Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595472
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Plant Sterol-Enriched Palm Oil to Improve Lipid Profile and Inflammation in Hyperlipidemic Individuals
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Plant Sterol-Enriched Palm Oil on Lipid Profile and Systemic Inflammation in Hyperlipidemic Adults A Placebo-Controlled Double-Blinded Trial
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None