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

NCT05882266 | Not Yet Recruiting

• 1 other identifier: RSCH ID-23-00839-PGP
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Cardiovascular Risk

Keywords

cvd risk; cardiovascular risk; plant omega; plant based omega 3; omega 3

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  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

  Baseline and Week 12

Secondary Outcomes (4)

• Changes in anti-inflammatory effect of plant-based omega-3 after 12 weeks

  Baseline, Week 12

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

  Baseline, Week 12

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

  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

  Baseline, Week 12

Study Arms (2)

Treatment

EXPERIMENTAL

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

Dietary Supplement: Plant Omega

Control

PLACEBO COMPARATOR

Receive only standard dietary therapy

Other: Dietary therapy only

Interventions

Plant Omega DIETARY_SUPPLEMENT

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

Treatment

Dietary therapy only OTHER

Standard dietary therapy

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead
• Beacon Hospital Sdn Bhd: collaborator

Study Sites (1)

Beacon Hospital Sdn Bhd

Petaling Jaya, Selangor, 46050, Malaysia

Location

Related Publications (2)

• 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.

  PMID: 33184632 BACKGROUND

• Tovar 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.

  PMID: 24063257 BACKGROUND

Study Officials

• Yoke Kqueen Cheah

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soon Peng Gew

CONTACT

+60162101615; gew_sp@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomisation will be done by an independent researcher using block randomisation. No one except the independent researcher will know which group were assigned for each code. The file containing the info for each code will be kept by the independent researcher in Beacon Hospital.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 31, 2023
• Study Start: December 20, 2024
• Primary Completion: August 30, 2025
• Study Completion: December 30, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)