Evaluation of Libramed in Obesity Treatment (ELOT)

Randomized, Double-blind, Placebo-controlled Group, Single Center Study to Evaluate the Effect of 3 Months Policaptil Gel Retard Use on Postprandial Incretin Hormones Release and Satiety in Obese Women Regardless of Macronutrients Intake as Well as Body Mass Changes.

Randomized, double-blind, placebo-controlled study aimed at evaluating the effects of a 3-months treatment with Policaptil Gel Retard on postprandial incretin hormones release and satiety in obese women

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Device: Placebo; Device: Libramed

Detailed Description

Double-blind, randomized, placebo-controlled, parallel-group study.

This study will in made of 3 phases:

• The assessment of standard dose (3 tablets) of Libramed or placebo on the incretin hormones release and satiety sensation in obese women after ingestion of four test meal administered with one day interval - run-in period, to assess incretin hormones release and satiety sensation in obese women
• A double-blind phase in which the treament with Libramed/Placebo will be administered for 3 months.
• A post (3-months) treatment assessment of the incretin hormones release and satiety sensation after ingestion of four test meals - follow-up period.

During the screening visit (V1, Week -1) patients will be evaluated with regard to the inclusion and exclusion criteria that will permit their entry into the run-in period. The results of the laboratory analyses such as lipids, glucose and insulin levels needed to check subjects' eligibility at the time of randomization [baseline visit (V2)] will be performed at the screening visit. The run-in period starts on day 2 of the menstrual cycle and ends not later than 12 days of menstrual cycle.

During the four visits of run-in period (V2, V3, V4 and V5) will be assessed the effect of double-blind single dose of Libramed or placebo on postprandial incretin axis activity, glucose and triglycerides levels, satiety feeling and subsequent food consumption in relation to macronutrients content in test meals intake. During the visit V2 patient will be trained on diary completion.

On the first visit of this period (V5) patient previously randomized on the first visit of the run-in period (V2) will receive the first kit of Libramed or placebo. Each patient will self-administer 3 tablets of Libramed or placebo 2 times per day 15 minutes before breakfast and lunch. The dose of Libramed or placebo will be stable during the treatment period.

During the visit V5 patient will be trained on the Libramed or placebo self-administration, patient's diary completion and on diet and physical activity recommendation.

The follow-up period includes four visits (from V9 to V12), in the week immediately after the last intake of Libramed or placebo. The first visit of the follow-up period (V9) will take place the day immediately after the last intake of Libramed or placebo. The visits 9 to 12 (V9, V10, V11, V12) will take place with one day interval from each other, during the week after the last dose of Libramed or placebo use. On these visits the test meals will be administered and postprandial incretin axis, glucose and triglycerides levels as well as satiety feeling will be assessed.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Katowice, Poland, 40-767
    • Metabolic Management Center "LINIA"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• BMI 30.0-39.9 kg/m2,
• serum fasting glucose and insulin in normal ranges (- glucose ≤ 100 mg/dl, insulin ≤ 15 uIU/ml)
• HOMA-IR < 2.5 (normal range for insulin sensitivity among Polish population),
• stable body mass in the last 3 months (not more than 2 kg),
• do not use any hypocaloric diet in the last 6 months,
• not changed then realized before physical activity in the last 3 months,
• the lack of any known comorbidities,
• do not use any drugs including contraceptive
• capability to understand the study procedures and provide written informed consent.

Exclusion Criteria:

• All chronic and acute disease of the digestive tract in medical history,
• smoking,
• more than 3 alcoholic drinks per week (bear, glass of wine, and 50 ml vodka)
• no patient co-operation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Libramed; 3 tablets of Libramed 2 twice a day 15 minutes before meals for 3 months.	Device: Libramed; Other Names: Policaptil gel retard
Placebo Comparator: Placebo; 3 tablets of Placebo 2 twice a day 15 minutes before meals for 3 months.	Device: Placebo; Other Names: Placebo-comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of postprandial incretin axis activity	incretin axis activity	day 1 to day 91
Evaluation of postprandial glycemic profile	blood samples for glucose measurements ( will be collected on visits 1, 2, 3, 4 and 8, 9, 10, 11, 12 on the fasting state and during the postprandial 6-hours observations (6 time collections 1, 2, 3, 4, 5, 6 hours after the test meal intake).	day 1 to day 91
Evaluation of triglycerides levels	Blood samples for triglycerides measurements will be collected on visits 1, 2, 3, 4 and 8, 9,10,11,12 on the fasting state and during the postprandial 6-hours observations (6 time collections 1, 2, 3, 4, 5, 6 hours after the test meal intake).	day 1 to day 91
Evaluation of satiety feeling	On visit 2 and 8 the subjective fasting satiety and hunger sensation will be assessed on the basis of visual analogue scale (VAS) at the baseline (V2) and at the end of the double-blind treatment period (V8). In addition fasting and postprandial VAS scales will be filled by the test 5 minutes before Libramed product or placebo administration, 5 minutes before eating a test meal and 1, 2, 3, 4, 5, 6 hour after test meal consumption during the run-in period (V5) and follow-up period (V9-V12).	day 1 to day 91

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of postprandial incretin axis activity - single dose assessment	incretin axis activity in postprandial 6-hours observations (6 time collections 1, 2, 3, 4, 5, 6 hours after the test meal intake).	day -6 to day 1
Evaluation of postprandial glycemic profile - single dose assessment	Blood samples for glucose measurements will be collected on visits 1, 2, 3, 4 and during the postprandial 6-hours observations (6 time collections 1, 2, 3, 4, 5, 6 hours after the test meal intake).	day -6 to day 1
Evaluation of postprandial triglycerides - single dose assessment	Blood samples for triglycerides measurements will be collected on visits 1, 2, 3, 4 and during the postprandial 6-hours observations (6 time collections 1, 2, 3, 4, 5, 6 hours after the test meal intake).	day -6 to day 1
Evaluation of satiety feeling - single dose assessment	Fasting and postprandial 100 mm Visual Analog Scale (VAS) (from "no symptoms" to "overwhelming symptoms") will be filled by the test 5 minutes before Libramed product or placebo administration, 5 minutes before eating a test meal and 1, 2, 3, 4, 5, 6 hour after test meal consumption during the run-in period (V5).	day -6 to day 1
Evaluation of reduction in subsequent food consumption in relation to macronutrients content in test meals.	On visit 2 and 8 the food preferences will be assessed at the beginning and end of the study with its own survey takes into account the ten products of protein, fat and carbohydrate. To each product is assigned one point. Total points in the products group will be indicative for food preferences.	day -6 and day 84
Body Mass assessment	Body mass will be measured on each study visit.	day-7, day-6, day-4, day-2, day0, day28, day56, day84, day85, day87, day89, day91
Fat Mass assessment	Fat mass will be measured on each study visit.	day-7, day-6, day-4, day-2, day0, day28, day56, day84, day85, day87, day89, day91
Waist circumference assessment	waist circumference will be measured on each study visit.	day-7, day-6, day-4, day-2, day0, day28, day56, day84, day85, day87, day89, day91
Fasting glucose levels assessment	glucose measurements will be collected on visits 8, 9, 10, 11, 12 on the fasting state.	day 84 to day 91
Fasting insulin levels assessment	insulin measurements will be collected on visits 8, 9, 10, 11, 12 on the fasting state.	day 84 to day 91
Fasting lipids levels assessment	lipids measurements will be collected on visits 8, 9, 10, 11, 12 on the fasting state.	day 84 to day 91
Fasting incretin axis activity	incretin axis activity measurements will be collected on visits 8, 9, 10, 11, 12 on the fasting state.	day 84 to day 91
Safety and tolerability	Clinical safety will be assessed by physical examination at the V1, V4, V8, V12.	day -7 to day 91

Collaborators and Investigators

• Sponsor: Aboca Spa Societa' Agricola
• Collaborators: Sprim Advanced Life Sciences

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2015
• Primary Completion (Actual): February 22, 2019
• Study Completion (Actual): February 22, 2019

Study Registration Dates

• First Submitted: February 9, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (Actual): May 25, 2018

Study Record Updates

• Last Update Posted (Actual): May 30, 2019
• Last Update Submitted That Met QC Criteria: May 29, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Obesity; incretin; Medical Device; Libramed; glycemic profile; Policaptil Gel retard; Overweigth
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: ELOT-14-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No