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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Plant Omega
Dietary supplementA commercial plant-based omega-3 beverage consumed once daily during breakfast
Dietary therapy only
Other interventionStandard dietary therapy
Treatment groups
Trial outcomes
Primary outcomes
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)
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)
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
Secondary outcomes
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)
Changes in fasting blood glucose after 12 weeks intervention of plant based omega-3
Changes in fasting blood glucose using standard metric (mmol/L)
Changes in glycated hemoglobin after 12 weeks intervention of plant based omega-3
Changes in glycated hemoglobin (hbA1c) using standard metric (%)
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).
Sponsors and contacts
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Universiti Putra Malaysia
Lead sponsor
Beacon Hospital Sdn Bhd
Collaborator
This trial is not recruiting at the moment. You can still explore other options: