Supplementation of Oil Palm Phenolics in Healthy Subjects

Phase 1

• Conditions: Hypercholesterolemia; Hyperlipidaemia; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12619001786189
• Lead Sponsor: Economic Planning Unit. Prime Minister’s Department. Malaysia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-17
• Last Update Posted: 6 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Healthy, normal levels of lipid profile (Total cholesterol less than 5.2 mmol/dL, LDL cholesterol less than 3.36 mmol/dL, Triglycerides less than 1.69 mmol/dL)

Exclusion Criteria

Smoking, habitual alcohol consumption, consuming antioxidant supplement, pregnant/ breastfeeding, medical history of cardiovascular disease, diabetes, dyslipidemia, current use of antihypertensive or lipid-lowering medication

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is to observe changes in fasting plasma LDL cholesterol level. This will be assessed from the plasma analysis on the fasting blood samples of each volunteer (at day 0, day 30, day 60). [The changes can be observed from the plasma analysis at day 30 and day 60 after supplementation.];Evaluation of the safety and tolerability profile. This will be assessed via kidney function test, liver function test and haematology profile from the plasma analysis on the fasting blood samples of each volunteer (at day 0, day 30, day 60)[The safety and tolerability profile can be observed from the plasma analysis at day 30 and day 60 after supplementation.]