The Role of Plant-Based Omega-3 Fatty Acids and Molecular Characterisation in Individuals with Cardiovascular(CVD) Risk
NCT ID: NCT05882266
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
72 participants
INTERVENTIONAL
2024-12-20
2025-12-30
Brief Summary
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* 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
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
* 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
TREATMENT
TRIPLE
Study Groups
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Treatment
Receive standard dietary therapy and plant-based omega-3 supplemental beverage consumed once daily during breakfast.
Plant Omega
A commercial plant-based omega-3 beverage consumed once daily during breakfast
Control
Receive only standard dietary therapy
Dietary therapy only
Standard dietary therapy
Interventions
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Plant Omega
A commercial plant-based omega-3 beverage consumed once daily during breakfast
Dietary therapy only
Standard dietary therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Beacon Hospital Sdn Bhd
OTHER
Universiti Putra Malaysia
OTHER
Responsible Party
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Gew Soon Peng
Principal Investigator
Principal Investigators
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Yoke Kqueen Cheah
Role: PRINCIPAL_INVESTIGATOR
Universiti Putra Malaysia
Locations
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Beacon Hospital Sdn Bhd
Petaling Jaya, Selangor, Malaysia
Countries
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Central Contacts
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Facility Contacts
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Sook Hui Tay
Role: primary
Geeta Appanah, PhD
Role: backup
Syamimi Samah, PhD
Role: backup
Mohd Hamzah Kamaruzaman, FRCS, Md
Role: backup
References
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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.
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.
Other Identifiers
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RSCH ID-23-00839-PGP
Identifier Type: -
Identifier Source: org_study_id