Inofolic NRT and the Metabolic Syndrome

July 15, 2013 updated by: Rosario D'anna, University of Messina

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. waist circumference > 88 cm
  2. Triglycerides > 150 mg/dl
  3. HDL-cholesterol < 50 mg/dl
  4. Fast glycemia > 110 mg/dl
  5. 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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Messina, Italy, 98100
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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:

  1. waist circumference > 88 cm
  2. Triglycerides > 150 mg/dl
  3. HDL-cholesterol < 50 mg/dl
  4. Fast glycemia > 110 mg/dl
  5. 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Inofolic NRT
Dietary supplement: Inofolic NRT
Dietary supplement: myo-inositol 2000 mg plus cocoa polyphenols 30 mg and plus isoflavones 80 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at baseline and after 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction of insulin resistance
Time Frame: at baseline and after 6 months
evaluation of HOMA-IR
at baseline and after 6 months
Improvement of lipid profile
Time Frame: at baseline and after 6 months
reduction of serum triglycerides and increase of HDL-cholesterol
at baseline and after 6 months
variation in serum concentration of adiponectin, visfatin and resistin
Time Frame: at baseline and after 6 months
at baseline and after 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Messina

Investigators

  • Principal Investigator: Rosario D'Anna, professor, University of Messina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

July 14, 2011

First Submitted That Met QC Criteria

July 21, 2011

First Posted (ESTIMATE)

July 22, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

July 16, 2013

Last Update Submitted That Met QC Criteria

July 15, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INOFOLIC-NRT
  • NRT-LO.LI (OTHER_GRANT: LO.LI Pharma)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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