Hypocholesterolemic Effect of Fibracep

Validation Study of the Effects of FIBRACEP Supplementation on the Lipid Profile

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04545463

Acronym

FIBRACEP

Enrollment

Registered

2020-09-11

Start date

2015-05-01

Completion date

2016-05-01

Last updated

2020-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

Fiber, Cholesterol

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.

Interventions

DIETARY_SUPPLEMENTINSOLUBLE

A total intake of 7 g/day of wheat bran (provided in 6 cookies of 15 g/each) during two months

DIETARY_SUPPLEMENTFIBRACEP

A total intake of 7 g/day of FIBRACEP (provided in 6 cookies of 15 g/each) during two months

DIETARY_SUPPLEMENTSOLUBLE

A total intake of 7 g/day of psyllium plantago (provided in 6 cookies of 15g/each) during two months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Blood HDL-cholesterol	2 months	Cholesterol content in HDL lipoproteins determined by nuclear magnetic resonance

Secondary

Measure	Time frame	Description
Blood lipid profile	2 months	Cholesterol content in LDL, VLDL (Very low-density lipoproteins) density and IDL lipoproteins determined by NMR
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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026