Effects of Intake of a Polysaccharides Mix on Metabolism, Hormones and Satiety in Obese Children.

NCT02148614 | Unknown Phase 1

• 1 other identifier: 392CEP
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

AIMS Phase 1. Verify whether the intake of LibramedR is able to induce a better endocrine and metabolic profile. Phase 2. Verify whether treatment with LibramedR for 60 days produces a better glycaemic profile after oral glucose load. SUBJECTS Will be recruited 80 obese children for phase 1 and 40 obese children for phase 2. Subjects will be randomly assigned to treatment with placebo or LibramedR with a double blind clinical trial. METHODS Experimental protocol phase 1 Each child will arrive at the UOC at 8 a.m., in fasting. A blood sample will be taken. Then patients will be given two LibramedR tablets or placebo. After 20 minutes they will be given a mixed meal (equal to 15 kcal per kg of lean body mass). Blood samples will then be taken at 30-minute intervals for the first two hours and 60 minutes for the following two hours, for the determination of metabolites and hormones for a total of 4 hours. The level of satiety will be quantified through a visual analog scale. Experimental protocol phase 2 Based on the results of the OGTT performed in recruitment phase, children will be divided into two groups: group A, children with blood glucose 2 hours after oral load higher than the median and group B, children with blood glucose 2 hours after oral load below the median. The children of group A will be randomly assigned to LibramedR treatment or placebo for 60 days, after which they will repeat Anthropometric measurements, bioelectrical impedance, OGTT and blood chemistry. They will also repeat dietary and sport anamnesis . During the 60 days, the children of both groups will receive the same dietary treatment consisting of a low-calorie and balanced diet, and recommendations to practice more sport. Every 15 days a research assistant will contact the families to reinforce treatment adherence. EXPECTED RESULTS Phase 1 LibramedR intake should cause a lower increase in postprandial blood glucose, insulin, triglycerides and a greater decrease in ghrelin levels compared to placebo treatment; Phase 2 The treatment with LibramedR should be associated with a decrease in blood glucose and insulin secretion after OGTT compared to placebo treatment.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Area under the curve of plasma glucose.

  Both placebo and intervention subjects will undergo a 4 hours lasting meal test during which blood glucose will be measured periodically and the area under the curve of plasma glucose during the test period will be then calculated for each subject.

  Meal test 4-hours frame time

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects will be randomly assigned to treatment with placebo or LibramedR with a double blind clinical trial.

Drug: Placebo

Libramed

ACTIVE COMPARATOR

Subjects will be randomly assigned to treatment with placebo or LibramedR with a double blind clinical trial.

Drug: Libramed

Interventions

Placebo DRUG

Phase 1. Two tablets in a single preprandial dose Phase 2. Two tablets daily for 60 days

Also known as: No drug

Placebo

Libramed DRUG

Phase 1. Two tablets in a single postprandial dose Phase 2. Two tablets daily for 60 days

Also known as: Policaptil Gel Retard

Libramed

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age, ethnicity (Caucasians), obesity (BMI\> cut-off of BMI for age and gender indicative of obesity, defined by the International Obesity Task Force), acceptance to take part in the study.

You may not qualify if:

• birth defects, genetic disorders, chronic diseases, obesity secondary to chronic intake of drugs or endocrine causes or genetic therapy for obesity already in progress.

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

Pediatric Diabetes and Metabolic Disorders Unit, Department of Life and Reproduction Sciences, University of Verona, 1 Piazzale Stefani

Verona, 37126, Italy

RECRUITING

Related Publications (5)

• Alipour A, Elte JW, van Zaanen HC, Rietveld AP, Castro Cabezas M. Novel aspects of postprandial lipemia in relation to atherosclerosis. Atheroscler Suppl. 2008 Sep;9(2):39-44. doi: 10.1016/j.atherosclerosissup.2008.05.007. Epub 2008 Jul 1.

  PMID: 18595782 BACKGROUND

• Murphy KG, Bloom SR. Gut hormones and the regulation of energy homeostasis. Nature. 2006 Dec 14;444(7121):854-9. doi: 10.1038/nature05484.

  PMID: 17167473 BACKGROUND

• Shay CM, Ning H, Daniels SR, Rooks CR, Gidding SS, Lloyd-Jones DM. Status of cardiovascular health in US adolescents: prevalence estimates from the National Health and Nutrition Examination Surveys (NHANES) 2005-2010. Circulation. 2013 Apr 2;127(13):1369-76. doi: 10.1161/CIRCULATIONAHA.113.001559. Epub 2013 Apr 1.

  PMID: 23547177 BACKGROUND

• Maffeis C, Surano MG, Cordioli S, Gasperotti S, Corradi M, Pinelli L. A high-fat vs. a moderate-fat meal in obese boys: nutrient balance, appetite, and gastrointestinal hormone changes. Obesity (Silver Spring). 2010 Mar;18(3):449-55. doi: 10.1038/oby.2009.271. Epub 2009 Aug 27.

  PMID: 19713952 BACKGROUND

• Verbeke K, Ferchaud-Roucher V, Preston T, Small AC, Henckaerts L, Krempf M, Wang H, Vonk RJ, Priebe MG. Influence of the type of indigestible carbohydrate on plasma and urine short-chain fatty acid profiles in healthy human volunteers. Eur J Clin Nutr. 2010 Jul;64(7):678-84. doi: 10.1038/ejcn.2010.92. Epub 2010 May 26.

  PMID: 20502475 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Claudio Maffeis, MD

  Pediatric Diabetes and Metabolic Disorders Unit, Department of Life and Reproduction Sciences, University of Verona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anita Morandi, MD

CONTACT

00390458127659; anita.morandi@univr.it

Claudio Maffeis, MD

CONTACT

00390458127664; claudio.maffeis@univr.it

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 23, 2014
• First Posted: May 28, 2014
• Study Start: January 1, 2014
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 13, 2021

Record last verified: 2021-01

Locations

IT (1)