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

April 6, 2018 updated by: Fernando Granado Lorencio, Puerta de Hierro University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Majadahonda (Madrid), Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro-Majadahonda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Post-menopausal women; mild hypercholesterolemia

Exclusion Criteria:

  • Use of cholesterol lowering drugs, hormonal therapy, vitamin and herbs supplements use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: b-cryptoxanthin plus phytosterols
Fruit and milk based beverage enriched with b-cryptoxanthin and phytosterols
Dietary supplement: b-cryptoxanthin plus phytosterols
PLACEBO_COMPARATOR: control
Fruit and milk based beverage not enriched
Dietary supplement: b-cryptoxanthin plus phytosterols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum response of B-cryptoxanthin
Time Frame: 6 weeks of intervention
6 weeks of intervention
Serum response of phytosterols
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum lipid profile
Time Frame: 6 weks of intervention
6 weks of intervention
bone resorption markers
Time Frame: 6 weeks
6 weeks
interleukins
Time Frame: 6 weeks
6 weeks
Serum C-reactive protein
Time Frame: 6 weeks
6 weeks
Bone formation markers
Time Frame: 6 weeks
6 weeks
Sterols faecal levels
Time Frame: 6 weeks
6 weeks
Erythrocytes for eryptosis evaluation
Time Frame: 6 weeks
6 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Intestinal transporters polymorphisms,
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Puerta de Hierro University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

February 7, 2014

First Submitted That Met QC Criteria

February 14, 2014

First Posted (ESTIMATE)

February 17, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 10, 2018

Last Update Submitted That Met QC Criteria

April 6, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGL2012-39503-C02-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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