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

Phase 1

Completed

• Conditions: Postmenopausal Disorder
• Interventions: Dietary Supplement: b-cryptoxanthin and phytosterols

• Registration Number: NCT01074723
• Lead Sponsor: Puerta de Hierro University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-23
• Study First Submitted QC: 2010-02-23
• Study First Posted: 2010-02-24
• Primary Completion: 2010-07
• Study Completion: 2012-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-07
• Last Update Posted: 2014-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
b-cryptoxanthin	b-cryptoxanthin and phytosterols	-
phytosterols	b-cryptoxanthin and phytosterols	-
b-cryptoxanthin plus phytosterols	b-cryptoxanthin and phytosterols	-

Primary Outcome Measures

Name	Time	Method
Serum b-cryptoxanthin	4 weeks

Secondary Outcome Measures

Name	Time	Method
Serum Cardiovascular risk markers	4 weeks
Serum bone markers	4 weeks
Genetic variability (polymorphisms)and DNA oxidative damage	4 weeks

Trial Locations

Locations (1)

Puerta de Hierro University Hospital; 🇪🇸 Madrid, Spain