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

NCT02148614 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-01-13

No results posted yet for this study

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

Interventions

DRUG

Placebo

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

DRUG

Libramed

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

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Integrata Verona

    lead OTHER

Principal Investigators

  • Claudio Maffeis, MD · Pediatric Diabetes and Metabolic Disorders Unit, Department of Life and Reproduction Sciences, University of Verona

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2021-09-30
Completion
2021-12-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02148614 on ClinicalTrials.gov