Food Matrix and Genetic Variability as Determinants of Bioavailability and Biological Effects of Beta-cryptoxanthin and Phytosterols

Study Overview
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Brief Summary
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Regular consumption of a beverage containing β-cryptoxanthin (b-Cx) and plant sterols (Ps) has been shown to exert a synergic effect in reducing cardiovascular risk and bone remodeling markers (formation and resorption). The present project aims to assess the influence of technological treatment and genetic variability on the bioavailability and the health effects of the added components (Ps, b-Cx), in particular to their potential role in prevalent disorders.In vitro and in vivo studies will be carried out to this effect. In vitro and in vivo studies (human intervention study) will be performed and cardiovascular, bone turnover and inflammation markers will be evaluated. Additionally, an in vitro colonic fermentation model and cell cultures will be used to explore anticarcinogenic effects and potential cytotoxicity.

Official Title
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Food Matrix and Genetic Variability as Determinants of the Bioavailability and Biological Effects of a B-cryptoxanthin and Phytosterols-enriched Beverage; In Vitro and in Vivo Evaluation

Conditions
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Hypercholesterolemia, Osteoporosis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-menopausal women; mild hypercholesterolemia Exclusion Criteria: Use of cholesterol lowering drugs, hormonal therapy, vitamin and herbs supplements use

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 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 |
| --- | --- |
| Active Comparator: b-cryptoxanthin plus phytosterols<br>Fruit and milk based beverage enriched with b-cryptoxanthin and phytosterols | Dietary Supplement: b-cryptoxanthin plus phytosterols<br> <br> |
| Placebo Comparator: control<br>Fruit and milk based beverage not enriched | Dietary Supplement: b-cryptoxanthin plus phytosterols<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum response of B-cryptoxanthin |  | 6 weeks of intervention | 
| Serum response of phytosterols |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum lipid profile |  | 6 weks of intervention | 
| bone resorption markers |  | 6 weeks | 
| interleukins |  | 6 weeks | 
| Serum C-reactive protein |  | 6 weeks | 
| Bone formation markers |  | 6 weeks | 
| Sterols faecal levels |  | 6 weeks | 
| Erythrocytes for eryptosis evaluation |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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b-cryptoxanthin, plant sterols, serum Cholesterol, bone turnover markers