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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| b-cryptoxanthin plus phytosterols | Active Comparator | Fruit and milk based beverage enriched with b-cryptoxanthin and phytosterols |
|
| control | Placebo Comparator | Fruit and milk based beverage not enriched |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| b-cryptoxanthin plus phytosterols | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| serum response of B-cryptoxanthin | 6 weeks of intervention | |
| Serum response of phytosterols | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum lipid profile | 6 weks of intervention | |
| bone resorption markers | 6 weeks | |
| interleukins |
| Measure | Description | Time Frame |
|---|---|---|
| Intestinal transporters polymorphisms, | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Puerta de Hierro-Majadahonda | Majadahonda (Madrid) | Madrid | 28222 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30243503 | Derived | Cuevas-Tena M, Bermudez JD, Silvestre RLA, Alegria A, Lagarda MJ. Impact of colonic fermentation on sterols after the intake of a plant sterol-enriched beverage: A randomized, double-blind crossover trial. Clin Nutr. 2019 Aug;38(4):1549-1560. doi: 10.1016/j.clnu.2018.08.012. Epub 2018 Sep 7. |
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| 6 weeks |
| Serum C-reactive protein | 6 weeks |
| Bone formation markers | 6 weeks |
| Sterols faecal levels | 6 weeks |
| Erythrocytes for eryptosis evaluation | 6 weeks |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D010840 | Phytosterols |
| ID | Term |
|---|---|
| D013261 | Sterols |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D064209 | Phytochemicals |
| D001685 | Biological Factors |
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