Hypocholesterolemic Effect of Fibracep

NCT ID: NCT04545463

Last Updated: 2020-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-01

Study Completion Date

2016-05-01

Brief Summary

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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

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Insoluble Fibre

Cookies with insoluble fibre (wheat bran)

Group Type ACTIVE_COMPARATOR

INSOLUBLE

Intervention Type DIETARY_SUPPLEMENT

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

Soluble Fibre

Cookies with soluble fibre (Psyllium plantago)

Group Type ACTIVE_COMPARATOR

SOLUBLE

Intervention Type DIETARY_SUPPLEMENT

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

FIBRACEP

Cookies with FIBRACEP

Group Type EXPERIMENTAL

FIBRACEP

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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FIBRACEP

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

Intervention Type DIETARY_SUPPLEMENT

INSOLUBLE

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

Intervention Type DIETARY_SUPPLEMENT

SOLUBLE

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Onion fiber Insoluble fibre from wheat bran Soluble fibre from Psyllium plantago

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitat de Lleida

OTHER

Sponsor Role lead

Responsible Party

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José Serrano

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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José Serrano Casasola

Lleida, , Spain

Site Status

Countries

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Spain

Other Identifiers

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CEIC-1534

Identifier Type: -

Identifier Source: org_study_id

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