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NCT04545463 Clinical Trial

Hypocholesterolemic Effect of Fibracep

Hypercholesterolemia Clinical Trial

— FIBRACEP  

Official title:
Validation Study of the Effects of FIBRACEP Supplementation on the Lipid Profile

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04545463
Other study ID # CEIC-1534
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2015
Est. completion date May 1, 2016

Study information
Verified date September 2020
Source Universitat de Lleida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date May 1, 2016
Est. primary completion date May 1, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• FIBRACEP
A total intake of 7 g/day of FIBRACEP (provided in 6 cookies of 15 g/each) during two months
• INSOLUBLE
A total intake of 7 g/day of wheat bran (provided in 6 cookies of 15 g/each) during two months
• SOLUBLE
A total intake of 7 g/day of psyllium plantago (provided in 6 cookies of 15g/each) during two months

Locations
Country Name City State
Spain José Serrano Casasola Lleida

Sponsors (1)
Lead Sponsor Collaborator
Universitat de Lleida

Country where clinical trial is conducted

Spain, 

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