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

University of Putra Malaysia (UPM)

Status: Not yet enrolling

Conditions: Cardiovascular Risk

Treatments: Dietary Supplement: Plant Omega; Other: Dietary therapy only

Study type: Interventional

Funder types: Other

Identifiers

NCT05882266

RSCH ID-23-00839-PGP

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

Receive standard dietary therapy and plant-based omega-3 supplemental beverage consumed once daily during breakfast.

Treatment:

Dietary Supplement: Plant Omega

Control

Placebo Comparator group

Description:

Receive only standard dietary therapy

Treatment:

Other: Dietary therapy only