Back to resultsHypocholesterolemic Effect of Fibracep (FIBRACEP)
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
FIBRACEP
INSOLUBLE
SOLUBLE
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring Fiber, Cholesterol
Eligibility 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
Sites / Locations
- José Serrano Casasola
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Insoluble Fibre
Soluble Fibre
FIBRACEP
Arm Description
Cookies with insoluble fibre (wheat bran)
Cookies with soluble fibre (Psyllium plantago)
Cookies with FIBRACEP
Outcomes
Primary Outcome Measures
Blood HDL-cholesterol
Cholesterol content in HDL lipoproteins determined by nuclear magnetic resonance
Secondary Outcome Measures
Blood lipid profile
Cholesterol content in LDL, VLDL (Very low-density lipoproteins) density and IDL lipoproteins determined by NMR
Blood lipoprotein number
Number of lipoproteins determined by nuclear magnetic resonance
Blood lipoprotein size
The average size of each lipoprotein specie (HDL, LDL, VLDL, IDL) determined by nuclear magnetic resonance
Full Information
NCT ID
NCT04545463
First Posted
September 2, 2020
Last Updated
September 10, 2020
Sponsor
Universitat de Lleida
1. Study Identification
Unique Protocol Identification Number
NCT04545463
Brief Title
Hypocholesterolemic Effect of Fibracep
Acronym
FIBRACEP
Official Title
Validation Study of the Effects of FIBRACEP Supplementation on the Lipid Profile
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2015 (Actual)
Primary Completion Date
May 1, 2016 (Actual)
Study Completion Date
May 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat de Lleida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Fiber, Cholesterol
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insoluble Fibre
Arm Type
Active Comparator
Arm Description
Cookies with insoluble fibre (wheat bran)
Arm Title
Soluble Fibre
Arm Type
Active Comparator
Arm Description
Cookies with soluble fibre (Psyllium plantago)
Arm Title
FIBRACEP
Arm Type
Experimental
Arm Description
Cookies with FIBRACEP
Intervention Type
Dietary Supplement
Intervention Name(s)
FIBRACEP
Other Intervention Name(s)
Onion fiber
Intervention Description
A total intake of 7 g/day of FIBRACEP (provided in 6 cookies of 15 g/each) during two months
Intervention Type
Dietary Supplement
Intervention Name(s)
INSOLUBLE
Other Intervention Name(s)
Insoluble fibre from wheat bran
Intervention Description
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
Intervention Name(s)
SOLUBLE
Other Intervention Name(s)
Soluble fibre from Psyllium plantago
Intervention Description
A total intake of 7 g/day of psyllium plantago (provided in 6 cookies of 15g/each) during two months
Primary Outcome Measure Information:
Title
Blood HDL-cholesterol
Description
Cholesterol content in HDL lipoproteins determined by nuclear magnetic resonance
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Blood lipid profile
Description
Cholesterol content in LDL, VLDL (Very low-density lipoproteins) density and IDL lipoproteins determined by NMR
Time Frame
2 months
Title
Blood lipoprotein number
Description
Number of lipoproteins determined by nuclear magnetic resonance
Time Frame
2 months
Title
Blood lipoprotein size
Description
The average size of each lipoprotein specie (HDL, LDL, VLDL, IDL) determined by nuclear magnetic resonance
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
José Serrano Casasola
City
Lleida
ZIP/Postal Code
25198
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Hypocholesterolemic Effect of Fibracep
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