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Hypocholesterolemic Effect of Fibracep (FIBRACEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04545463
Recruitment Status : Completed
First Posted : September 11, 2020
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
José Serrano, Universitat de Lleida

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Dietary Supplement: FIBRACEP Dietary Supplement: INSOLUBLE Dietary Supplement: SOLUBLE Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Validation Study of the Effects of FIBRACEP Supplementation on the Lipid Profile
Actual Study Start Date : May 1, 2015
Actual Primary Completion Date : May 1, 2016
Actual Study Completion Date : May 1, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: 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 Name: Onion fiber


Outcome Measures
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Primary Outcome Measures :
  1. Blood HDL-cholesterol [ Time Frame: 2 months ]
    Cholesterol content in HDL lipoproteins determined by nuclear magnetic resonance


Secondary Outcome Measures :
  1. Blood lipid profile [ Time Frame: 2 months ]
    Cholesterol content in LDL, VLDL (Very low-density lipoproteins) density and IDL lipoproteins determined by NMR

  2. Blood lipoprotein number [ Time Frame: 2 months ]
    Number of lipoproteins determined by nuclear magnetic resonance

  3. Blood lipoprotein size [ Time Frame: 2 months ]
    The average size of each lipoprotein specie (HDL, LDL, VLDL, IDL) determined by nuclear magnetic resonance


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04545463


Locations
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Spain
José Serrano Casasola
Lleida, Spain, 25198
Sponsors and Collaborators
Universitat de Lleida
More Information
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Responsible Party: José Serrano, Principal Investigator, Universitat de Lleida
ClinicalTrials.gov Identifier: NCT04545463    
Other Study ID Numbers: CEIC-1534
First Posted: September 11, 2020    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: By request to Principal Investigator
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: January 2021, for 2 years.
Access Criteria: By e-mail to Principal Investigator, who will decide to share the data if fulfill research purposes.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by José Serrano, Universitat de Lleida:
Fiber
Cholesterol
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
 Metabolic Diseases
Psyllium
Cathartics
Gastrointestinal Agents