CompletedNot Applicable

Evaluation of Libramed in Obesity Treatment

Poland40 participantsStarted 2015-06-29

Plain-language 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

Who can participate

Age range

20 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluation of postprandial incretin axis activity

Timeframe: day 1 to day 91

Evaluation of postprandial glycemic profile

Timeframe: day 1 to day 91

Evaluation of triglycerides levels

Timeframe: day 1 to day 91

Evaluation of satiety feeling

Timeframe: day 1 to day 91

Trial details

NCT IDNCT03537235

SponsorAboca Spa Societa' Agricola

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-02-22

View on ClinicalTrials.gov More Overweight and Obesity trials

Who can participate

Age range

20 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.