Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-25 @ 3:15 PM
Study NCT ID:
NCT03423368
Status:
COMPLETED
Last Update Posted:
2018-02-13
First Post:
2018-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Policaptil Gel Retard® in Overweight and Mild Obese Subjects
Sponsor:
Aboca Spa Societa' Agricola
Organization:
Study Overview
Official Title:
Assessment of the Effects of Policaptil Gel Retard® on the Glycemic, Lipid and Weight Profile in Overweight and Mild Obese Subjects
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized, double blind, placebo controlled, interventional clinical study aimed at evaluating the effects of the medical device Libramed (Policaptil Gel Retard®) on the glycemic, lipid and weight profile in overweight and mild obese subjects
Detailed Description:
This is a randomized, double blind, placebo controlled, interventional clinical study on a medical device Visit schedule V1 (day -25) - Screening Visit During this visit (V1) the Investigator will collect information regarding the medical history, the demography, the concomitant medications. The eligibility criteria (inclusion and exclusion criteria) will be verified and during this visit the subjects who will meet the eligibility criteria will be enrolled after the signature of the informed consent form. Each subject will be informed verbally and in writing about the nature and all the requirements of the study.
A brief clinical examination will be performed, including evaluation of vital signs (pulse, systolic and diastolic pressure) and anthropometric parameters (body weight, height, BMI, waist circumference, waist-to-hip and waist-to-height ratio).
Blood and urine samples will be collected for safety routine analysis and for specific analysis to test liver and kidney functionality, glycemic and lipid profile (i.e. glycemic / lipid markers values). An Oral Glucose Tolerance Test (OGTT) will be also performed.
A diary will be given to each subject to record their daily food intake (they will be asked to avoid some food and food supplements/ingredients) and physical activity.
The next visit will be scheduled after 15 days. V2 (day -10) - postprandial metabolic profile short-term assessment - Policaptil Gel Retard® intake During this visit the Investigators will perform a brief clinical examination evaluating pulse, systolic and diastolic pressure and anthropometric parameters; a confirmation of eligibility will take place, on the basis of laboratory tests results.
A blood sample will be collected (t0) and then, after the intake of a standard dosage of Libramed®, a standard meal will be supplied. In order to record the postprandial metabolic profile blood samples will be collected 8 times: 30, 60, 90, 120, 150, 180, 240 and 300 minutes after the meal (t1, 2, 3, 4, 5, 6, 7 and 8) to evaluate the postprandial glycemic and lipid profile.
For the first 10 subjects enrolled additional 2 ml of blood will be collected to evaluate VLDL, IDL, LDL, HDL by Density Gradient Ultracentrifugation (DGU). This analysis will be performed at Clinica Medica I, Azienda Ospedaliera di Padova.
Information on adverse events and concomitant medications will be collected and recorded by the investigators.
The subjective appetite will be assessed using 100mm VASs that will have to be completed before Libramed®, before meal and 150 minutes after consumption of meal.
The next visit will be scheduled after 10 days. V3 (day 0) - postprandial metabolic profile short-term assessment - placebo and baseline / randomization During this visit the Investigators will perform a brief clinical examination evaluating pulse, systolic and diastolic pressure and anthropometric parameters; whole-body fat mass (through DXA technique) will be also evaluated.
A blood sample will be collected (t0) and then, after the intake of a standard dosage of placebo, a standard meal will be supplied. In order to record the postprandial metabolic profile blood samples will be collected 8 times: 30, 60, 90, 120, 150, 180, 240 and 300 minutes after the meal (t1, 2, 3, 4, 5, 6, 7 and 8) to evaluate the postprandial glycemic and lipid profile.
For the first 10 subjects enrolled additional 2 ml of blood will be collected to evaluate VLDL, IDL, LDL, HDL by Density Gradient Ultracentrifugation (DGU).
Moreover a blood sample will be collected in the fasting state for specific analysis to test liver and kidney functionality.
The subjective appetite will be assessed using 100mm VASs that will have to be completed before Libramed® or placebo, before meal and 150 minutes after consumption of meal.
All eligible subjects will be randomized to Policaptil Gel Retard® or placebo and a diet to be followed will be given and explained by a dietitian to all the participants. The daily dietary intake of participants during the intervention period will be set to 1200, 1500 or 1800 Kcal/day depending on the nutritional need of each participant (basal energy expenditure), calculated by means of the Harris Benedict equation (see the protocol for details). They will be asked also to make a daily walk (7000-10000 steps average, to be counted by a pedometer that they will be given too).
The subjects will be given enough study product, according to randomization, to reach the following visit. Moreover a new diary will be given to each subject and the old one will be collected.
Information on adverse events and concomitant medications will be collected and recorded by the investigators.
The next visit will be scheduled after 30 days. V4 (day 30) - end of treatment visit and postprandial metabolic profile long-term assessment - treatment During this visit the Investigators will perform a brief clinical examination evaluating pulse, systolic and diastolic pressure and anthropometric parameters; whole-body fat mass (through DXA technique) will be also evaluated.
A blood sample will be collected (t0) and then, after the intake of a standard dosage of placebo or Policaptil Gel Retard®, according to randomization, a standard meal will be supplied. In order to record the postprandial metabolic profile blood samples will be collected 8 times: 30, 60, 90, 120, 150, 180, 240 and 300 minutes after the meal (t1, 2, 3, 4, 5, 6, 7 and 8) to evaluate the postprandial glycemic and lipid profile. Moreover blood samples will be collected in the fasting state for specific analysis to test liver and kidney functionality, for safety routine analysis (also urine sample) and for specific analysis to test liver and kidney functionality.
The subjective appetite will be assessed using 100mm VASs that will have to be completed before Libramed® or placebo, before meal and 150 minutes after consumption of meal.
Information on adverse events and concomitant medications will be collected and recorded by the investigators.
The diaries and all the unused or empty containers of the study products will have to be brought back to the center, in order to evaluate the subject's adherence to the treatment.
A phone call will be scheduled after 7 days. Follow-up (day 37) A phone contact will take place to assess the safety profile (AE/SAE will be evaluated). Information on concomitant medications and a confirmation about dietary restrictions will be collected and recorded.
A brief clinical examination will be performed, including evaluation of vital signs (pulse, systolic and diastolic pressure) and anthropometric parameters (body weight, height, BMI, waist circumference, waist-to-hip and waist-to-height ratio).
Blood and urine samples will be collected for safety routine analysis and for specific analysis to test liver and kidney functionality, glycemic and lipid profile (i.e. glycemic / lipid markers values). An Oral Glucose Tolerance Test (OGTT) will be also performed.
A diary will be given to each subject to record their daily food intake (they will be asked to avoid some food and food supplements/ingredients) and physical activity.
The next visit will be scheduled after 15 days. V2 (day -10) - postprandial metabolic profile short-term assessment - Policaptil Gel Retard® intake During this visit the Investigators will perform a brief clinical examination evaluating pulse, systolic and diastolic pressure and anthropometric parameters; a confirmation of eligibility will take place, on the basis of laboratory tests results.
A blood sample will be collected (t0) and then, after the intake of a standard dosage of Libramed®, a standard meal will be supplied. In order to record the postprandial metabolic profile blood samples will be collected 8 times: 30, 60, 90, 120, 150, 180, 240 and 300 minutes after the meal (t1, 2, 3, 4, 5, 6, 7 and 8) to evaluate the postprandial glycemic and lipid profile.
For the first 10 subjects enrolled additional 2 ml of blood will be collected to evaluate VLDL, IDL, LDL, HDL by Density Gradient Ultracentrifugation (DGU). This analysis will be performed at Clinica Medica I, Azienda Ospedaliera di Padova.
Information on adverse events and concomitant medications will be collected and recorded by the investigators.
The subjective appetite will be assessed using 100mm VASs that will have to be completed before Libramed®, before meal and 150 minutes after consumption of meal.
The next visit will be scheduled after 10 days. V3 (day 0) - postprandial metabolic profile short-term assessment - placebo and baseline / randomization During this visit the Investigators will perform a brief clinical examination evaluating pulse, systolic and diastolic pressure and anthropometric parameters; whole-body fat mass (through DXA technique) will be also evaluated.
A blood sample will be collected (t0) and then, after the intake of a standard dosage of placebo, a standard meal will be supplied. In order to record the postprandial metabolic profile blood samples will be collected 8 times: 30, 60, 90, 120, 150, 180, 240 and 300 minutes after the meal (t1, 2, 3, 4, 5, 6, 7 and 8) to evaluate the postprandial glycemic and lipid profile.
For the first 10 subjects enrolled additional 2 ml of blood will be collected to evaluate VLDL, IDL, LDL, HDL by Density Gradient Ultracentrifugation (DGU).
Moreover a blood sample will be collected in the fasting state for specific analysis to test liver and kidney functionality.
The subjective appetite will be assessed using 100mm VASs that will have to be completed before Libramed® or placebo, before meal and 150 minutes after consumption of meal.
All eligible subjects will be randomized to Policaptil Gel Retard® or placebo and a diet to be followed will be given and explained by a dietitian to all the participants. The daily dietary intake of participants during the intervention period will be set to 1200, 1500 or 1800 Kcal/day depending on the nutritional need of each participant (basal energy expenditure), calculated by means of the Harris Benedict equation (see the protocol for details). They will be asked also to make a daily walk (7000-10000 steps average, to be counted by a pedometer that they will be given too).
The subjects will be given enough study product, according to randomization, to reach the following visit. Moreover a new diary will be given to each subject and the old one will be collected.
Information on adverse events and concomitant medications will be collected and recorded by the investigators.
The next visit will be scheduled after 30 days. V4 (day 30) - end of treatment visit and postprandial metabolic profile long-term assessment - treatment During this visit the Investigators will perform a brief clinical examination evaluating pulse, systolic and diastolic pressure and anthropometric parameters; whole-body fat mass (through DXA technique) will be also evaluated.
A blood sample will be collected (t0) and then, after the intake of a standard dosage of placebo or Policaptil Gel Retard®, according to randomization, a standard meal will be supplied. In order to record the postprandial metabolic profile blood samples will be collected 8 times: 30, 60, 90, 120, 150, 180, 240 and 300 minutes after the meal (t1, 2, 3, 4, 5, 6, 7 and 8) to evaluate the postprandial glycemic and lipid profile. Moreover blood samples will be collected in the fasting state for specific analysis to test liver and kidney functionality, for safety routine analysis (also urine sample) and for specific analysis to test liver and kidney functionality.
The subjective appetite will be assessed using 100mm VASs that will have to be completed before Libramed® or placebo, before meal and 150 minutes after consumption of meal.
Information on adverse events and concomitant medications will be collected and recorded by the investigators.
The diaries and all the unused or empty containers of the study products will have to be brought back to the center, in order to evaluate the subject's adherence to the treatment.
A phone call will be scheduled after 7 days. Follow-up (day 37) A phone contact will take place to assess the safety profile (AE/SAE will be evaluated). Information on concomitant medications and a confirmation about dietary restrictions will be collected and recorded.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: