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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01074723
First Posted: February 24, 2010
Last Update Posted: February 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fernando Granado Lorencio, Puerta de Hierro University Hospital
  Purpose
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 Intervention Phase
Postmenopausal Disorder Dietary Supplement: b-cryptoxanthin and phytosterols Phase 1

Study Type: Interventional
Study Design: 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

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

Primary Outcome Measures:
  • Serum b-cryptoxanthin [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Serum Cardiovascular risk markers [ Time Frame: 4 weeks ]
  • Serum bone markers [ Time Frame: 4 weeks ]
  • Genetic variability (polymorphisms)and DNA oxidative damage [ Time Frame: 4 weeks ]

Enrollment: 36
Study Start Date: February 2010
Study Completion Date: December 2012
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: carotenoids, plant sterols

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
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): NCT01074723


Locations
Spain
Puerta de Hierro University Hospital
Madrid, Spain, 28222
Sponsors and Collaborators
Puerta de Hierro University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fernando Granado Lorencio, Dr. Fernando Granado lorencio, Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier: NCT01074723     History of Changes
Other Study ID Numbers: AGL-2008-02591-C02-02
First Submitted: February 23, 2010
First Posted: February 24, 2010
Last Update Posted: February 10, 2014
Last Verified: February 2014

Keywords provided by Fernando Granado Lorencio, Puerta de Hierro University Hospital:
b-cryptoxanthin
cholesterol
bone markers
Osteoporosis
cardiovascular risk
post-menopausal women