Overweight and ObesityELOTNCT03537235
Evaluation of Libramed in Obesity Treatment
A study testing Libramed in people with Overweight and Obesity, run by Aboca Spa Societa' Agricola at 1 site in Poland.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Libramed
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 29 Jun 2015to 22 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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,
Show all 9Show fewer
- the lack of any known comorbidities,
- do not use any drugs including contraceptive
- capability to understand the study procedures and provide written informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- Libramed, Placebo
- Keywords
- Libramed, Policaptil Gel retard, Overweigth, Obesity, Medical Device, glycemic profile, incretin
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LibramedDevice
Also called Policaptil gel retard
PlaceboDevice
Also called Placebo-comparator
| Study group | Role | What they receive |
|---|---|---|
| Libramed | Experimental | 3 tablets of Libramed 2 twice a day 15 minutes before meals for 3 months. Receives: Device: Libramed |
| Placebo | Placebo comparator | 3 tablets of Placebo 2 twice a day 15 minutes before meals for 3 months. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of postprandial incretin axis activity
incretin axis activity
Measured: day 1 to day 91
Evaluation of postprandial glycemic profile
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).
Measured: day 1 to day 91
Evaluation of triglycerides levels
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).
Measured: day 1 to day 91
Evaluation of satiety feeling
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).
Measured: day 1 to day 91
Secondary outcomes (13)
Evaluation of postprandial incretin axis activity - single dose assessment
incretin axis activity in postprandial 6-hours observations (6 time collections 1, 2, 3, 4, 5, 6 hours after the test meal intake).
Measured: day -6 to day 1
Evaluation of postprandial glycemic profile - single dose assessment
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).
Measured: day -6 to day 1
Evaluation of postprandial triglycerides - single dose assessment
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).
Measured: day -6 to day 1
Evaluation of satiety feeling - single dose assessment
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).
Measured: day -6 to day 1
Evaluation of reduction in subsequent food consumption in relation to macronutrients content in test meals.
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.
Measured: day -6 and day 84
Body Mass assessment
Body mass will be measured on each study visit.
Measured: day-7, day-6, day-4, day-2, day0, day28, day56, day84, day85, day87, day89, day91
Fat Mass assessment
Fat mass will be measured on each study visit.
Measured: day-7, day-6, day-4, day-2, day0, day28, day56, day84, day85, day87, day89, day91
Waist circumference assessment
waist circumference will be measured on each study visit.
Measured: day-7, day-6, day-4, day-2, day0, day28, day56, day84, day85, day87, day89, day91
Fasting glucose levels assessment
glucose measurements will be collected on visits 8, 9, 10, 11, 12 on the fasting state.
Measured: day 84 to day 91
Fasting insulin levels assessment
insulin measurements will be collected on visits 8, 9, 10, 11, 12 on the fasting state.
Measured: day 84 to day 91
Fasting lipids levels assessment
lipids measurements will be collected on visits 8, 9, 10, 11, 12 on the fasting state.
Measured: day 84 to day 91
Fasting incretin axis activity
incretin axis activity measurements will be collected on visits 8, 9, 10, 11, 12 on the fasting state.
Measured: day 84 to day 91
Safety and tolerability
Clinical safety will be assessed by physical examination at the V1, V4, V8, V12.
Measured: day -7 to day 91
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start29 Jun 2015
- Primary completion22 Feb 2019
- Study completion22 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aboca Spa Societa' Agricola
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sprim Advanced Life Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537235
- Sponsor's protocol ID
- ELOT-14-2
- Acronym
- ELOT
- Status last verified
- May 2019
- First submitted
- 9 Feb 2018
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03537235
- Acronym / sponsor ID
- ELOT / ELOT-14-2
- Conditions
- Overweight and Obesity
- Keywords
- Libramed, Policaptil Gel retard, Overweigth, Obesity, Medical Device, glycemic profile, incretin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aboca Spa Societa' AgricolaIndustry (pharma, biotech, devices)
- Collaborators
- Sprim Advanced Life Sciences
- Study start
- 29 Jun 2015 (actual)
- Primary completion
- 22 Feb 2019 (actual)
- Study completion
- 22 Feb 2019 (actual)
- First posted
- 25 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Libramed | Experimental | Device: Libramed3 tablets of Libramed 2 twice a day 15 minutes before meals for 3 months. |
| Placebo | Placebo comparator | Device: Placebo3 tablets of Placebo 2 twice a day 15 minutes before meals for 3 months. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LibramedAlso: Policaptil gel retard | Device | Libramed |
| PlaceboAlso: Placebo-comparator | Device | Placebo |
Primary outcome
Evaluation of postprandial incretin axis activity
Time frame: day 1 to day 91
incretin axis activity
Evaluation of postprandial glycemic profile
Time frame: 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
Time frame: 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
Time frame: 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).
13 secondary outcomes
Evaluation of postprandial incretin axis activity - single dose assessment
Time frame: day -6 to day 1
Evaluation of postprandial glycemic profile - single dose assessment
Time frame: day -6 to day 1
Evaluation of postprandial triglycerides - single dose assessment
Time frame: day -6 to day 1
Evaluation of satiety feeling - single dose assessment
Time frame: day -6 to day 1
Evaluation of reduction in subsequent food consumption in relation to macronutrients content in test meals.
Time frame: day -6 and day 84
Body Mass assessment
Time frame: day-7, day-6, day-4, day-2, day0, day28, day56, day84, day85, day87, day89, day91
Fat Mass assessment
Time frame: day-7, day-6, day-4, day-2, day0, day28, day56, day84, day85, day87, day89, day91
Waist circumference assessment
Time frame: day-7, day-6, day-4, day-2, day0, day28, day56, day84, day85, day87, day89, day91
Fasting glucose levels assessment
Time frame: day 84 to day 91
Fasting insulin levels assessment
Time frame: day 84 to day 91
Fasting lipids levels assessment
Time frame: day 84 to day 91
Fasting incretin axis activity
Time frame: day 84 to day 91
Safety and tolerability
Time frame: day -7 to day 91
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Libramed in people with Overweight and Obesity, run by Aboca Spa Societa' Agricola at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of postprandial incretin axis activity (time frame: day 1 to day 91). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.