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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postmenopausal Disorder

Intervention / Treatment
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* Dietary Supplement: b-cryptoxanthin and phytosterols


Participation Criteria
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Eligibility Criteria
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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,...)

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: b-cryptoxanthin<br> | Dietary Supplement: b-cryptoxanthin and phytosterols<br>* 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.<br>* Other names: carotenoids, plant sterols;|
| Experimental: phytosterols<br> | Dietary Supplement: b-cryptoxanthin and phytosterols<br>* 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.<br>* Other names: carotenoids, plant sterols;|
| Experimental: b-cryptoxanthin plus phytosterols<br> | Dietary Supplement: b-cryptoxanthin and phytosterols<br>* 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.<br>* Other names: carotenoids, plant sterols;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum b-cryptoxanthin |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Cardiovascular risk markers |  | 4 weeks | 
| Serum bone markers |  | 4 weeks | 
| Genetic variability (polymorphisms)and DNA oxidative damage |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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b-cryptoxanthin, cholesterol, bone markers, Osteoporosis, cardiovascular risk, post-menopausal women