HypercholesterolemiaPhase 1foodmagenpolNCT02065024
Food Matrix and Genetic Variability as Determinants of Bioavailability and Biological Effects of Beta-cryptoxanthin and Phytosterols
A Phase 1 study testing b-cryptoxanthin plus phytosterols in people with Hypercholesterolemia and Osteoporosis, run by Puerta de Hierro University Hospital at 1 site in Spain.
Trial summary
Regular consumption of a beverage containing β-cryptoxanthin (b-Cx) and plant sterols (Ps) has been shown to exert a synergic effect in reducing cardiovascular risk and bone remodeling markers (formation and resorption). Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Osteoporosis
- What is being tested?
- b-cryptoxanthin plus phytosterols
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2014to Aug 2015
- Phase
- Phase 1
- 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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Post-menopausal women; mild hypercholesterolemia
Who cannot join
- Use of cholesterol lowering drugs, hormonal therapy, vitamin and herbs supplements use
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda (Madrid), Madrid, 28222
About this study
Official title: Food Matrix and Genetic Variability as Determinants of the Bioavailability and Biological Effects of a B-cryptoxanthin and Phytosterols-enriched Beverage; In Vitro and in Vivo Evaluation
Regular consumption of a beverage containing β-cryptoxanthin (b-Cx) and plant sterols (Ps) has been shown to exert a synergic effect in reducing cardiovascular risk and bone remodeling markers (formation and resorption). The present project aims to assess the influence of technological treatment and genetic variability on the bioavailability and the health effects of the added components (Ps, b-Cx), in particular to their potential role in prevalent disorders.In vitro and in vivo studies will be carried out to this effect. In vitro and in vivo studies (human intervention study) will be performed and cardiovascular, bone turnover and inflammation markers will be evaluated. Additionally, an in vitro colonic fermentation model and cell cultures will be used to explore anticarcinogenic effects and potential cytotoxicity.
- Conditions
- Hypercholesterolemia, Osteoporosis
- Being tested
- b-cryptoxanthin plus phytosterols
- Keywords
- b-cryptoxanthin, plant sterols, serum Cholesterol, bone turnover markers
- Medical subject headings
- Hypercholesterolemia, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
b-cryptoxanthin plus phytosterolsDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| b-cryptoxanthin plus phytosterols | Active comparator | Fruit and milk based beverage enriched with b-cryptoxanthin and phytosterols Receives: Dietary Supplement: b-cryptoxanthin plus phytosterols |
| control | Placebo comparator | Fruit and milk based beverage not enriched Receives: Dietary Supplement: b-cryptoxanthin plus phytosterols |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum response of B-cryptoxanthin
Measured: 6 weeks of intervention
Serum response of phytosterols
Measured: 6 weeks
Secondary outcomes (7)
Serum lipid profile
Measured: 6 weks of intervention
bone resorption markers
Measured: 6 weeks
interleukins
Measured: 6 weeks
Serum C-reactive protein
Measured: 6 weeks
Bone formation markers
Measured: 6 weeks
Sterols faecal levels
Measured: 6 weeks
Erythrocytes for eryptosis evaluation
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Puerta de Hierro University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Granado Lorencio, Puerta de Hierro University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065024
- Sponsor's protocol ID
- AGL2012-39503-C02-02
- Acronym
- foodmagenpol
- Status last verified
- Apr 2018
- First submitted
- 7 Feb 2014
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Cuevas-Tena M, Bermudez JD, Silvestre RLA, Alegria A, Lagarda MJ. Impact of colonic fermentation on sterols after the intake of a plant sterol-enriched beverage: A randomized, double-blind crossover trial. Clin Nutr. 2019 Aug;38(4):1549-1560. doi: 10.1016/j.clnu.2018.08.012. Epub 2018 Sep 7.
PubMed 30243503
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Matrix and Genetic Variability as Determinants of the Bioavailability and Biological Effects of a B-cryptoxanthin and Phytosterols-enriched Beverage; In Vitro and in Vivo Evaluation
- ClinicalTrials.gov ID
- NCT02065024
- Acronym / sponsor ID
- foodmagenpol / AGL2012-39503-C02-02
- Conditions
- Hypercholesterolemia, Osteoporosis
- Keywords
- b-cryptoxanthin, plant sterols, serum Cholesterol, bone turnover markers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Puerta de Hierro University HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 17 Feb 2014 (estimated)
- 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.
Regular consumption of a beverage containing β-cryptoxanthin (b-Cx) and plant sterols (Ps) has been shown to exert a synergic effect in reducing cardiovascular risk and bone remodeling markers (formation and resorption). The present project aims to assess the influence of technological treatment and genetic variability on the bioavailability and the health effects of the added components (Ps, b-Cx), in particular to their potential role in prevalent disorders.In vitro and in vivo studies will be carried out to this effect. In vitro and in vivo studies (human intervention study) will be performed and cardiovascular, bone turnover and inflammation markers will be evaluated. Additionally, an in vitro colonic fermentation model and cell cultures will be used to explore anticarcinogenic effects and potential cytotoxicity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| b-cryptoxanthin plus phytosterols | Active comparator | Dietary Supplement: b-cryptoxanthin plus phytosterolsFruit and milk based beverage enriched with b-cryptoxanthin and phytosterols |
| control | Placebo comparator | Dietary Supplement: b-cryptoxanthin plus phytosterolsFruit and milk based beverage not enriched |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Post-menopausal women; mild hypercholesterolemia
Key exclusion criteria (1 listed)
- Use of cholesterol lowering drugs, hormonal therapy, vitamin and herbs supplements use
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 |
|---|---|---|
| b-cryptoxanthin plus phytosterols | Dietary supplement | b-cryptoxanthin plus phytosterols, control |
Primary outcome
serum response of B-cryptoxanthin
Time frame: 6 weeks of intervention
Serum response of phytosterols
Time frame: 6 weeks
7 secondary outcomes
Serum lipid profile
Time frame: 6 weks of intervention
bone resorption markers
Time frame: 6 weeks
interleukins
Time frame: 6 weeks
Serum C-reactive protein
Time frame: 6 weeks
Bone formation markers
Time frame: 6 weeks
Sterols faecal levels
Time frame: 6 weeks
Erythrocytes for eryptosis evaluation
Time frame: 6 weeks
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 10 Apr 2018.
- Derived from this study: PubMed 30243503Cuevas-Tena M, Bermudez JD, Silvestre RLA, Alegria A, Lagarda MJ. Impact of colonic fermentation on sterols after the intake of a plant sterol-enriched beverage: A randomized, double-blind crossover trial. Clin Nutr. 2019 Aug;38(4):1549-1560. doi: 10.1016/j.clnu.2018.08.012. Epub 2018 Sep 7.
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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 Phase 1 study testing b-cryptoxanthin plus phytosterols in people with Hypercholesterolemia and Osteoporosis, run by Puerta de Hierro University Hospital 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 1 inclusion and 1 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 10 Apr 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
serum response of B-cryptoxanthin (time frame: 6 weeks of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02065024, which also lists 1 linked publication.
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 10 Apr 2018.