HypercholesterolemiaFIBRACEPNCT04545463
Hypocholesterolemic Effect of Fibracep
A study testing FIBRACEP, INSOLUBLE and SOLUBLE in people with Hypercholesterolemia, run by Universitat de Lleida at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- FIBRACEP, INSOLUBLE and SOLUBLE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2015to 1 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Type 1 and Type 2 Diabetes
- Allergy to any compound described in FIBRACEP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation Study of the Effects of FIBRACEP Supplementation on the Lipid Profile
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.
- Conditions
- Hypercholesterolemia
- Being tested
- FIBRACEP, INSOLUBLE, SOLUBLE
- Keywords
- Fiber, Cholesterol
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIBRACEPDietary supplement
Also called Onion fiber
A total intake of 7 g/day of FIBRACEP (provided in 6 cookies of 15 g/each) during two months
INSOLUBLEDietary supplement
Also called Insoluble fibre from wheat bran
A total intake of 7 g/day of wheat bran (provided in 6 cookies of 15 g/each) during two months
SOLUBLEDietary supplement
Also called Soluble fibre from Psyllium plantago
A total intake of 7 g/day of psyllium plantago (provided in 6 cookies of 15g/each) during two months
| Study group | Role | What they receive |
|---|---|---|
| Insoluble Fibre | Active comparator | Cookies with insoluble fibre (wheat bran) Receives: Dietary Supplement: INSOLUBLE |
| Soluble Fibre | Active comparator | Cookies with soluble fibre (Psyllium plantago) Receives: Dietary Supplement: SOLUBLE |
| FIBRACEP | Experimental | Cookies with FIBRACEP Receives: Dietary Supplement: FIBRACEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood HDL-cholesterol
Cholesterol content in HDL lipoproteins determined by nuclear magnetic resonance
Measured: 2 months
Secondary outcomes (3)
Blood lipid profile
Cholesterol content in LDL, VLDL (Very low-density lipoproteins) density and IDL lipoproteins determined by NMR
Measured: 2 months
Blood lipoprotein number
Number of lipoproteins determined by nuclear magnetic resonance
Measured: 2 months
Blood lipoprotein size
The average size of each lipoprotein specie (HDL, LDL, VLDL, IDL) determined by nuclear magnetic resonance
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start1 May 2015
- Primary completion1 May 2016
- Study completion1 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat de Lleida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Serrano, Universitat de Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545463
- Sponsor's protocol ID
- CEIC-1534
- Acronym
- FIBRACEP
- Status last verified
- Sep 2020
- First submitted
- 2 Sep 2020
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: By request to Principal Investigator
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study of the Effects of FIBRACEP Supplementation on the Lipid Profile
- ClinicalTrials.gov ID
- NCT04545463
- Acronym / sponsor ID
- FIBRACEP / CEIC-1534
- Conditions
- Hypercholesterolemia
- Keywords
- Fiber, Cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universitat de LleidaUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 1 May 2016 (actual)
- Study completion
- 1 May 2016 (actual)
- First posted
- 11 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Insoluble Fibre | Active comparator | Dietary Supplement: INSOLUBLECookies with insoluble fibre (wheat bran) |
| Soluble Fibre | Active comparator | Dietary Supplement: SOLUBLECookies with soluble fibre (Psyllium plantago) |
| FIBRACEP | Experimental | Dietary Supplement: FIBRACEPCookies with FIBRACEP |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Type 1 and Type 2 Diabetes
- Allergy to any compound described in FIBRACEP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FIBRACEPAlso: Onion fiberA total intake of 7 g/day of FIBRACEP (provided in 6 cookies of 15 g/each) during two months | Dietary supplement | FIBRACEP |
| INSOLUBLEAlso: Insoluble fibre from wheat branA total intake of 7 g/day of wheat bran (provided in 6 cookies of 15 g/each) during two months | Dietary supplement | Insoluble Fibre |
| SOLUBLEAlso: Soluble fibre from Psyllium plantagoA total intake of 7 g/day of psyllium plantago (provided in 6 cookies of 15g/each) during two months | Dietary supplement | Soluble Fibre |
Primary outcome
Blood HDL-cholesterol
Time frame: 2 months
Cholesterol content in HDL lipoproteins determined by nuclear magnetic resonance
3 secondary outcomes
Blood lipid profile
Time frame: 2 months
Blood lipoprotein number
Time frame: 2 months
Blood lipoprotein size
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Individual participant dataSharing planned: Yes. By request to Principal Investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIBRACEP, INSOLUBLE and SOLUBLE in people with Hypercholesterolemia, run by Universitat de Lleida at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood HDL-cholesterol (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020; AzTrials last refreshed its copy on 4 Nov 2026.