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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Postmenopausal Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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b-cryptoxanthin

Group Type EXPERIMENTAL

b-cryptoxanthin and phytosterols

Intervention Type 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.

phytosterols

Group Type EXPERIMENTAL

b-cryptoxanthin and phytosterols

Intervention Type 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.

b-cryptoxanthin plus phytosterols

Group Type EXPERIMENTAL

b-cryptoxanthin and phytosterols

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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carotenoids, plant sterols

Eligibility Criteria

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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,...)

Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes