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Inofolic NRT and the Metabolic Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rosario D'anna, University of Messina
ClinicalTrials.gov Identifier:
NCT01400724
First received: July 14, 2011
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Postmenopausal Disorder
 Dietary Supplement: Inofolic NRT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Effects of Inofolic NRT on Post-menopausal Women Affected by the Metabolic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Messina:

Primary Outcome Measures:
  • percentage reduction of women with metabolic syndrome [ Time Frame: at baseline and after 6 months. ] [ Designated as safety issue: Yes ]
    evaluation of metabolic syndrome criteria according with ATP III 2001


Secondary Outcome Measures:
  • reduction of insulin resistance [ Time Frame: at baseline and after 6 months ] [ Designated as safety issue: Yes ]
    evaluation of HOMA-IR

  • Improvement of lipid profile [ Time Frame: at baseline and after 6 months ] [ Designated as safety issue: Yes ]
    reduction of serum triglycerides and increase of HDL-cholesterol

  • variation in serum concentration of adiponectin, visfatin and resistin [ Time Frame: at baseline and after 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: June 2011
Study Completion Date: October 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inofolic NRT Dietary Supplement: Inofolic NRT
Dietary supplement: myo-inositol 2000 mg plus cocoa polyphenols 30 mg and plus isoflavones 80 mg

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

  Eligibility

Ages Eligible for Study:   50 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400724

Locations
Italy
University Hospital
Messina, Italy, 98100
Sponsors and Collaborators
University of Messina
Investigators
Principal Investigator: Rosario D'Anna, professor University of Messina
  More Information

No publications provided

Responsible Party: Rosario D'anna, associate professor, University of Messina
ClinicalTrials.gov Identifier: NCT01400724     History of Changes
Other Study ID Numbers: INOFOLIC-NRT, NRT-LO.LI
Study First Received: July 14, 2011
Last Updated: January 15, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by University of Messina:
menopause
metabolic syndrome
myo-inositol
 insulin resistance
cocoa polyphenols
isoflavones

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 17, 2013