101615, gew_sp@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in lipid profile after 12 weeks intervention of plant based omega 3 (time frame: Baseline and Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05882266, which also lists 2 linked publications.
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 16 Dec 2024.