Food Matrix and Genetic Variability as Determinants of Bioavailability and Biological Effects of Beta-cryptoxanthin and Phytosterols

NCT ID: NCT02065024

Last Updated: 2018-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypercholesterolemia Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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b-cryptoxanthin plus phytosterols

Fruit and milk based beverage enriched with b-cryptoxanthin and phytosterols

Group Type ACTIVE_COMPARATOR

b-cryptoxanthin plus phytosterols

Intervention Type DIETARY_SUPPLEMENT

control

Fruit and milk based beverage not enriched

Group Type PLACEBO_COMPARATOR

b-cryptoxanthin plus phytosterols

Intervention Type DIETARY_SUPPLEMENT

Interventions

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b-cryptoxanthin plus phytosterols

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Post-menopausal women; mild hypercholesterolemia

Exclusion Criteria

* Use of cholesterol lowering drugs, hormonal therapy, vitamin and herbs supplements use
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Puerta de Hierro University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Fernando Granado Lorencio

dr Fernando Granado Lorencio

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Universitario Puerta de Hierro-Majadahonda

Majadahonda (Madrid), Madrid, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 30243503 (View on PubMed)

Other Identifiers

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AGL2012-39503-C02-02

Identifier Type: -

Identifier Source: org_study_id

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