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

February 7, 2014 updated by: Fernando Granado Lorencio, Puerta de Hierro University Hospital

Bioavailability of Added B-cryptoxanthin and Phytosterols; In Vitro and in Vivo Interactions and Effect on Bone Remodelling and Cardiovascular Risk Markers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28222
        • Puerta de Hierro University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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,...)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum b-cryptoxanthin
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum Cardiovascular risk markers
Time Frame: 4 weeks
4 weeks
Serum bone markers
Time Frame: 4 weeks
4 weeks
Genetic variability (polymorphisms)and DNA oxidative damage
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Puerta de Hierro University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 23, 2010

First Submitted That Met QC Criteria

February 23, 2010

First Posted (Estimate)

February 24, 2010

Study Record Updates

Last Update Posted (Estimate)

February 10, 2014

Last Update Submitted That Met QC Criteria

February 7, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGL-2008-02591-C02-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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