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

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ClinicalTrials.gov Identifier: NCT02065024
Recruitment Status : Completed
First Posted : February 17, 2014
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Fernando Granado Lorencio, Puerta de Hierro University Hospital

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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Osteoporosis Dietary Supplement: b-cryptoxanthin plus phytosterols Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (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
Study Start Date : March 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
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



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

Secondary Outcome Measures :
  1. Serum lipid profile [ Time Frame: 6 weks of intervention ]
  2. bone resorption markers [ Time Frame: 6 weeks ]
  3. interleukins [ Time Frame: 6 weeks ]
  4. Serum C-reactive protein [ Time Frame: 6 weeks ]
  5. Bone formation markers [ Time Frame: 6 weeks ]
  6. Sterols faecal levels [ Time Frame: 6 weeks ]
  7. Erythrocytes for eryptosis evaluation [ Time Frame: 6 weeks ]

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


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065024


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

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
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018

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
Metabolic Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Beta-Cryptoxanthin
Provitamins
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs