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

Effect of Plant Sterol-Enriched Palm Oil on Lipid Profile and Systemic Inflammation in Hyperlipidemic Adults: A Placebo-Controlled Double-Blinded Trial

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).

Study Overview

• Status: Completed
• Conditions: Hyperlipidemias
• Intervention / Treatment: Dietary supplement: Palm Oil Enriched with Plant Sterols; Dietary supplement: Palm oil

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 Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: plant sterol-enriched palm oil; The group given cooking oil (palm oil) which is Enriched with Plant Sterol.	Dietary supplement: Palm Oil Enriched with Plant Sterols; The enriched palm oil contained 52 mg/L of phytosterols, to reach the estimated intake of plant sterols in the treatment group at the level of around 2 g/day [22]. The phytosterols used was Vegapure 95 FF® derived from soybean derivatives containing campesterol, stigmasterol and beta-sitosterol. The oil is consumed by respondents as cooking oil.
Placebo Comparator: 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.	Dietary supplement: Palm oil; The type, composition, and physical appearance of the oil is the same as those of the intervention arm, except that it was not added plant sterol. The oil is consumed by respondents as cooking oil.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood lipid profile	Concentration of blood HDL, LDL, triacylglycerols, and cholesterol (total) of participants after intervention period.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory marker	Concentration of high sensitivity C-Reactive protein of participants after intervention period.	8 weeks

Collaborators and Investigators

• Sponsor: Institut Pertanian Bogor
• Collaborators: BASF

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: September 11, 2024
• First Posted (Estimated): September 13, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 14, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: C-reactive protein; Indonesia; hyperlipidemia; plant sterol
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Inflammation; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: 16-L/IPB/4202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No