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

Phase 1

Completed

• Conditions: Hypercholesterolemia; Osteoporosis
• Interventions: Dietary Supplement: b-cryptoxanthin plus phytosterols

• Registration Number: NCT02065024
• Lead Sponsor: Puerta de Hierro University Hospital

Brief 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). 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

Not available

Study Timeline

• Study First Submitted: 2014-02-07
• Study First Submitted QC: 2014-02-14
• Study First Posted: 2014-02-17
• Study Start: 2014-03
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-06
• Last Update Posted: 2018-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Post-menopausal women; mild hypercholesterolemia

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
control	b-cryptoxanthin plus phytosterols	Fruit and milk based beverage not enriched
b-cryptoxanthin plus phytosterols	b-cryptoxanthin plus phytosterols	Fruit and milk based beverage enriched with b-cryptoxanthin and phytosterols

Primary Outcome Measures

Name	Time	Method
serum response of B-cryptoxanthin	6 weeks of intervention
Serum response of phytosterols	6 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Universitario Puerta de Hierro-Majadahonda; 🇪🇸 Majadahonda (Madrid), Madrid, Spain