Bioavailability of Added B-cryptoxanthin and Phytosterols; In Vitro and in Vivo Interactions and Effect on Bone Remodelling and Cardiovascular Risk Markers
| Registry | NCT01074723 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, crossover, masking: double, basic science |
| Enrollment | 36 (Actual) |
| Sponsor | Puerta de Hierro University Hospital (Other) |
| Conditions | Postmenopausal Disorder |
| Interventions | b-cryptoxanthin and phytosterols (Dietary supplement) |
| Dates | start 2010-02-01, primary completion 2010-07-01, completion 2012-12-01, first posted 2010-02-24, last updated 2014-02-10 |
| Locations | 1 site in Spain |
Related Papers Related Patents Related Grants Related Experts
All trials for Postmenopausal Disorder All trials of b-cryptoxanthin and phytosterols
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| b-cryptoxanthin | Experimental | Dietary Supplement: b-cryptoxanthin and phytosterols | |
| phytosterols | Experimental | Dietary Supplement: b-cryptoxanthin and phytosterols | |
| b-cryptoxanthin plus phytosterols | Experimental | Dietary Supplement: b-cryptoxanthin and phytosterols |
Sex: Female, ages: 45 Years to 60 Years, accepts healthy volunteers
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,...)
| Facility | City | Country | Status |
|---|---|---|---|
| Puerta de Hierro University Hospital | Madrid, Madrid | Spain |