Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: July 15, 2013
Last verified: July 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 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
Syndrome
Disease
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014