Clinical trial NCT03537235: Evaluation of Libramed in Obesity Treatment
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Libramed
Policaptil Gel retard
Overweigth
Obesity
Medical Device
glycemic profile
incretin
Lead sponsor: Aboca Spa Societa' Agricola
Sponsor class: INDUSTRY
Collaborators: name: Sprim Advanced Life Sciences
First posted: 2018-05-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of postprandial incretin axis activity
timeFrame: day 1 to day 91
measure: Evaluation of postprandial glycemic profile
timeFrame: day 1 to day 91
measure: Evaluation of triglycerides levels
timeFrame: day 1 to day 91
measure: Evaluation of satiety feeling
timeFrame: day 1 to day 91
Secondary outcomes:
measure: Evaluation of postprandial incretin axis activity - single dose assessment
timeFrame: day -6 to day 1
measure: Evaluation of postprandial glycemic profile - single dose assessment
timeFrame: day -6 to day 1
measure: Evaluation of postprandial triglycerides - single dose assessment
timeFrame: day -6 to day 1
measure: Evaluation of satiety feeling - single dose assessment
timeFrame: day -6 to day 1
measure: Evaluation of reduction in subsequent food consumption in relation to macronutrients content in test meals.
timeFrame: day -6 and day 84
measure: Body Mass assessment
timeFrame: day-7, day-6, day-4, day-2, day0, day28, day56, day84, day85, day87, day89, day91
measure: Fat Mass assessment
timeFrame: day-7, day-6, day-4, day-2, day0, day28, day56, day84, day85, day87, day89, day91
measure: Waist circumference assessment
timeFrame: day-7, day-6, day-4, day-2, day0, day28, day56, day84, day85, day87, day89, day91
measure: Fasting glucose levels assessment
timeFrame: day 84 to day 91
measure: Fasting insulin levels assessment
timeFrame: day 84 to day 91
measure: Fasting lipids levels assessment
timeFrame: day 84 to day 91
measure: Fasting incretin axis activity
timeFrame: day 84 to day 91
measure: Safety and tolerability
timeFrame: day -7 to day 91
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: Metabolic Management Center "LINIA"
Study officials:
References: