Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/10/2012
Date assigned
04/01/2013
Last edited
21/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Immacolata Capasso

ORCID ID

Contact details

National Cancer Insitute of Naples
Fondazione G. Pascale
Via Cappella dei Cangiani
Naples
80131
Italy
+39 (0)81 590 3381
icapasso@tiscali.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

02

Study information

Scientific title

A randomised trial to determine whether the the combination of inositol and alpha lipoic acid as supplementation of low calories diet can adjust metabolic syndrome parameters in post-menopausal women

Acronym

INOSIDEX

Study hypothesis

It is hypothesised that the inositol improves insulin sensitivity since it works as a second messenger that may achieve an insulin like effect on metabolic enzymes. Inositol combined with alpha lipoic acid can be used as a dietary supplement in insulin resistant patients in order to increase their insulin sensitiveness. Inositol is a vitamin B complex constituent that rules as second messenger in insulin pathway. Alpha lipoic acid is a fatty acid playing a leading role in the cellular energetic metabolism exerting antioxidant activities on free radicals, promoting glucose cellular intake, taking part in fat catabolism on Krebs cycle. Post-menopausal women are often affected by MS and show the highest incidence of breast cancer in the female population. Breast cancer is also associated with adverse outcomes in patients with metabolic syndrome phenotype.

Ethics approval

National Cancer Institute of Naples, Scientific and Ethics Committee, 15/09/2011

Study design

Prospective randomized controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Optimum control of insulin resistance and lipid profile in post-menopausal women

Intervention

The study has involved 155 postmenopausal women with metabolic syndrome recruited at visit for clinical-instrumental surveillance program for breast cancer prevention within National Cancer Institute of Naples.

All women were asked to follow a low calorie diet and were assigned randomly to receive daily combination of 4g of inositol and alpha lipoic acid or placebo for six months.

Blood samples and anthropometric measures were taken at baseline and at six months.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

1. Reduction of more than 20% of HOMA-IR index and of triglycerides
2. Improvement of high density lipoprotein cholesterol
3. Reduction of anthropometric features such as body mass index, waist and hip ratio
Measured at at baseline and at six months.

Secondary outcome measures

Good control of metabolic syndrome helping diet results with insulin sensitizing supplements

Overall trial start date

16/10/2011

Overall trial end date

16/09/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Post-menopausal women affected by metabolic syndrome at any age participating to our clinical-instrumental program of surveillance for breast cancer prevention
2. Willing to be assigned to any of the study intervention groups

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

155

Participant exclusion criteria

1. Women taking oral hypoglycemic drugs or insulin
2. Women taking statins

Recruitment start date

16/10/2011

Recruitment end date

16/09/2012

Locations

Countries of recruitment

Italy

Trial participating centre

National Cancer Insitute of Naples
Naples
80131
Italy

Sponsor information

Organisation

Pharma Dancan s.r.l. (Italy)

Sponsor details

c/o Danilo Arnone
Via B. Cavallino
74
Naples
80128
Italy
+39 (0)334 184 3758
d.arnone@pharmadancan.it

Sponsor type

Industry

Website

Funders

Funder type

Government

Funder name

National Cancer Institute of Naples (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Pharma Dancan s.r.l. (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23981814

Publication citations

  1. Results

    Capasso I, Esposito E, Maurea N, Montella M, Crispo A, De Laurentiis M, D'Aiuto M, Frasci G, Botti G, Grimaldi M, Cavalcanti E, Esposito G, Fucito A, Brillante G, D'Aiuto G, Ciliberto G, Combination of inositol and alpha lipoic acid in metabolic syndrome-affected women: a randomized placebo-controlled trial., Trials, 2013, 14, 273, doi: 10.1186/1745-6215-14-273.

Additional files

Editorial Notes

21/10/2016: Plain English summary added.