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

Osteoporosis Clinical Trial

— foodmagenpol  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02065024
• Other study ID #: AGL2012-39503-C02-02
• Status: Completed
• Phase: Phase 1
• First received: February 7, 2014
• Last updated: April 6, 2018
• Start date: March 2014
• Est. completion date: August 2015

Study information

• Verified date: April 2018
• Source: Puerta de Hierro University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• Post-menopausal women; mild hypercholesterolemia

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Hypercholesterolemia
• Osteoporosis

Intervention

Dietary Supplement:
• b-cryptoxanthin plus phytosterols

Locations

Country	Name	City	State
Spain	Hospital Universitario Puerta de Hierro-Majadahonda	Majadahonda (Madrid)	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Puerta de Hierro University Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intestinal transporters polymorphisms,		Baseline
Primary	serum response of B-cryptoxanthin		6 weeks of intervention
Primary	Serum response of phytosterols		6 weeks
Secondary	Serum lipid profile		6 weks of intervention
Secondary	bone resorption markers		6 weeks
Secondary	interleukins		6 weeks
Secondary	Serum C-reactive protein		6 weeks
Secondary	Bone formation markers		6 weeks
Secondary	Sterols faecal levels		6 weeks
Secondary	Erythrocytes for eryptosis evaluation		6 weeks