A Phase 4 interventional study of Zinc and Placebos in Obesity, Childhood, Insulin Resistance and Zinc Deficiency, sponsored by Azienda Ospedaliero Universitaria Maggiore della Carita. Completed at 1 site in Italy. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by Azienda Ospedaliero Universitaria Maggiore della Carita · Phase 4, Interventional, and Treatment
Myoinositol (MI) and D-chiro inositol (DCI) are isomeric forms of inositol that were found to have insulin-like properties, acting as second messengers in the insulin intracellular pathway; both of these molecules are involved in the increasing insulin sensitivity of different tissues to improve metabolic and ovulatory functions. Myoinositol is the predominant form that can be found in nature and food.
Inositol has been mainly used as a supplement in treating several pathologies such as polycystic ovary syndrome (PCOS), metabolic syndrome, type 2 diabetes mellitus (T2DM) and gestational diabetes (GDM). In the case of GDM, a condition defined as a glucose impairment first detected in pregnancy, a preventive role of inositol for GDM onset was recognized. In addition, inositol has been studied as a therapeutic option for the treatment of GDM and T2DM. The main effect of inositol is decreasing the level of insulin resistance. Consequently, a potential role of inositol as a treatment option could be hypothesized for other conditions typically characterized by insulin resistance like metabolic syndrome and obesity.
Zinc also plays an important role in insulin action and carbohydrate metabolism. It may also have a protective role in the prevention of atherogenesis. Several human studies have demonstrated that Zinc supplementation reduces total cholesterol, LDL cholesterol and triglycerides, in addition to increasing the HDL cholesterol levels. Studies have shown that diabetes is accompanied by hypozincemia and high levels of Zinc in urine. In addition Zinc is also an integral part of key anti-oxidant enzymes and Zinc deficiency impairs their synthesis, resulting in increased oxidative stress.
A supplementation with Myo-Inositol and Zinc could represent a valid strategy in paediatric obesity in addiction to a standard approach. The purpose of our study is to evaluate the supplementation of Myo-inositol and Zinc in the treatment of paediatric obesity.
Study design: A single-center pilot open-label randomized control trial. Population: The study will comprise a total of 60 subjects of both sexes, with pubertal stage ≥ 3 according to the Tanner stage, obese according to the IOTF criteria (International Obesity Task Force), diet naïve or with failure of weight loss (defined as -1 kg/m2 BMI in 1 year).
Intervention: Patients will be randomized in a open-label, into two groups homogeneous for number and sex of the subjects. One group (group "active") will receive the supplementation with Myoinositol and Zinc (active product) and the other group (group "Placebo") will receive a placebo for a total of 3 months of treatment.
Dietary restriction: The standard diet will be distributed with 55-60% of carbohydrates, 25-30% lipids and 15% proteins, and will be performed in accordance with the calories of an isocaloric balanced diet calculated throughout the Italian LARN Guidelines for age and gender (Italian Society of Human Nutrition, 2014), inspired to Mediterranean pyramid.
Physical activity: all subjects will receive general recommendations about performing physical activity.
Randomization: Participants will be randomly assigned in a 1:1 to active intervention Group (Active Group) or Placebo Group.
Timing: Patients will be evaluated firstly at time of enrollment (V0) and at the end of the end of the study (V1).
The following anthropometric measures, biochemical and ultrasound evaluations and questionnaires will be obtained:
Anthropometric measures:
Nutritional and physical activity measurements:
Information retrieval: A case report form (CRF) will be completed for each subject included in the study. The source documents will be the hospital's or the physician's chart.
Statistical e sample size: A sample of 23 individuals has been estimated to be sufficient to demonstrate a difference of 2 points of HOMA-IR (Prodam F et al, 2013) with 90% power and a significance level of 95% and a drop-out rate of 10% using the Student test. Statistical significance will be assumed at P\< 0.05. The statistical analysis will be performed with SPSS for Windows version 17.0 (SPSS Inc., Chicago, IL, USA).
Organization characteristics: The study will be conducted at the Pediatric Endocrine Service of Division of Pediatrics, Department of Health Sciences, University of Piemonte Orientale, in Novara.
All blood samples will be measured evaluated using standardized methods in the Hospital's Chemistry Laboratory, previously described (Prodam F et al., 2014 - Prodam F et al., 2016).
Good Clinical Practice: The protocol will be conducted in accordance with the declaration of Helsinki. Informed consent will be obtained from all parents.
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
This study's enrollment of 56 is below the median of 100 across 870 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Azienda Ospedaliero Universitaria Maggiore della Carita is the lead sponsor of 55 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
This arm will receive a supplementation with Zinc and Myo-inositol once a day.
Dietary Supplement: Zinc · Drug: Myoinositol
This arm will receive a supplementation with a same product equal to the active product but without Zinc and Myo-inositol inside.
Drug: Placebos
In this active Group there will be a supplementation with Zinc (5 mg), Myo-inositol (2000 mg) and GOS (Galacto-oligosaccharides) of Pisum sativum (1000 mg)
In this placebo Group there will be a supplementation with a product placebo equal to the active product with GOS (Galacto-oligosaccharides) of Pisum sativum(1000 mg) but without Zinc and Myo-inositol.
In this active Group there will be a supplementation with Zinc (5 mg), Myo-inositol (2000 mg) and GOS (Galacto-oligosaccharides) of Pisum sativum (1000 mg)
Change in HOMA-IR index
Evaluate if after the treatment with Myoinositol and Zinc supplementation there is a variation of HOMA-IR index. Evaluate if after the treatment with probiotic there is a variation of HOMA-IR index.
Time frame: Change from baseline HOMA-IR (V0) at 3 months (V1).
Change in glucose level during oral glucose tolerance test (OGTT)
Evaluate if after the treatment with Myoinositol and Zinc supplementation there is a reduction of glucose values during the OGTT at time 0' e 120' after oral glucose tolerance test.
Time frame: Change from Baseline OGTT (V0) at 3 months (V1)
Metabolic control: Improvement of metabolic risk factors
Evaluate any variation of serum lipids, leptin, adiponectin, GLP1 and insulin during OGTT.
Time frame: Change from baseline lipid profile, insulin, leptin, adiponectin, GLP1 (V0) at 3 months (V1)
Change in inflammatory cytokines.
Evaluate new cytokines and metabolites that regulates hormone metabolism.
Time frame: Change from Baseline cytokines and metabolites (V0) at 3 months (V1).
Plan to share: No
Ran from Feb 2018 to primary completion in Dec 2023, 70 months.
Of 14 phase 4 interventional studies under Pediatric Obesity, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 70. This study's 70 months is above that.
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Zinc · Inositol
Azienda Ospedaliero Universitaria Maggiore della Carita