Postmenopausal DisorderPhase 1NCT01074723
B-cryptoxanthin and Phytosterols on Bone Remodeling and Cardiovascular Risk Factors
A Phase 1 study testing b-cryptoxanthin and phytosterols in people with Postmenopausal Disorder, run by Puerta de Hierro University Hospital at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Disorder
- What is being tested?
- b-cryptoxanthin and phytosterols
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2010to Dec 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Post-menopausal women, 45-60 years old
Who cannot join
- 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
Show all 9Show fewer
- Vitamin-mineral supplements
- Fibre supplements
- Commercially available enriched foods (i.e. w-3, phytosterols,carotenoids,...)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioavailability of Added B-cryptoxanthin and Phytosterols; In Vitro and in Vivo Interactions and Effect on Bone Remodelling and Cardiovascular Risk Markers
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.
- Conditions
- Postmenopausal Disorder
- Being tested
- b-cryptoxanthin and phytosterols
- Keywords
- b-cryptoxanthin, cholesterol, bone markers, Osteoporosis, cardiovascular risk, post-menopausal women
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
b-cryptoxanthin and phytosterolsDietary supplement
Also called carotenoids, plant sterols
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.
| Study group | Role | What they receive |
|---|---|---|
| b-cryptoxanthin | Experimental | Not described Receives: Dietary Supplement: b-cryptoxanthin and phytosterols |
| phytosterols | Experimental | Not described Receives: Dietary Supplement: b-cryptoxanthin and phytosterols |
| b-cryptoxanthin plus phytosterols | Experimental | Not described Receives: Dietary Supplement: b-cryptoxanthin and phytosterols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum b-cryptoxanthin
Measured: 4 weeks
Secondary outcomes (3)
Serum Cardiovascular risk markers
Measured: 4 weeks
Serum bone markers
Measured: 4 weeks
Genetic variability (polymorphisms)and DNA oxidative damage
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2010
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Puerta de Hierro University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Granado Lorencio, Puerta de Hierro University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074723
- Sponsor's protocol ID
- AGL-2008-02591-C02-02
- Status last verified
- Feb 2014
- First submitted
- 23 Feb 2010
- Last updated
- 10 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25163590Granado-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.
PubMed 24909799
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Added B-cryptoxanthin and Phytosterols; In Vitro and in Vivo Interactions and Effect on Bone Remodelling and Cardiovascular Risk Markers
- ClinicalTrials.gov ID
- NCT01074723
- Acronym / sponsor ID
- AGL-2008-02591-C02-02
- Conditions
- Postmenopausal Disorder
- Keywords
- b-cryptoxanthin, cholesterol, bone markers, Osteoporosis, cardiovascular risk, post-menopausal women
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Puerta de Hierro University HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Post-menopausal women, 45-60 years old
Key exclusion criteria (9 listed)
- Dieting
- Food allergy (to any components provided)
- Hormone replacement therapy
- Cholesterol lowering drugs, antiresorptive or anabolic bone drugs
- Calcium and vitamin D supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| b-cryptoxanthin and phytosterolsAlso: carotenoids, plant sterolsFruit 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. | Dietary supplement | b-cryptoxanthin, b-cryptoxanthin plus phytosterols, phytosterols |
Primary outcome
Serum b-cryptoxanthin
Time frame: 4 weeks
3 secondary outcomes
Serum Cardiovascular risk markers
Time frame: 4 weeks
Serum bone markers
Time frame: 4 weeks
Genetic variability (polymorphisms)and DNA oxidative damage
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2014.
- Derived from this study: PubMed 25163590Granado-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.
- Derived from this study: PubMed 24909799Granado-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.
Related trials for Postmenopausal Disorder
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruiting
AI-Supported Mobile High-Impact and Strengthening Exercise Program in Postmenopausal Women With Low Bone Density
Osteopenia
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
Not yet recruitingPhase 4
Migraine Menopause Study
Migraine, Menopausal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing b-cryptoxanthin and phytosterols in people with Postmenopausal Disorder, run by Puerta de Hierro University Hospital at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum b-cryptoxanthin (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01074723, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2014.