A randomised trial to determine whether the the combination of inositol and alpha lipoic acid as supplementation of low calories ... View Homepage


Ontology type: schema:MedicalStudy     


Clinical Trial Info

YEARS

2011-2012

ABSTRACT

Background and study aims Metabolic syndrome is the medical term for a combination of diabetes, high blood pressure and obesity. After the menopause women are often affected by metabolic syndrome and are also at a higher risk of breast cancer. The aim of this study is to determine whether an inositol and alpha lipoic acid supplement and a low-calorie diet can improve metabolic syndrome symptoms in post-menopausal women. Who can participate? Post-menopausal women with metabolic syndrome who are at risk of breast cancer (e.g., family history of breast or ovarian cancer) What does the study involve? All participants are asked to follow a low-calorie diet and are randomly allocated to take either inositol and alpha lipoic acid or a placebo (dummy) supplement daily for six months. All participants provide blood samples to test their blood levels of sugar, insulin, cholesterol and triglycerides (fats). Height, weight and waist and hip circumference are also measured. After six months more blood samples are taken in order to assess changes in insulin and lipid (fat) levels. What are the possible benefits and risks of participating? Participants may benefit from a reduction in triglycerides, cholesterol, sugar and insulin levels. Where is the study run from? National Cancer Institute of Naples – Fondazione G. Pascale (Italy) When is the study starting and how long is it expected to run for? October 2011 to September 2012 Who is funding the study? National Cancer Institute of Naples and Pharma DANCAN s.r.l. (Italy) Who is the main contact? Dr Immacolata Capasso icapasso@tiscali.it More... »

URL

http://www.isrctn.com/ISRCTN74096908

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