Inofolic NRT and the Metabolic Syndrome

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Postmenopausal Disorder
• Interventions: Dietary Supplement: Inofolic NRT

• Registration Number: NCT01400724
• Lead Sponsor: University of Messina

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.

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

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-14
• Study First Submitted QC: 2011-07-21
• Study First Posted: 2011-07-22
• Primary Completion: 2012-07
• Study Completion: 2012-10
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-15
• Last Update Posted: 2013-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inofolic NRT	Inofolic NRT	-

Primary Outcome Measures

Name	Time	Method
percentage reduction of women with metabolic syndrome	at baseline and after 6 months.	evaluation of metabolic syndrome criteria according with ATP III 2001

Secondary Outcome Measures

Name	Time	Method
Improvement of lipid profile	at baseline and after 6 months	reduction of serum triglycerides and increase of HDL-cholesterol
reduction of insulin resistance	at baseline and after 6 months	evaluation of HOMA-IR
variation in serum concentration of adiponectin, visfatin and resistin	at baseline and after 6 months

Trial Locations

Locations (1)

University Hospital; 🇮🇹 Messina, Italy