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

May 21, 2023 updated by: Gew Soon Peng, Universiti Putra Malaysia

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?

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malaysia
    • Selangor
      • Petaling Jaya, Selangor, Malaysia, 46050
        • Beacon Hospital Sdn Bhd
        • Contact:
        • Sub-Investigator:
          • Geeta Appanah, PhD
        • Sub-Investigator:
          • Syamimi Samah, PhD
        • Sub-Investigator:
          • Mohd Hamzah Kamaruzaman, FRCS, Md

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Receive standard dietary therapy and plant-based omega-3 supplemental beverage consumed once daily during breakfast.
Dietary supplement: Plant Omega
A commercial plant-based omega-3 beverage consumed once daily during breakfast
Placebo Comparator: Control
Receive only standard dietary therapy
Other: Dietary therapy only
Standard dietary therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline and Week 12
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)
Baseline and Week 12
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
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in anti-inflammatory effect of plant-based omega-3 after 12 weeks
Time Frame: Baseline, Week 12
Changes in high-sensitivity C-Reactive Protein (hs-CRP) using standard metric (mg/L)
Baseline, Week 12
Changes in fasting blood glucose after 12 weeks intervention of plant based omega-3
Time Frame: Baseline, Week 12
Changes in fasting blood glucose using standard metric (mmol/L)
Baseline, Week 12
Changes in glycated hemoglobin after 12 weeks intervention of plant based omega-3
Time Frame: Baseline, Week 12
Changes in glycated hemoglobin (hbA1c) using standard metric (%)
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
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).
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Putra Malaysia

Collaborators

Beacon Hospital Sdn Bhd

Investigators

  • Principal Investigator: Yoke Kqueen Cheah, Universiti Putra Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2023

Primary Completion (Estimated)

June 29, 2025

Study Completion (Estimated)

July 15, 2025

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

May 21, 2023

First Posted (Actual)

May 31, 2023

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 21, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RSCH ID-23-00839-PGP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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