Back to resultsFood Matrix and Genetic Variability as Determinants of Bioavailability and Biological Effects of Beta-cryptoxanthin and Phytosterols (foodmagenpol)
Primary Purpose
Hypercholesterolemia, Osteoporosis
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
b-cryptoxanthin plus phytosterols
Sponsored by
About this trial
This is an interventional basic science trial for Hypercholesterolemia focused on measuring b-cryptoxanthin, plant sterols, serum Cholesterol, bone turnover markers
Eligibility Criteria
Inclusion Criteria:
- Post-menopausal women; mild hypercholesterolemia
Exclusion Criteria:
- Use of cholesterol lowering drugs, hormonal therapy, vitamin and herbs supplements use
Sites / Locations
- Hospital Universitario Puerta de Hierro-Majadahonda
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
b-cryptoxanthin plus phytosterols
control
Arm Description
Fruit and milk based beverage enriched with b-cryptoxanthin and phytosterols
Fruit and milk based beverage not enriched
Outcomes
Primary Outcome Measures
serum response of B-cryptoxanthin
Serum response of phytosterols
Secondary Outcome Measures
Serum lipid profile
bone resorption markers
interleukins
Serum C-reactive protein
Bone formation markers
Sterols faecal levels
Erythrocytes for eryptosis evaluation
Full Information
NCT ID
NCT02065024
First Posted
February 7, 2014
Last Updated
April 6, 2018
Sponsor
Puerta de Hierro University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02065024
Brief Title
Food Matrix and Genetic Variability as Determinants of Bioavailability and Biological Effects of Beta-cryptoxanthin and Phytosterols
Acronym
foodmagenpol
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Puerta de Hierro University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Osteoporosis
Keywords
b-cryptoxanthin, plant sterols, serum Cholesterol, bone turnover markers
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
b-cryptoxanthin plus phytosterols
Arm Type
Active Comparator
Arm Description
Fruit and milk based beverage enriched with b-cryptoxanthin and phytosterols
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
Fruit and milk based beverage not enriched
Intervention Type
Dietary Supplement
Intervention Name(s)
b-cryptoxanthin plus phytosterols
Primary Outcome Measure Information:
Title
serum response of B-cryptoxanthin
Time Frame
6 weeks of intervention
Title
Serum response of phytosterols
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Serum lipid profile
Time Frame
6 weks of intervention
Title
bone resorption markers
Time Frame
6 weeks
Title
interleukins
Time Frame
6 weeks
Title
Serum C-reactive protein
Time Frame
6 weeks
Title
Bone formation markers
Time Frame
6 weeks
Title
Sterols faecal levels
Time Frame
6 weeks
Title
Erythrocytes for eryptosis evaluation
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Intestinal transporters polymorphisms,
Time Frame
Baseline
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Post-menopausal women; mild hypercholesterolemia
Exclusion Criteria:
Use of cholesterol lowering drugs, hormonal therapy, vitamin and herbs supplements use
Facility Information:
Facility Name
Hospital Universitario Puerta de Hierro-Majadahonda
City
Majadahonda (Madrid)
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
30243503
Citation
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.
Results Reference
derived
Learn more about this trial
Food Matrix and Genetic Variability as Determinants of Bioavailability and Biological Effects of Beta-cryptoxanthin and Phytosterols
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