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

Majadahonda Iron Gate University

Status and phase: Completed; Phase 1

Conditions: Postmenopausal Disorder

Treatments: Dietary Supplement: b-cryptoxanthin and phytosterols

Study type: Interventional

Funder types: Other

Identifiers

NCT01074723

AGL-2008-02591-C02-02

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: Accepts Healthy Volunteers

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,...)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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36 participants in 3 patient groups

b-cryptoxanthin

Experimental group

Treatment:

Dietary Supplement: b-cryptoxanthin and phytosterols

phytosterols

Experimental group

Treatment:

Dietary Supplement: b-cryptoxanthin and phytosterols

b-cryptoxanthin plus phytosterols

Experimental group

Treatment:

Dietary Supplement: b-cryptoxanthin and phytosterols