Completed

ELOTEffects of Libramed on Incretin Hormones Release and Satiety in Obese Women

Study Aim

This study aims to evaluate how Libramed affects the release of incretin hormones and feelings of satiety in obese women, by observing postprandial glycemic profiles, incretin axis activity, satiety feelings, and triglycerides levels.

What is being tested

Libramed

+ Placebo

Device

Who is being recruted

Body Weight+5

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

From 20 to 35 Years

+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled

Interventional

Study Start: June 2015

See protocol details

Summary

Principal SponsorAboca Spa Societa' Agricola

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 29, 2015

Actual date on which the first participant was enrolled.

This study focuses on understanding the effects of a medicine called Libramed on obese women. The main goal is to observe how this medicine influences hormones that control hunger and satisfaction after eating, regardless of the type of food consumed. Additionally, the study aims to evaluate changes in body weight. This research is significant as it could potentially provide a new approach to managing obesity and related health challenges. The study is divided into three phases. Initially, the effect of a single dose of Libramed or a placebo on hunger hormones and feelings of satisfaction will be assessed. This is followed by a double-blind phase where participants will take Libramed or a placebo for three months. Lastly, the hormones and feelings of satisfaction will be reassessed. Participants will take Libramed or a placebo twice daily, 15 minutes before breakfast and lunch. The impact of the medicine will be measured through blood samples, which will evaluate glucose and triglyceride levels, and through self-reported feelings of hunger and satisfaction. Participants will also be advised on diet and physical activity.

Official TitleRandomized, 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.

NCT03537235

Principal SponsorAboca Spa Societa' Agricola

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Female

Biological sex of participants that are eligible to enroll.

From 20 to 35 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweight

Criteria

9 inclusion criteria required to participate

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),

Show More Criteria

4 exclusion criteria prevent from participating

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

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

3 tablets of Libramed 2 twice a day 15 minutes before meals for 3 months.

Group II

Placebo

3 tablets of Placebo 2 twice a day 15 minutes before meals for 3 months.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Metabolic Management Center "LINIA"

Katowice, PolandOpen Metabolic Management Center "LINIA" in Google Maps

CompletedOne Study Center