Clinical trial NCT01400724: Inofolic NRT and the Metabolic Syndrome
Official title: Effects of Inofolic NRT on Post-menopausal Women Affected by the Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Postmenopausal Disorder
Keywords: menopause
metabolic syndrome
myo-inositol
insulin resistance
cocoa polyphenols
isoflavones
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2011-07-22
Enrollment: 80
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility 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

Primary outcomes:
measure: percentage reduction of women with metabolic syndrome
timeFrame: at baseline and after 6 months.
Secondary outcomes:
measure: reduction of insulin resistance
timeFrame: at baseline and after 6 months
measure: Improvement of lipid profile
timeFrame: at baseline and after 6 months
measure: variation in serum concentration of adiponectin, visfatin and resistin
timeFrame: at baseline and after 6 months
Other outcomes:
Locations:
city: Messina
country: Italy
facility: University Hospital
Study officials:
affiliation: University of Messina
name: Rosario D'Anna, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: D'Anna R, Santamaria A, Cannata ML, Interdonato ML, Giorgianni GM, Granese R, Corrado F, Bitto A. Effects of a new flavonoid and Myo-inositol supplement on some biomarkers of cardiovascular risk in postmenopausal women: a randomized trial. Int J Endocrinol. 2014;2014:653561. doi: 10.1155/2014/653561. Epub 2014 Aug 31.