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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02065024

Acronym

foodmagenpol

Enrollment

Registered

2014-02-17

Start date

2014-03-31

Completion date

2015-08-31

Last updated

2018-04-10

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

Conditions

Hypercholesterolemia, Osteoporosis

Keywords

b-cryptoxanthin, plant sterols, serum Cholesterol, bone turnover markers

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTb-cryptoxanthin plus phytosterols

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Post-menopausal women; mild hypercholesterolemia

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Serum response of phytosterols	6 weeks
serum response of B-cryptoxanthin	6 weeks of intervention

Secondary

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

Other

Measure	Time frame
Intestinal transporters polymorphisms,	Baseline

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026