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B-cryptoxanthin and Phytosterols on Bone Remodeling and Cardiovascular Risk Factors

Sponsor
Puerta de Hierro University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01074723
Collaborator
(none)
36
Enrollment
1
Location
3
Arms
34
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

We, the investigators, aim to study, in vitro and in vivo, the bioavailability of added b-cryptoxanthin and phytosterols and evaluate in vivo its effect on biochemical markers of bone remodelling and cardiovascular risk. Specifically, we will 1) assess the stability in the food and the bioavailability of b-cryptoxanthin in the presence of phytosterols (absorption modifiers) by using a complementary approach; in vitro and in vivo studies; and 2) we will study in post-menopausal women (target group) the biological effect (bioefficacy) associated with the regular consumption of modified milk-based fruit beverages (containing b-cryptoxanthin and phytosterols) by assessing changes in biochemical markers of bone turnover and cardiovascular risk.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: b-cryptoxanthin and phytosterols
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Bioavailability of Added B-cryptoxanthin and Phytosterols; In Vitro and in Vivo Interactions and Effect on Bone Remodelling and Cardiovascular Risk Markers
Study Start Date :
Feb 1, 2010
Actual Primary Completion Date :
Jul 1, 2010
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: b-cryptoxanthin

Dietary Supplement: b-cryptoxanthin and phytosterols
Fruit juices containing b-cryptoxanthin (ca. 1 mg), phytosterols (ca 1.7g) or both will be consumed for 4 weeks with a 4-week washout in between.
Other Names:
  • carotenoids, plant sterols

    		•
    Experimental: phytosterols

    Dietary Supplement: b-cryptoxanthin and phytosterols
    Fruit juices containing b-cryptoxanthin (ca. 1 mg), phytosterols (ca 1.7g) or both will be consumed for 4 weeks with a 4-week washout in between.
    Other Names:
  • carotenoids, plant sterols

    		•
    Experimental: b-cryptoxanthin plus phytosterols

    Dietary Supplement: b-cryptoxanthin and phytosterols
    Fruit juices containing b-cryptoxanthin (ca. 1 mg), phytosterols (ca 1.7g) or both will be consumed for 4 weeks with a 4-week washout in between.
    Other Names:
  • carotenoids, plant sterols

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Serum b-cryptoxanthin [4 weeks]

    Secondary Outcome Measures

    1. Serum Cardiovascular risk markers [4 weeks]

    2. Serum bone markers [4 weeks]

    3. Genetic variability (polymorphisms)and DNA oxidative damage [4 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Post-menopausal women, 45-60 years old
    Exclusion Criteria:

    • Dieting

    • Food allergy (to any components provided)

    • Hormone replacement therapy

    • Cholesterol lowering drugs, antiresorptive or anabolic bone drugs

    • Calcium and vitamin D supplements

    • Soybean products

    • Vitamin-mineral supplements

    • Fibre supplements

    • Commercially available enriched foods (i.e. w-3, phytosterols,carotenoids,...)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Puerta de Hierro University Hospital Madrid Spain 28222

    Sponsors and Collaborators

    • Puerta de Hierro University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fernando Granado Lorencio, Dr. Fernando Granado lorencio, Puerta de Hierro University Hospital
    ClinicalTrials.gov Identifier:
    NCT01074723
    Other Study ID Numbers:
    • AGL-2008-02591-C02-02
    First Posted:
    Feb 24, 2010
    Last Update Posted:
    Feb 10, 2014
    Last Verified:
    Feb 1, 2014
    Keywords provided by Fernando Granado Lorencio, Dr. Fernando Granado lorencio, Puerta de Hierro University Hospital
    b-cryptoxanthin
    cholesterol
    bone markers
    Osteoporosis
    cardiovascular risk
    post-menopausal women
    Additional relevant MeSH terms:
    Carotenoids

    Study Results

    No Results Posted as of Feb 10, 2014