Inofolic NRT and the Metabolic Syndrome

NCT01400724 | Completed

• 2 other identifiers: INOFOLIC-NRTNRT-LO.LI
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

menopause; metabolic syndrome; myo-inositol; insulin resistance; cocoa polyphenols; isoflavones

Outcome Measures

Primary Outcomes (1)

• percentage reduction of women with metabolic syndrome

  evaluation of metabolic syndrome criteria according with ATP III 2001

  at baseline and after 6 months.

Secondary Outcomes (3)

• reduction of insulin resistance

  at baseline and after 6 months

• Improvement of lipid profile

  at baseline and after 6 months

• variation in serum concentration of adiponectin, visfatin and resistin

  at baseline and after 6 months

Study Arms (1)

Inofolic NRT

EXPERIMENTAL

Dietary Supplement: Inofolic NRT

Interventions

Inofolic NRT DIETARY_SUPPLEMENT

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

Inofolic NRT

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Messina: lead

Study Sites (1)

University Hospital

Messina, 98100, Italy

Location

Related Publications (1)

• 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.

  PMID: 25254044 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Rosario D'Anna, professor

  University of Messina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: July 22, 2011
• Study Start: June 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2012
• Last Updated: July 16, 2013

Record last verified: 2013-07

Locations

IT (1)