Hypocholesterolemic Effect of Fibracep

Study Overview
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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.

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

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: FIBRACEP
* Dietary Supplement: INSOLUBLE
* Dietary Supplement: SOLUBLE


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fiber, Cholesterol