NCT01074723

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 10, 2014

Status Verified

February 1, 2014

Enrollment Period

5 months

First QC Date

February 23, 2010

Last Update Submit

February 7, 2014

Conditions

Postmenopausal Disorder

Keywords

b-cryptoxanthincholesterolbone markersOsteoporosiscardiovascular riskpost-menopausal women

Outcome Measures

Primary Outcomes (1)

  • Serum b-cryptoxanthin

    4 weeks

Secondary Outcomes (3)

  • Serum Cardiovascular risk markers

    4 weeks

  • Serum bone markers

    4 weeks

  • Genetic variability (polymorphisms)and DNA oxidative damage

    4 weeks

Study Arms (3)

b-cryptoxanthin

EXPERIMENTAL
Dietary Supplement: b-cryptoxanthin and phytosterols

phytosterols

EXPERIMENTAL
Dietary Supplement: b-cryptoxanthin and phytosterols

b-cryptoxanthin plus phytosterols

EXPERIMENTAL
Dietary Supplement: b-cryptoxanthin and phytosterols

Interventions

b-cryptoxanthin and phytosterolsDIETARY_SUPPLEMENT

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.

Also known as: carotenoids, plant sterols
b-cryptoxanthinb-cryptoxanthin plus phytosterolsphytosterols

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Post-menopausal women, 45-60 years old

You may not qualify if:

  • 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,...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Puerta de Hierro University Hospital

Madrid, Madrid, 28222, Spain

Location

Related Publications (2)

  • Granado-Lorencio F, de Las Heras L, Millan CS, Garcia-Lopez FJ, Blanco-Navarro I, Perez-Sacristan B, Dominguez G. beta-Cryptoxanthin modulates the response to phytosterols in post-menopausal women carrying NPC1L1 L272L and ABCG8 A632 V polymorphisms: an exploratory study. Genes Nutr. 2014 Sep;9(5):428. doi: 10.1007/s12263-014-0428-0. Epub 2014 Aug 28.

    PMID: 25163590DERIVED

  • Granado-Lorencio F, Lagarda MJ, Garcia-Lopez FJ, Sanchez-Siles LM, Blanco-Navarro I, Alegria A, Perez-Sacristan B, Garcia-Llatas G, Donoso-Navarro E, Silvestre-Mardomingo RA, Barbera R. Effect of beta-cryptoxanthin plus phytosterols on cardiovascular risk and bone turnover markers in post-menopausal women: a randomized crossover trial. Nutr Metab Cardiovasc Dis. 2014 Oct;24(10):1090-6. doi: 10.1016/j.numecd.2014.04.013. Epub 2014 May 6.

    PMID: 24909799DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

PhytosterolsCarotenoids

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SterolsCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsMembrane LipidsLipidsPhytochemicalsBiological FactorsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, Biological

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Fernando Granado lorencio

Study Record Dates

First Submitted

February 23, 2010

First Posted

February 24, 2010

Study Start

February 1, 2010

Primary Completion

July 1, 2010

Study Completion

December 1, 2012

Last Updated

February 10, 2014

Record last verified: 2014-02

Locations

ES(1)