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Effect of β-cryptoxanthin (β-Cx), Plant Sterols and Galactooligosaccharides on Systemic and Gastrointestinal Markers

NCT03469518 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-05-09

No results posted yet for this study

Summary

Regular consumption of a beverage containing β-cryptoxanthin (β-Cx) and plant sterols (PS) has been shown to exert a synergic effect in reducing some markers of cardiovascular risk and bone-remodeling (formation and resorption). The present project aims to:

* Evaluate (by in vivo and in vitro studies) the bioavailability of added β-Cx, PS and galactooligosaccharides (GOS) and its stability in the beverage employed in the proposed study.
* Study the biological effect (bioefficacy) associated with the regular consumption of modified milk-based fruit beverages containing β-Cx, PS and GOS in post-menopausal women (target group) by assessing changes in inflammation, cardiovascular and bone turnover biochemical markers.
* Characterize genetic variability (polymorphisms), genetic expression and DNA oxidative damage in the target group as determinants of bioavailability and biological effects of β-Cx, PS and GOS.
* Evaluate the potential prebiotic effect associated to regular consumption of a beverage supplemented with β-Cx, PS and GOS: including "in vitro" studies and characterization of subjects' microbiota and possible microbiota changes associated to the beverage consumption.

Conditions

Interventions

DIETARY_SUPPLEMENT

β-Cx plus PS plus GOS

DIETARY_SUPPLEMENT

β-Cx plus PS

Sponsors & Collaborators

  • Nutrition and Food Science Area, Faculty of Pharmacy, University of Valencia

    collaborator UNKNOWN

  • Global Technology centro, Hero Group

    collaborator UNKNOWN

  • Fundación para la Investigación Biomédica, Hospital Universitario Puerta de Hierro

    collaborator UNKNOWN

  • Puerta de Hierro University Hospital

    lead OTHER

Principal Investigators

  • Fernando Granado Lorencio, PhD · Hospital Universitario Puerta de Hierro-Majadahonda

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-07-31
Completion
2019-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03469518 on ClinicalTrials.gov