NCT02148614

Intake of a Polysaccharides Mix (LibraMedR) in Obese Children. 1. Postprandial Effects on Metabolism, Hormones and Satiety; 2. Effects on Body Fat, Glucide and Fat Metabolism After a 60-day Treatment.

Status unknown Phase 1/Phase 2 Last updated 12 January 2021

What this trial tests

Phase 1/Phase 2 trial testing Placebo in Obesity in 120 participants. Status unknown.

Timeline

1 January 2014

Primary endpoint
1 September 2021

1 December 2021

Quick facts

Lead sponsor	Azienda Ospedaliera Universitaria Integrata Verona
Phase	Phase 1/Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	120
Start date	1 January 2014
Primary completion	1 September 2021
Estimated completion	1 December 2021
Sites	1 location across Italy

Drugs / interventions tested

• Placebo
• Libramed — full drug profile →

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona — full company profile →

Who can join

Adults 8 to 12, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Area under the curve of plasma glucose.
  Time frame: Meal test 4-hours frame time
  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.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Policaptil Gel Retard Intake Reduces Postprandial Triglycerides, Ghrelin and Appetite in Obese Children: A Clinical Trial.
   Fornari E, Morandi A, Piona C, Tommasi M, et al · · 2020 · cited 8× · PMID 31947628 · DOI 10.3390/nu12010214