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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01400724
Other study ID # INOFOLIC-NRT
Secondary ID NRT-LO.LI
Status Completed
Phase N/A
First received July 14, 2011
Last updated July 15, 2013
Start date June 2011
Est. completion date October 2012

Study information

Verified date July 2013
Source University of Messina
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date October 2012
Est. primary completion date July 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care


Intervention

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

Locations

Country Name City State
Italy University Hospital Messina

Sponsors (1)

Lead Sponsor Collaborator
University of Messina

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary percentage reduction of women with metabolic syndrome evaluation of metabolic syndrome criteria according with ATP III 2001 at baseline and after 6 months. Yes
Secondary reduction of insulin resistance evaluation of HOMA-IR at baseline and after 6 months Yes
Secondary Improvement of lipid profile reduction of serum triglycerides and increase of HDL-cholesterol at baseline and after 6 months Yes
Secondary variation in serum concentration of adiponectin, visfatin and resistin at baseline and after 6 months Yes
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