NCT06595472

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Institut Pertanian Bogor · Academic / Other
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperlipidemias

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-06-01
• Completion: 2013-12-01
• First posted: 2024-09-19
• Last updated: 2024-09-19