Food Matrix and Genetic Variability as Determinants of Bioavailability and Biological Effects of Beta-cryptoxanthin and Phytosterols
foodmagenpol
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2014
CompletedFirst Posted
Study publicly available on registry
February 17, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedApril 10, 2018
April 1, 2018
1.4 years
February 7, 2014
April 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
serum response of B-cryptoxanthin
6 weeks of intervention
Serum response of phytosterols
6 weeks
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Other Outcomes (1)
Intestinal transporters polymorphisms,
Baseline
Study Arms (2)
b-cryptoxanthin plus phytosterols
ACTIVE COMPARATORFruit and milk based beverage enriched with b-cryptoxanthin and phytosterols
control
PLACEBO COMPARATORFruit and milk based beverage not enriched
Interventions
Eligibility Criteria
You may qualify if:
- Post-menopausal women; mild hypercholesterolemia
You may not qualify if:
- Use of cholesterol lowering drugs, hormonal therapy, vitamin and herbs supplements use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda (Madrid), Madrid, 28222, Spain
Related Publications (1)
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.
PMID: 30243503DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- dr Fernando Granado Lorencio
Study Record Dates
First Submitted
February 7, 2014
First Posted
February 17, 2014
Study Start
March 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
April 10, 2018
Record last verified: 2018-04