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Inofolic NRT and the Metabolic Syndrome

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01400724
Enrollment
80
Registered
2011-07-22
Start date
2011-06-30
Completion date
2012-10-31
Last updated
2013-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome, Postmenopausal Disorder

Keywords

menopause, metabolic syndrome, myo-inositol, insulin resistance, cocoa polyphenols, isoflavones

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

Interventions

DIETARY_SUPPLEMENTInofolic NRT

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

Sponsors

University of Messina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
percentage reduction of women with metabolic syndromeat baseline and after 6 months.evaluation of metabolic syndrome criteria according with ATP III 2001

Secondary

MeasureTime frameDescription
reduction of insulin resistanceat baseline and after 6 monthsevaluation of HOMA-IR
Improvement of lipid profileat baseline and after 6 monthsreduction of serum triglycerides and increase of HDL-cholesterol
variation in serum concentration of adiponectin, visfatin and resistinat baseline and after 6 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026