Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fernando Granado Lorencio, Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier:
NCT01074723
First received: February 23, 2010
Last updated: February 7, 2014
Last verified: February 2014
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Serum b-cryptoxanthin [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum Cardiovascular risk markers [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Serum bone markers [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Genetic variability (polymorphisms)and DNA oxidative damage [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   45 Years to 60 Years
Genders 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
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: NCT01074723

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

No publications provided by Puerta de Hierro University Hospital

Additional 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
Study First Received: February 23, 2010
Last Updated: February 7, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

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

Additional relevant MeSH terms:
Cryptoxanthin
Anticarcinogenic Agents
Antineoplastic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014