The Role of Plant-Based Omega-3 Fatty Acids and Molecular Characterisation in Individuals With Cardiovascular(CVD) Risk

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversiti Putra Malaysia

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Plant Omega

    Dietary supplement

    A commercial plant-based omega-3 beverage consumed once daily during breakfast

  • Dietary therapy only

    Other intervention

    Standard dietary therapy

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: TreatmentExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Baseline and Week 12
2

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)

Time frame
Baseline and Week 12
3

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

Time frame
Baseline and Week 12

Secondary outcomes

1

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)

Time frame
Baseline, Week 12
2

Changes in fasting blood glucose after 12 weeks intervention of plant based omega-3

Changes in fasting blood glucose using standard metric (mmol/L)

Time frame
Baseline, Week 12
3

Changes in glycated hemoglobin after 12 weeks intervention of plant based omega-3

Changes in glycated hemoglobin (hbA1c) using standard metric (%)

Time frame
Baseline, Week 12
4

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).

Time frame
Baseline, Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universiti Putra Malaysia

Lead sponsor

Beacon Hospital Sdn Bhd

Collaborator

This trial is not recruiting at the moment. You can still explore other options: