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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-01

Study Completion Date

2013-12-01

Brief Summary

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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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Detailed Description

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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

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Hyperlipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study was designed as a double-blinded randomized controlled trial, with 8 week intervention period, and conducted in Bogor district, West Java, Indonesia. The study subjects were volunteers residing in Bogor city and Bogor district, with known mild-moderate hypercholesterolemia. Subjects were supplied with either control or treatment cooking oil bottle every week, to be consumed as substitution of usually used cooking oil.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

The treatment and control cooking oil were indistinguishable in appearance and taste. The investigators and participants remained blinded to individual subject assignment throughout the study.

Study Groups

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plant sterol-enriched palm oil

The group given cooking oil (palm oil) which is Enriched with Plant Sterol.

Group Type EXPERIMENTAL

Palm Oil Enriched with Plant Sterols

Intervention Type 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

The group given cooking oil (palm oil) which has the same composition and physical appearance as the intervention oil, but without plant sterol.

Group Type PLACEBO_COMPARATOR

Palm oil

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No