Evaluation of Libramed in Obesity Treatment

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Device: Placebo; Device: Libramed

• Registration Number: NCT03537235
• Lead Sponsor: Aboca Spa Societa' Agricola

Brief Summary

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

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 Timeline

• Study Start: 2015-06-29
• Study First Submitted: 2018-02-09
• Study First Submitted QC: 2018-05-15
• Study First Posted: 2018-05-25
• Primary Completion: 2019-02-22
• Study Completion: 2019-02-22
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-29
• Last Update Posted: 2019-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	3 tablets of Placebo 2 twice a day 15 minutes before meals for 3 months.
Libramed	Libramed	3 tablets of Libramed 2 twice a day 15 minutes before meals for 3 months.

Primary Outcome Measures

Name	Time	Method
Evaluation of postprandial incretin axis activity	day 1 to day 91	incretin axis activity
Evaluation of postprandial glycemic profile	day 1 to day 91	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).
Evaluation of triglycerides levels	day 1 to day 91	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).
Evaluation of satiety feeling	day 1 to day 91	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).

Secondary Outcome Measures

Name	Time	Method
Fasting lipids levels assessment	day 84 to day 91	lipids measurements will be collected on visits 8, 9, 10, 11, 12 on the fasting state.
Evaluation of postprandial triglycerides - single dose assessment	day -6 to day 1	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).
Waist circumference assessment	day-7, day-6, day-4, day-2, day0, day28, day56, day84, day85, day87, day89, day91	waist circumference will be measured on each study visit.
Fasting insulin levels assessment	day 84 to day 91	insulin measurements will be collected on visits 8, 9, 10, 11, 12 on the fasting state.
Evaluation of satiety feeling - single dose assessment	day -6 to day 1	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).
Evaluation of postprandial incretin axis activity - single dose assessment	day -6 to day 1	incretin axis activity in postprandial 6-hours observations (6 time collections 1, 2, 3, 4, 5, 6 hours after the test meal intake).
Evaluation of postprandial glycemic profile - single dose assessment	day -6 to day 1	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).
Body Mass assessment	day-7, day-6, day-4, day-2, day0, day28, day56, day84, day85, day87, day89, day91	Body mass will be measured on each study visit.
Fasting incretin axis activity	day 84 to day 91	incretin axis activity measurements will be collected on visits 8, 9, 10, 11, 12 on the fasting state.
Evaluation of reduction in subsequent food consumption in relation to macronutrients content in test meals.	day -6 and day 84	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.
Fat Mass assessment	day-7, day-6, day-4, day-2, day0, day28, day56, day84, day85, day87, day89, day91	Fat mass will be measured on each study visit.
Fasting glucose levels assessment	day 84 to day 91	glucose measurements will be collected on visits 8, 9, 10, 11, 12 on the fasting state.
Safety and tolerability	day -7 to day 91	Clinical safety will be assessed by physical examination at the V1, V4, V8, V12.

Trial Locations

Locations (1)

Metabolic Management Center "LINIA"; 🇵🇱 Katowice, Poland