Inofolic NRT and the Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

Effects of Inofolic NRT on Post-menopausal Women Affected by the Metabolic Syndrome

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Postmenopausal Disorder
• Syndrome

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