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Completed

NCT Number: NCT06595472

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

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).

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Key information

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Palm Oil Enriched with Plant Sterols

Dietary Supplement

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.

Palm oil

Dietary Supplement

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.

Primary outcomes

  1. Blood lipid profile

    Time frame: 8 weeks

    Concentration of blood HDL, LDL, triacylglycerols, and cholesterol (total) of participants after intervention period.

Secondary outcomes

  1. Inflammatory marker

    Time frame: 8 weeks

    Concentration of high sensitivity C-Reactive protein of participants after intervention period.

Sponsors and collaborators

Lead sponsor

Institut Pertanian Bogor

Other

Collaborators

  • BASF

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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