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

This study is ongoing, but not recruiting participants.
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 3, 2014
Last verified: February 2014
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Puerta de Hierro University Hospital:

Primary Outcome Measures:
  • serum response of B-cryptoxanthin [ Time Frame: 6 weeks of intervention ] [ Designated as safety issue: No ]
  • Serum response of phytosterols [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum lipid profile [ Time Frame: 6 weks of intervention ] [ Designated as safety issue: No ]
  • bone resorption markers [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • interleukins [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Serum C-reactive protein [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Bone formation markers [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Intestinal transporters polymorphisms, [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2014
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (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

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders 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

No publications provided

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 3, 2014
Health Authority: Spain: Ministry of Health

Keywords provided by 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
Cryptoxanthin
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 29, 2014