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

July 14, 2011
July 15, 2013
June 2011
July 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01400724 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
  • reduction of hot flushes [ Time Frame: at baseline and after 6 months ] [ Designated as safety issue: No ]
    reduction in frequency and severity of hot flushes
Not Provided
Not Provided
 
Inofolic NRT and the Metabolic Syndrome
Effects of Inofolic NRT on Post-menopausal Women Affected by the Metabolic Syndrome

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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
  • Metabolic Syndrome
  • Postmenopausal Disorder
Dietary Supplement: Inofolic NRT
Dietary supplement: myo-inositol 2000 mg plus cocoa polyphenols 30 mg and plus isoflavones 80 mg
Experimental: Inofolic NRT
Intervention: Dietary Supplement: Inofolic NRT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
October 2012
July 2012   (final data collection date for primary outcome measure)

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
Female
50 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01400724
INOFOLIC-NRT, NRT-LO.LI
No
Rosario D'anna, University of Messina
University of Messina
Not Provided
Principal Investigator: Rosario D'Anna, professor University of Messina
University of Messina
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP