Metabolic SyndromeNCT01400724
Inofolic NRT and the Metabolic Syndrome
A study testing Inofolic NRT in people with Metabolic Syndrome and Postmenopausal Disorder, run by University of Messina at 1 site in Italy.
Trial summary
A prospective, randomized, controlled, open-label study will be carried out on 80 post-menopausal women affected by the metabolic syndrome (criteria are described in NIH ATP III). Read more about this study
- Who is it for?
- Ages 50 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Postmenopausal Disorder
- What is being tested?
- Inofolic NRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2011to Oct 2012
- Phase
- Interventional
- 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 50 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- post-menopausal women with less than 12 months from the last menstruation
- less than 3 criteria according with ATP III
- TSH > 3.5
- in treatment with drugs lowering glycemia or cholesterol
- allergy to cocoa
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Inofolic NRT on Post-menopausal Women Affected by the Metabolic Syndrome
A prospective, randomized, controlled, open-label study will be carried out on 80 post-menopausal women affected by the metabolic syndrome (criteria are described in NIH ATP III). After a written informed consent, women will be randomly treated for 6 months with hypocaloric diet (control group) or with diet and a supplementation of myo-inositol 2000 mg plus cocoa polyphenols 30 mg and plus isoflavones 80 mg. will be given randomly Eighty post-menopausal women, affected by metabolic syndrome will be randomized into two groups: 40 treated with myo-inositol 2 g twice per day and forty treated with placebo for six months. The investigators hypothesize that the administration of myo-inositol would improve the insulin-receptor activity in these women, reducing insulin resistance.
Read the detailed description
Inclusion Criteria: post-menopausal women (12 months after last menstruation) affected by metabolic syndrome according to ATP III, 2001.
At least 3 of following 5 criteria must be present:
- waist circumference > 88 cm
- Triglycerides > 150 mg/dl
- HDL-cholesterol < 50 mg/dl
- Fast glycemia > 110 mg/dl
- Systolic blood pressure > 135 mmHg. diastolic > 85 mmHg -
Exclusion Criteria:1) post-menopausal women with less than 12 months from the last menstruation 2) less than 3 criteria according with ATP III 3) TSH > 3.5 4) in treatment with drugs lowering glycemia or cholesterol 5) allergy to cocoa
- Conditions
- Metabolic Syndrome, Postmenopausal Disorder
- Being tested
- Inofolic NRT
- Keywords
- menopause, metabolic syndrome, myo-inositol, insulin resistance, cocoa polyphenols, isoflavones
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inofolic NRTDietary supplement
Dietary supplement: myo-inositol 2000 mg plus cocoa polyphenols 30 mg and plus isoflavones 80 mg
| Study group | Role | What they receive |
|---|---|---|
| Inofolic NRT | Experimental | Not described Receives: Dietary Supplement: Inofolic NRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage reduction of women with metabolic syndrome
evaluation of metabolic syndrome criteria according with ATP III 2001
Measured: at baseline and after 6 months.
Secondary outcomes (3)
reduction of insulin resistance
evaluation of HOMA-IR
Measured: at baseline and after 6 months
Improvement of lipid profile
reduction of serum triglycerides and increase of HDL-cholesterol
Measured: at baseline and after 6 months
variation in serum concentration of adiponectin, visfatin and resistin
Measured: at baseline and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Messina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosario D'anna, University of Messina
- Investigators
- Rosario D'Anna, professor, Principal investigator, University of Messina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400724
- Sponsor's protocol ID
- INOFOLIC-NRT
- Other IDs
- NRT-LO.LI
- Status last verified
- Jul 2013
- First submitted
- 14 Jul 2011
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
D'Anna R, Santamaria A, Cannata ML, Interdonato ML, Giorgianni GM, Granese R, Corrado F, Bitto A. Effects of a new flavonoid and Myo-inositol supplement on some biomarkers of cardiovascular risk in postmenopausal women: a randomized trial. Int J Endocrinol. 2014;2014:653561. doi: 10.1155/2014/653561. Epub 2014 Aug 31.
PubMed 25254044
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inofolic NRT on Post-menopausal Women Affected by the Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01400724
- Acronym / sponsor ID
- INOFOLIC-NRT
- Conditions
- Metabolic Syndrome, Postmenopausal Disorder
- Keywords
- menopause, metabolic syndrome, myo-inositol, insulin resistance, cocoa polyphenols, isoflavones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of MessinaUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 22 Jul 2011 (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.
A prospective, randomized, controlled, open-label study will be carried out on 80 post-menopausal women affected by the metabolic syndrome (criteria are described in NIH ATP III). After a written informed consent, women will be randomly treated for 6 months with hypocaloric diet (control group) or with diet and a supplementation of myo-inositol 2000 mg plus cocoa polyphenols 30 mg and plus isoflavones 80 mg. will be given randomly Eighty post-menopausal women, affected by metabolic syndrome will be randomized into two groups: 40 treated with myo-inositol 2 g twice per day and forty treated with placebo for six months. The investigators hypothesize that the administration of myo-inositol would improve the insulin-receptor activity in these women, reducing insulin resistance.
Detailed description
Inclusion Criteria: post-menopausal women (12 months after last menstruation) affected by metabolic syndrome according to ATP III, 2001.
At least 3 of following 5 criteria must be present:
- waist circumference > 88 cm
- Triglycerides > 150 mg/dl
- HDL-cholesterol < 50 mg/dl
- Fast glycemia > 110 mg/dl
- Systolic blood pressure > 135 mmHg. diastolic > 85 mmHg -
Exclusion Criteria:1) post-menopausal women with less than 12 months from the last menstruation 2) less than 3 criteria according with ATP III 3) TSH > 3.5 4) in treatment with drugs lowering glycemia or cholesterol 5) allergy to cocoa
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inofolic NRT | Experimental | Dietary Supplement: Inofolic NRT |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- post-menopausal women with less than 12 months from the last menstruation
- less than 3 criteria according with ATP III
- TSH > 3.5
- in treatment with drugs lowering glycemia or cholesterol
- allergy to cocoa
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 |
|---|---|---|
| Inofolic NRTDietary supplement: myo-inositol 2000 mg plus cocoa polyphenols 30 mg and plus isoflavones 80 mg | Dietary supplement | Inofolic NRT |
Primary outcome
percentage reduction of women with metabolic syndrome
Time frame: at baseline and after 6 months.
evaluation of metabolic syndrome criteria according with ATP III 2001
3 secondary outcomes
reduction of insulin resistance
Time frame: at baseline and after 6 months
Improvement of lipid profile
Time frame: at baseline and after 6 months
variation in serum concentration of adiponectin, visfatin and resistin
Time frame: at baseline and after 6 months
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 16 Jul 2013.
- Derived from this study: PubMed 25254044D'Anna R, Santamaria A, Cannata ML, Interdonato ML, Giorgianni GM, Granese R, Corrado F, Bitto A. Effects of a new flavonoid and Myo-inositol supplement on some biomarkers of cardiovascular risk in postmenopausal women: a randomized trial. Int J Endocrinol. 2014;2014:653561. doi: 10.1155/2014/653561. Epub 2014 Aug 31.
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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.
Rosario D'Anna, professor principal investigator
University of Messina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inofolic NRT in people with Metabolic Syndrome and Postmenopausal Disorder, run by University of Messina at 1 site in Italy.
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 0 inclusion and 5 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 16 Jul 2013. 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 Italy. 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.
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?
percentage reduction of women with metabolic syndrome (time frame: at baseline and after 6 months.). 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 NCT01400724, which also lists 1 linked publication.
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 16 Jul 2013.