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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01074723

Enrollment

Registered

2010-02-24

Start date

2010-02-28

Completion date

2012-12-31

Last updated

2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal Disorder

Keywords

b-cryptoxanthin, cholesterol, bone markers, Osteoporosis, cardiovascular risk, post-menopausal women

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.

Interventions

DIETARY_SUPPLEMENTb-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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 60 Years

Healthy volunteers

Yes

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,...)

Design outcomes

Primary

Measure	Time frame
Serum b-cryptoxanthin	4 weeks

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026