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

Majadahonda Iron Gate University

Status and phase: Completed; Phase 1

Conditions: Osteoporosis; Hypercholesterolemia

Treatments: Dietary Supplement: b-cryptoxanthin plus phytosterols

Study type: Interventional

Funder types: Other

Identifiers

NCT02065024

AGL2012-39503-C02-02

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Post-menopausal women; mild hypercholesterolemia

Exclusion criteria

• Use of cholesterol lowering drugs, hormonal therapy, vitamin and herbs supplements use

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

b-cryptoxanthin plus phytosterols

Active Comparator group

Description:

Fruit and milk based beverage enriched with b-cryptoxanthin and phytosterols

Treatment:

Dietary Supplement: b-cryptoxanthin plus phytosterols

control

Placebo Comparator group

Description:

Fruit and milk based beverage not enriched

Treatment:

Dietary Supplement: b-cryptoxanthin plus phytosterols