NCT04545463

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 11, 2020

Completed
Last Updated

September 11, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

September 2, 2020

Last Update Submit

September 10, 2020

Conditions

Hypercholesterolemia

Keywords

FiberCholesterol

Outcome Measures

Primary Outcomes (1)

  • Blood HDL-cholesterol

    Cholesterol content in HDL lipoproteins determined by nuclear magnetic resonance

    2 months

Secondary Outcomes (3)

  • Blood lipid profile

    2 months

  • Blood lipoprotein number

    2 months

  • Blood lipoprotein size

    2 months

Study Arms (3)

Insoluble Fibre

ACTIVE COMPARATOR

Cookies with insoluble fibre (wheat bran)

Dietary Supplement: INSOLUBLE

Soluble Fibre

ACTIVE COMPARATOR

Cookies with soluble fibre (Psyllium plantago)

Dietary Supplement: SOLUBLE

FIBRACEP

EXPERIMENTAL

Cookies with FIBRACEP

Dietary Supplement: FIBRACEP

Interventions

FIBRACEPDIETARY_SUPPLEMENT

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

Also known as: Onion fiber
FIBRACEP
INSOLUBLEDIETARY_SUPPLEMENT

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

Also known as: Insoluble fibre from wheat bran
Insoluble Fibre
SOLUBLEDIETARY_SUPPLEMENT

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

Also known as: Soluble fibre from Psyllium plantago
Soluble Fibre

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Type 1 and Type 2 Diabetes
  • Allergy to any compound described in FIBRACEP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

José Serrano Casasola

Lleida, 25198, Spain

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 2, 2020

First Posted

September 11, 2020

Study Start

May 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

September 11, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

By request to Principal Investigator

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
January 2021, for 2 years.
Access Criteria
By e-mail to Principal Investigator, who will decide to share the data if fulfill research purposes.

Locations

ES(1)