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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fernando Granado Lorencio, Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier:
NCT02065024
First received: February 7, 2014
Last updated: March 28, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Hypercholesterolemia Osteoporosis Dietary Supplement: b-cryptoxanthin plus phytosterols Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
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

Further study details as provided by Fernando Granado Lorencio, Puerta de Hierro University Hospital:

Primary Outcome Measures:
  • serum response of B-cryptoxanthin [ Time Frame: 6 weeks of intervention ]
  • Serum response of phytosterols [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Serum lipid profile [ Time Frame: 6 weks of intervention ]
  • bone resorption markers [ Time Frame: 6 weeks ]
  • interleukins [ Time Frame: 6 weeks ]
  • Serum C-reactive protein [ Time Frame: 6 weeks ]
  • Bone formation markers [ Time Frame: 6 weeks ]

Other Outcome Measures:
  • Intestinal transporters polymorphisms, [ Time Frame: Baseline ]

Enrollment: 40
Study Start Date: March 2014
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: b-cryptoxanthin plus phytosterols
Fruit and milk based beverage enriched with b-cryptoxanthin and phytosterols
Dietary Supplement: b-cryptoxanthin plus phytosterols
Placebo Comparator: control
Fruit and milk based beverage not enriched
Dietary Supplement: b-cryptoxanthin plus phytosterols

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Post-menopausal women; mild hypercholesterolemia

Exclusion Criteria:

  • Use of cholesterol lowering drugs, hormonal therapy, vitamin and herbs supplements use
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02065024

Locations
Spain
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda (Madrid), Madrid, Spain, 28222
Sponsors and Collaborators
Puerta de Hierro University Hospital
  More Information

Responsible Party: Fernando Granado Lorencio, dr Fernando Granado Lorencio, Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier: NCT02065024     History of Changes
Other Study ID Numbers: AGL2012-39503-C02-02
Study First Received: February 7, 2014
Last Updated: March 28, 2016

Keywords provided by Fernando Granado Lorencio, Puerta de Hierro University Hospital:
b-cryptoxanthin
plant sterols
serum Cholesterol
bone turnover markers

Additional relevant MeSH terms:
Osteoporosis
Hypercholesterolemia
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 21, 2017