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Completed

NCT Number: NCT02065024

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

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.

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Key information

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Hospital Universitario Puerta de Hierro-Majadahonda

Majadahonda (Madrid), Madrid, 28222, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Post-menopausal women; mild hypercholesterolemia

Exclusion criteria

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

Treatment and study plan

b-cryptoxanthin plus phytosterols

Dietary Supplement

Primary outcomes

  1. serum response of B-cryptoxanthin

    Time frame: 6 weeks of intervention

  2. Serum response of phytosterols

    Time frame: 6 weeks

Secondary outcomes

  1. Serum lipid profile

    Time frame: 6 weks of intervention

  2. bone resorption markers

    Time frame: 6 weeks

  3. interleukins

    Time frame: 6 weeks

  4. Serum C-reactive protein

    Time frame: 6 weeks

  5. Bone formation markers

    Time frame: 6 weeks

  6. Sterols faecal levels

    Time frame: 6 weeks

  7. Erythrocytes for eryptosis evaluation

    Time frame: 6 weeks

Other outcomes

  1. Intestinal transporters polymorphisms,

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Puerta de Hierro University Hospital

Other

Registry information

Official study 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

Acronym: foodmagenpol

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 17, 2014
Registry last updated
Apr 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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