B-cryptoxanthin and Phytosterols on Bone Remodeling and Cardiovascular Risk Factors

Postmenopausal Disorder Clinical Trial

Official title:

Bioavailability of Added B-cryptoxanthin and Phytosterols; In Vitro and in Vivo Interactions and Effect on Bone Remodelling and Cardiovascular Risk Markers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01074723
• Other study ID #: AGL-2008-02591-C02-02
• Status: Completed
• Phase: Phase 1
• First received: February 23, 2010
• Last updated: February 7, 2014
• Start date: February 2010
• Est. completion date: December 2012

Study information

• Verified date: February 2014
• Source: Puerta de Hierro University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

We, the investigators, aim to study, in vitro and in vivo, the bioavailability of added b-cryptoxanthin and phytosterols and evaluate in vivo its effect on biochemical markers of bone remodelling and cardiovascular risk. Specifically, we will 1) assess the stability in the food and the bioavailability of b-cryptoxanthin in the presence of phytosterols (absorption modifiers) by using a complementary approach; in vitro and in vivo studies; and 2) we will study in post-menopausal women (target group) the biological effect (bioefficacy) associated with the regular consumption of modified milk-based fruit beverages (containing b-cryptoxanthin and phytosterols) by assessing changes in biochemical markers of bone turnover and cardiovascular risk.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2012
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

Inclusion Criteria:

• Post-menopausal women, 45-60 years old

Exclusion Criteria:

• Dieting

• Food allergy (to any components provided)

• Hormone replacement therapy

• Cholesterol lowering drugs, antiresorptive or anabolic bone drugs

• Calcium and vitamin D supplements

• Soybean products

• Vitamin-mineral supplements

• Fibre supplements

• Commercially available enriched foods (i.e. w-3, phytosterols,carotenoids,...)

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Postmenopausal Disorder

Intervention

Dietary Supplement:
• b-cryptoxanthin and phytosterols
Fruit juices containing b-cryptoxanthin (ca. 1 mg), phytosterols (ca 1.7g) or both will be consumed for 4 weeks with a 4-week washout in between.

Locations

Country	Name	City	State
Spain	Puerta de Hierro University Hospital	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
Primary	Serum b-cryptoxanthin		4 weeks	No
Secondary	Serum Cardiovascular risk markers		4 weeks	No
Secondary	Serum bone markers		4 weeks	No
Secondary	Genetic variability (polymorphisms)and DNA oxidative damage		4 weeks	No