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NCT Number: NCT01400724

Inofolic NRT and the Metabolic Syndrome

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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Postmenopausal Disorder

Age range

50 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Messina, 98100, Italy

About this study

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:

  • waist circumference > 88 cm
  • Triglycerides > 150 mg/dl
  • HDL-cholesterol < 50 mg/dl
  • Fast glycemia > 110 mg/dl
  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

  • waist circumference > 88 cm
  • Triglycerides > 150 mg/dl
  • HDL-cholesterol < 50 mg/dl
  • Fast glycemia > 110 mg/dl
  • Systolic blood pressure > 135 mmHg. diastolic > 85 mmHg -

Exclusion criteria

  • post-menopausal women with less than 12 months from the last menstruation
  • less than 3 criteria according with ATP III
  • TSH > 3.5
  • in treatment with drugs lowering glycemia or cholesterol
  • allergy to cocoa

Treatment and study plan

Inofolic NRT

Dietary Supplement

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

Primary outcomes

  1. percentage reduction of women with metabolic syndrome

    Time frame: at baseline and after 6 months.

    evaluation of metabolic syndrome criteria according with ATP III 2001

Secondary outcomes

  1. reduction of insulin resistance

    Time frame: at baseline and after 6 months

    evaluation of HOMA-IR

  2. Improvement of lipid profile

    Time frame: at baseline and after 6 months

    reduction of serum triglycerides and increase of HDL-cholesterol

  3. variation in serum concentration of adiponectin, visfatin and resistin

    Time frame: at baseline and after 6 months

Sponsors and collaborators

Lead sponsor

University of Messina

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 22, 2011
Registry last updated
Jul 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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