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

NCT06595472 | Completed

• 1 other identifier: 16-L/IPB/4202
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hyperlipidemias

Keywords

hyperlipidemia; plant sterol; C-reactive protein; Indonesia

Outcome Measures

Primary Outcomes (1)

• Blood lipid profile

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

  8 weeks

Secondary Outcomes (1)

• Inflammatory marker

  8 weeks

Study Arms (2)

plant sterol-enriched palm oil

EXPERIMENTAL

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

Dietary Supplement: Palm Oil Enriched with Plant Sterols

palm oil

PLACEBO COMPARATOR

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

Interventions

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.

plant sterol-enriched palm 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.

palm oil

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• aged 25-60y
• total cholesterol concentration ≥200 mg/dL
• not requiring lipid-lowering drug therapy during the trial

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Pertanian Bogor: lead
• BASF: collaborator

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Phytosterols; Palm Oil

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sterols; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Membrane Lipids; Lipids; Phytochemicals; Biological Factors; Dietary Fats; Fats; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr, Assistant Professor, Principal Investigator, Head of Health and Nutrition Division at Seafast Center IPB

Model Details: 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.

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 19, 2024

Record last verified: 2024-09