Evaluation of Libramed in Obesity Treatment

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.

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.