Effects of Intake of a Polysaccharides Mix on Metabolism, Hormones and Satiety in Obese Children.
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
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.