INOSIDEX study: to determine whether the combination of inositol and alpha lipoic acid as supplementation of low calories diet can adjust metabolic syndrome parameters in post-menopausal women
| ISRCTN | ISRCTN74096908 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74096908 |
| Secondary identifying numbers | 02 |
- Submission date
- 04/10/2012
- Registration date
- 04/01/2013
- Last edited
- 21/10/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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
Contact information
Scientific
National Cancer Insitute of Naples
Fondazione G. Pascale
Via Cappella dei Cangiani
Naples
80131
Italy
| Phone | +39 (0)81 590 3381 |
|---|---|
| icapasso@tiscali.it |
Study information
| Study design | Prospective randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study 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(s) | National Cancer Institute of Naples, Scientific and Ethics Committee, 15/09/2011 |
| 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 |
| Primary outcome measure | 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 study start date | 16/10/2011 |
| Overall study end date | 16/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 155 |
| 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 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
Study participating centre
80131
Italy
Sponsor information
Industry
c/o Danilo Arnone
Via B. Cavallino, 74
Naples
80128
Italy
| Phone | +39 (0)334 184 3758 |
|---|---|
| d.arnone@pharmadancan.it |
Funders
Funder type
Government
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/08/2013 | Yes | No |
Editorial Notes
21/10/2016: Plain English summary added.
