Cardiovascular Risk Clinical Trial
Official title:
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
Status | Not yet recruiting |
Enrollment | 72 |
Est. completion date | August 15, 2025 |
Est. primary completion date | July 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Malaysia | Beacon Hospital Sdn Bhd | Petaling Jaya | Selangor |
Lead Sponsor | Collaborator |
---|---|
Universiti Putra Malaysia | Beacon Hospital Sdn Bhd |
Malaysia,
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 C — View Citation
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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) | Baseline, Week 12 | |
Secondary | Changes in fasting blood glucose after 12 weeks intervention of plant based omega-3 | Changes in fasting blood glucose using standard metric (mmol/L) | Baseline, Week 12 | |
Secondary | Changes in glycated hemoglobin after 12 weeks intervention of plant based omega-3 | Changes in glycated hemoglobin (hbA1c) using standard metric (%) | Baseline, Week 12 | |
Secondary | 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). | Baseline, Week 12 |
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