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OpenTrials
Completed

NCT Number: NCT04545463

Hypocholesterolemic Effect of Fibracep

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

José Serrano Casasola

Lleida, 25198, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FIBRACEP

Dietary Supplement

A total intake of 7 g/day of FIBRACEP (provided in 6 cookies of 15 g/each) during two months

Other names: Onion fiber

INSOLUBLE

Dietary Supplement

A total intake of 7 g/day of wheat bran (provided in 6 cookies of 15 g/each) during two months

Other names: Insoluble fibre from wheat bran

SOLUBLE

Dietary Supplement

A total intake of 7 g/day of psyllium plantago (provided in 6 cookies of 15g/each) during two months

Other names: Soluble fibre from Psyllium plantago

Primary outcomes

  1. Blood HDL-cholesterol

    Time frame: 2 months

    Cholesterol content in HDL lipoproteins determined by nuclear magnetic resonance

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Universitat de Lleida

Other

Registry information

Official study title

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

Acronym: FIBRACEP

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 11, 2020
Registry last updated
Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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