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Inofolic NRT and the Metabolic Syndrome

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Contents

clinicaltrials.gov/study/NCT01400724
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT014007240
Health Conditions in Trial
Metabolic syndrome
Metabolic syndrome
0
Trial Recruitment Size
800
Trial Sponsor
University of Messina
University of Messina
0
Clinical Trial Start Date
2011
0
Primary Completion Date
2012
0
Study Completion Date
2012
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Supportive Care0
Intervention Type
Dietary Supplement0
Interventional Trial Phase
Not Applicable0
Participating Facility
‌
University Hospital
0
Official Name
Effects of Inofolic NRT on Post-menopausal Women Affected by the Metabolic Syndrome0
Last Updated
July 16, 2013
0
Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Single0
Masked Party
Participant0

Other attributes

Intervention Treatment
Inofolic NRT0
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.

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