Inofolic NRT and the Metabolic Syndrome

University of Messina

Status: Completed

Conditions: Postmenopausal Disorder; Metabolic Syndrome

Treatments: Dietary Supplement: Inofolic NRT

Study type: Interventional

Funder types: Other

Identifiers

NCT01400724

NRT-LO.LI (Other Grant/Funding Number)

INOFOLIC-NRT

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 patients

Sex: Female

Ages: 50 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 1 patient group

Inofolic NRT

Experimental group

Treatment:

Dietary Supplement: Inofolic NRT