Clinical trial NCT01074723: B-cryptoxanthin and Phytosterols on Bone Remodeling and Cardiovascular Risk Factors
Official title: Bioavailability of Added B-cryptoxanthin and Phytosterols; In Vitro and in Vivo Interactions and Effect on Bone Remodelling and Cardiovascular Risk Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postmenopausal Disorder
Keywords: b-cryptoxanthin
cholesterol
bone markers
Osteoporosis
cardiovascular risk
post-menopausal women
Lead sponsor: Puerta de Hierro University Hospital
Sponsor class: OTHER
First posted: 2010-02-24
Enrollment: 36
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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,...)

Primary outcomes:
measure: Serum b-cryptoxanthin
timeFrame: 4 weeks
Secondary outcomes:
measure: Serum Cardiovascular risk markers
timeFrame: 4 weeks
measure: Serum bone markers
timeFrame: 4 weeks
measure: Genetic variability (polymorphisms)and DNA oxidative damage
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Puerta de Hierro University Hospital
Study officials:
References:
citation: Granado-Lorencio F, de Las Heras L, Millan CS, Garcia-Lopez FJ, Blanco-Navarro I, Perez-Sacristan B, Dominguez G. beta-Cryptoxanthin modulates the response to phytosterols in post-menopausal women carrying NPC1L1 L272L and ABCG8 A632 V polymorphisms: an exploratory study. Genes Nutr. 2014 Sep;9(5):428. doi: 10.1007/s12263-014-0428-0. Epub 2014 Aug 28.
citation: Granado-Lorencio F, Lagarda MJ, Garcia-Lopez FJ, Sanchez-Siles LM, Blanco-Navarro I, Alegria A, Perez-Sacristan B, Garcia-Llatas G, Donoso-Navarro E, Silvestre-Mardomingo RA, Barbera R. Effect of beta-cryptoxanthin plus phytosterols on cardiovascular risk and bone turnover markers in post-menopausal women: a randomized crossover trial. Nutr Metab Cardiovasc Dis. 2014 Oct;24(10):1090-6. doi: 10.1016/j.numecd.2014.04.013. Epub 2014 May 6.