NCT03469518

Brief Summary

Regular consumption of a beverage containing β-cryptoxanthin (β-Cx) and plant sterols (PS) has been shown to exert a synergic effect in reducing some markers of cardiovascular risk and bone-remodeling (formation and resorption). The present project aims to:

  • Evaluate (by in vivo and in vitro studies) the bioavailability of added β-Cx, PS and galactooligosaccharides (GOS) and its stability in the beverage employed in the proposed study.
  • Study the biological effect (bioefficacy) associated with the regular consumption of modified milk-based fruit beverages containing β-Cx, PS and GOS in post-menopausal women (target group) by assessing changes in inflammation, cardiovascular and bone turnover biochemical markers.
  • Characterize genetic variability (polymorphisms), genetic expression and DNA oxidative damage in the target group as determinants of bioavailability and biological effects of β-Cx, PS and GOS.
  • Evaluate the potential prebiotic effect associated to regular consumption of a beverage supplemented with β-Cx, PS and GOS: including "in vitro" studies and characterization of subjects' microbiota and possible microbiota changes associated to the beverage consumption.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

6 months

First QC Date

February 19, 2018

Last Update Submit

May 8, 2019

Conditions

HypercholesterolemiaOsteoporosisPostmenopausal Disorder

Keywords

beta-cryptoxanthincholesterolGalactooligosaccharidesPlant SterolsCardiovascular riskBone Turnover markersIntestinal Inflammatory markersMicrobiota

Outcome Measures

Primary Outcomes (2)

  • Serum levels of β-Cx

    6 weeks

  • Serum levels of PS

    6 weeks

Secondary Outcomes (8)

  • Serum lipid profile

    6 weeks

  • C reactive protein, ferritin, calprotectin, alpha-1-antitrypsin, alpha-1-acid

    6 weeks

  • Beta C-terminal telopeptide (beta-CrossLaps/betaCTx), osteoprotegerin, Parathyroid hormone (PTH), calcium, phosphorus, Alkaline phosphatase

    6 weeks

  • Sterol fecal levels

    6 weeks

  • β-cryptoxanthin fecal levels

    6 weeks

  • +3 more secondary outcomes

Study Arms (2)

β-Cx plus PS

SHAM COMPARATOR

Fruit and milk based beverage enriched with beta-cryptoxanthin and plant sterols

Dietary Supplement: β-Cx plus PS

β-Cx plus PS plus GOS

ACTIVE COMPARATOR

Fruit and milk bases beverage enriched with beta-criptoxanthin, plant sterols and galactooligosaccharides

Dietary Supplement: β-Cx plus PS plus GOS

Interventions

β-Cx plus PS plus GOSDIETARY_SUPPLEMENT
β-Cx plus PS plus GOS
β-Cx plus PSDIETARY_SUPPLEMENT
β-Cx plus PS

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age (45-65 years), BMI\<35 Kg/m2, amenorrhea over 12 months, non-dieting and non-intake of vitamin D, calcium and ω-3 fatty acids and PS or vitamin-enriched foods or supplements or other dietary bioactive components.

You may not qualify if:

  • Use of vitamins, hormone replacement therapy, fibrates, statins and a weight losing diet, as well as acute inflammation, chronic medication and infection or intercurrent illness capable of affecting the bioavailability or status of the compounds of interest.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypercholesterolemiaOsteoporosis

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal Diseases

Study Officials

  • Fernando Granado Lorencio, PhD

    Hospital Universitario Puerta de Hierro-Majadahonda

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Crossover Assigment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator. Chief Assistance.

Study Record Dates

First Submitted

February 19, 2018

First Posted

March 19, 2018

Study Start

January 1, 2017

Primary Completion

July 1, 2017

Study Completion

December 1, 2019

Last Updated

May 9, 2019

Record last verified: 2019-05