Hypocholesterolemic Effect of Fibracep

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Dietary Supplement: INSOLUBLE; Dietary Supplement: SOLUBLE; Dietary Supplement: FIBRACEP

• Registration Number: NCT04545463
• Lead Sponsor: Universitat de Lleida

Brief Summary

FIBRACEP is an onion based fiber that has demonstrated in vitro and in animal models the capacity to increase HDL cholesterol levels as well to improve other lipid profile species. This intervention aims to demonstrate FIBRACEP's blood lipid profile improvement effect. For that purpose, hypercholesterolemic subjects will be recruited and given a daily dose of 7 g of FIBRACEP for two months. Changes in blood lipid profile will be the end-point of the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-01
• Primary Completion: 2016-05-01
• Study Completion: 2016-05-01
• Status Verified: 2020-09
• Study First Submitted: 2020-09-02
• Study First Submitted QC: 2020-09-10
• Last Update Submitted: 2020-09-10
• Study First Posted: 2020-09-11
• Last Update Posted: 2020-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Total cholesterol levels above 200 mg/dL, observed in at least 3 different days
• Body mass index between 25 and 35 (Overweight and obesity type 1 diagnosis)

Exclusion Criteria

• Type 1 and Type 2 Diabetes
• Allergy to any compound described in FIBRACEP

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insoluble Fibre	INSOLUBLE	Cookies with insoluble fibre (wheat bran)
Soluble Fibre	SOLUBLE	Cookies with soluble fibre (Psyllium plantago)
FIBRACEP	FIBRACEP	Cookies with FIBRACEP

Primary Outcome Measures

Name	Time	Method
Blood HDL-cholesterol	2 months	Cholesterol content in HDL lipoproteins determined by nuclear magnetic resonance

Secondary Outcome Measures

Name	Time	Method
Blood lipoprotein number	2 months	Number of lipoproteins determined by nuclear magnetic resonance
Blood lipoprotein size	2 months	The average size of each lipoprotein specie (HDL, LDL, VLDL, IDL) determined by nuclear magnetic resonance
Blood lipid profile	2 months	Cholesterol content in LDL, VLDL (Very low-density lipoproteins) density and IDL lipoproteins determined by NMR

Trial Locations

Locations (1)

José Serrano Casasola; 🇪🇸 Lleida, Spain