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Completed

NCT Number: NCT01074723

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

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.

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Key information

Conditions

Postmenopausal Disorder Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Puerta de Hierro University Hospital

Madrid, 28222, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,...)

Treatment and study plan

b-cryptoxanthin and phytosterols

Dietary 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.

Other names: carotenoids, plant sterols

Primary outcomes

  1. Serum b-cryptoxanthin

    Time frame: 4 weeks

Secondary outcomes

  1. Serum Cardiovascular risk markers

    Time frame: 4 weeks

  2. Serum bone markers

    Time frame: 4 weeks

  3. Genetic variability (polymorphisms)and DNA oxidative damage

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Puerta de Hierro University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2012
First posted
Feb 24, 2010
Registry last updated
Feb 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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