Clinical trial NCT06595472: Plant Sterol-Enriched Palm Oil to Improve Lipid Profile and Inflammation in Hyperlipidemic Individuals
Official title: Effect of Plant Sterol-Enriched Palm Oil on Lipid Profile and Systemic Inflammation in Hyperlipidemic Adults: A Placebo-Controlled Double-Blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemias
Keywords: hyperlipidemia
plant sterol
C-reactive protein
Indonesia
Lead sponsor: Institut Pertanian Bogor
Sponsor class: OTHER
Collaborators: name: BASF
First posted: 2024-09-19
Enrollment: 102
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood lipid profile
timeFrame: 8 weeks
Secondary outcomes:
measure: Inflammatory marker
timeFrame: 8 weeks
Other outcomes:
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