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Inofolic NRT and the Metabolic Syndrome

NCT01400724 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2013-07-16

No results posted yet for this study

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). 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.

Conditions

  • Metabolic Syndrome
  • Postmenopausal Disorder

Interventions

DIETARY_SUPPLEMENT

Inofolic NRT

Dietary supplement: myo-inositol 2000 mg plus cocoa polyphenols 30 mg and plus isoflavones 80 mg

Sponsors & Collaborators

  • University of Messina

    lead OTHER

Principal Investigators

  • Rosario D'Anna, professor · University of Messina

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-07-31
Completion
2012-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01400724 on ClinicalTrials.gov