Plant Sterol-Enriched Palm Oil to Improve Lipid Profile and Inflammation in Hyperlipidemic Individuals

Not Applicable

Completed

• Conditions: Hyperlipidemias
• Interventions: Dietary Supplement: Palm Oil Enriched with Plant Sterols; Dietary Supplement: Palm oil

• Registration Number: NCT06595472
• Lead Sponsor: Institut Pertanian Bogor

Brief Summary

This is a placebo-controlled double-blinded trial aimed to evaluate the effect of palm oil enriched with plant sterols on lipid profile and systemic inflammation marker in 100 adult hyperlipidemic residents of Bogor, Indonesia. Subjects were assigned to intervention oil which contained plant sterol and control oil which was the same as the intervention oil but did not contain plant sterol for 8 weeks. Data collected included nutritional status, energy and macronutrients consumption, blood lipid profile and inflammatory marker (hsCRP).

Detailed Description

Cardiovascular diseases, including coronary heart disease (CHD), are currently positioned amongst the leading causes of mortality globally. Risk factors of CHD include, among others, hypercholesterolemia and elevations in systemic inflammation. Functional foods enriched with compounds showing cholesterol-lowering effects are considered as one among various dietary and lifestyle intervention strategies to tackle this problem. A CHD-preventive effect of dietary plant sterols has been broadly discussed, not only due to their ability to reduce blood cholesterol level, but also to their proven anti-inflammatory potential. Palm oil is one amongst the most widely consumed edible oils in the world. Up to date, despite its widespread use, especially in Asian countries, no study has been conducted using palm oil as a vehicle for plant sterols. The aim of the placebo-controlled double-blinded trial presented here was therefore to evaluate the effect of palm oil enriched with plant sterols, used as a cooking oil, on lipid profile and systemic inflammation marker in 100 adult hyperlipidemic residents of Bogor, Indonesia. The study had 2 arms; intervention group in which subjects were given oil which contained plant sterol and control group which in which subjects were given the same oil as the intervention group but did not contain plant sterol for 8 weeks. The oil was consumed as cooking oil. Data on energy, macro nutrients, and cooking oil consumption were collected through interviews at baseline, week 2, 4, 6, and endline. Body weight and height measurement for nutritional status assessment and blood sample collection for biomarker analysis was conducted at baseline and endline.

Study Timeline

• Study Start: 2012-06-01
• Primary Completion: 2013-06-01
• Study Completion: 2013-12-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-09
• Study First Submitted QC: 2024-09-11
• Study First Posted: 2024-09-13
• Last Update Submitted: 2024-09-14
• Last Update Posted: 2024-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• aged 25-60y
• total cholesterol concentration ≥200 mg/dL
• not requiring lipid-lowering drug therapy during the trial

Exclusion Criteria

• secondary hyperlipidemia
• fasting triglyceride concentration >3.5 mmol/L
• body mass index >35 kg/m2
• use of any lipid-lowering drug
• suffering from gastrointestinal diseases or severe concomitant diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
plant sterol-enriched palm oil	Palm Oil Enriched with Plant Sterols	The group given cooking oil (palm oil) which is Enriched with Plant Sterol.
palm oil	Palm oil	The group given cooking oil (palm oil) which has the same composition and physical appearance as the intervention oil, but without plant sterol.

Primary Outcome Measures

Name	Time	Method
Blood lipid profile	8 weeks	Concentration of blood HDL, LDL, triacylglycerols, and cholesterol (total) of participants after intervention period.

Secondary Outcome Measures

Name	Time	Method
Inflammatory marker	8 weeks	Concentration of high sensitivity C-Reactive protein of participants after intervention period.