Hypocholesterolemic Effect of Fibracep (FIBRACEP)

September 10, 2020 updated by: José Serrano, Universitat de Lleida

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Lleida, Spain, 25198
        • José Serrano Casasola

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Insoluble Fibre
Cookies with insoluble fibre (wheat bran)
Dietary supplement: INSOLUBLE
A total intake of 7 g/day of wheat bran (provided in 6 cookies of 15 g/each) during two months
Other Names:
  • Insoluble fibre from wheat bran
Active Comparator: Soluble Fibre
Cookies with soluble fibre (Psyllium plantago)
Dietary supplement: SOLUBLE
A total intake of 7 g/day of psyllium plantago (provided in 6 cookies of 15g/each) during two months
Other Names:
  • Soluble fibre from Psyllium plantago
Experimental: FIBRACEP
Cookies with FIBRACEP
Dietary supplement: FIBRACEP
A total intake of 7 g/day of FIBRACEP (provided in 6 cookies of 15 g/each) during two months
Other Names:
  • Onion fiber

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat de Lleida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

September 2, 2020

First Submitted That Met QC Criteria

September 10, 2020

First Posted (Actual)

September 11, 2020

Study Record Updates

Last Update Posted (Actual)

September 11, 2020

Last Update Submitted That Met QC Criteria

September 10, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIC-1534

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

By request to Principal Investigator

IPD Sharing Time Frame

January 2021, for 2 years.

IPD Sharing Access Criteria

By e-mail to Principal Investigator, who will decide to share the data if fulfill research purposes.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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