Hypocholesterolemic Effect of Fibracep (FIBRACEP)

Universitat de Lleida

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: INSOLUBLE; Dietary Supplement: SOLUBLE; Dietary Supplement: FIBRACEP

Study type: Interventional

Funder types: Other

Identifiers

NCT04545463

CEIC-1534

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

90 participants in 3 patient groups

Insoluble Fibre

Active Comparator group

Description:

Cookies with insoluble fibre (wheat bran)

Treatment:

Dietary Supplement: INSOLUBLE

Soluble Fibre

Active Comparator group

Description:

Cookies with soluble fibre (Psyllium plantago)

Treatment:

Dietary Supplement: SOLUBLE

FIBRACEP

Experimental group

Description:

Cookies with FIBRACEP

Treatment:

Dietary Supplement: FIBRACEP