Overweight and ObesityNCT03423368
Policaptil Gel Retard® in Overweight and Mild Obese Subjects
A study testing Libramed in people with Overweight and Obesity, run by Aboca Spa Societa' Agricola at 1 site in Italy.
Trial summary
This is a randomized, double blind, placebo controlled, interventional clinical study aimed at evaluating the effects of the medical device Libramed (Policaptil Gel Retard®) on the glycemic, lipid and weight profile in overweight and mild obese subjects Read more about this study
- Who is it for?
- Ages 18 to 60 years
- 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
- 67 participants
- Where
- 1 siteItaly
- Study dates
- 26 Feb 2015to 9 Feb 2018
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female subjects 18 - 60 years old (18 and 60 included).
- BMI ≥ 25 Kg/m2 and ≤ 34.9 Kg/m2.
- Stable body weight for the 3 months before enrollment.
- Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects.
- Subjects who agree not to alter their diet in any way for the duration of the trial and to maintain it at steady state (according to the forbidden food ingredients or supplements, that have to be avoided, as outlined in the study protocol), apart from the Treatment Period, during which they agree to follow the assigned diet.
- Subjects who agree not to make any major lifestyle changes (e.g. changing their exercise pattern, except as for what specified in the protocol for the Treatment Period) during the trial.
- Consent to the study and willing to comply with all its procedures.
- Postmenopausal women i.e. women who have not experienced a menstrual bleed for a minimum of 12 months or women who have undergone surgical sterilization (tubal closure or ovaries removal). Otherwise, necessity for women of childbearing potential to follow a reliable contraceptive treatment.Contraceptive treatments deemed as reliable for the study purposes are the following: hormonal contraceptives (pill, patch, vaginal ring), intrauterine devices (IUD), subcutaneous implants; barrier systems as condoms or diaphragm and methods based on the recognition of fertility from an hormonal point of view.
Who cannot join
- Gastrointestinal disorders (i.e. gastric ulcer, Inflammatory Bowel Disease (IBD) / Irritable Bowel Syndrome (IBS)),
- Uncontrolled hypertension (defined as systolic blood pressure ≥180mmHg and / or diastolic blood pressure ≥100mmHg),
- Diabetes as defined by international criteria.
- Chronic liver disease with increased serum transaminase levels (SGOT and / or SGPT > 2 UNL).
- Thyroid disorders (i.e. hyperthyroidism or hypothyroidism).
- Impaired renal function defined as estimated glomerular filtration rate (e-GFR) <60mL/min/1.73m2 according to Modification of Diet in renal Disease (MDRD) formula due to kidney failure or kidney disease / disorders.
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- Blood disorders (i.e. anemia) or subjects who donated their blood within 1 month prior to enrolment or had an important blood loss.
- Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety, compliance with the protocol and/or ability to complete the study.
- Previous gastrointestinal surgery except for appendectomy, hernia surgery, polypectomy, biopsies, colonic and gastric endoscopy.
- History of alcohol, drug or medication abuse.
- Known hypersensitivity or intolerance to the ingredients contained in the test product or the placebo; celiac subjects.
- Female subjects breastfeeding, pregnant, or planning to become pregnant during the duration of the study.
- History of eating disorder (anorexia, bulimia, binge eating disorder).
- Subjects who have taken anti-obesity medication (Orlistat) or food supplements or natural health products taken with the aim to lose weight over the 2 months prior to entry into the study.
- Prokinetic drugs cannot be started during the study period (included the follow-up period).
- The following treatments cannot be started during the study period (included the follow-up period) and the treatment with one of these treatments should be started at least 3 months prior to the beginning of the study at a stable dosage: - pharmacological treatment for dyslipidemia [(3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (the "statins"), fibrates (gemfibrozil, clofibrate and fenofibrate), niacin/nicotinic acid, bile acid binding resins (colestipol and cholestyramine)], antidepressant such as fluoxetine and bupropion, diuretics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Effects of Policaptil Gel Retard® on the Glycemic, Lipid and Weight Profile in Overweight and Mild Obese Subjects
This is a randomized, double blind, placebo controlled, interventional clinical study aimed at evaluating the effects of the medical device Libramed (Policaptil Gel Retard®) on the glycemic, lipid and weight profile in overweight and mild obese subjects
Read the detailed description
This is a randomized, double blind, placebo controlled, interventional clinical study on a medical device Visit schedule V1 (day -25) - Screening Visit During this visit (V1) the Investigator will collect information regarding the medical history, the demography, the concomitant medications. The eligibility criteria (inclusion and exclusion criteria) will be verified and during this visit the subjects who will meet the eligibility criteria will be enrolled after the signature of the informed consent form. Each subject will be informed verbally and in writing about the nature and all the requirements of the study.
A brief clinical examination will be performed, including evaluation of vital signs (pulse, systolic and diastolic pressure) and anthropometric parameters (body weight, height, BMI, waist circumference, waist-to-hip and waist-to-height ratio).
Blood and urine samples will be collected for safety routine analysis and for specific analysis to test liver and kidney functionality, glycemic and lipid profile (i.e. glycemic / lipid markers values). An Oral Glucose Tolerance Test (OGTT) will be also performed.
A diary will be given to each subject to record their daily food intake (they will be asked to avoid some food and food supplements/ingredients) and physical activity.
The next visit will be scheduled after 15 days. V2 (day -10) - postprandial metabolic profile short-term assessment - Policaptil Gel Retard® intake During this visit the Investigators will perform a brief clinical examination evaluating pulse, systolic and diastolic pressure and anthropometric parameters; a confirmation of eligibility will take place, on the basis of laboratory tests results.
A blood sample will be collected (t0) and then, after the intake of a standard dosage of Libramed®, a standard meal will be supplied. In order to record the postprandial metabolic profile blood samples will be collected 8 times: 30, 60, 90, 120, 150, 180, 240 and 300 minutes after the meal (t1, 2, 3, 4, 5, 6, 7 and 8) to evaluate the postprandial glycemic and lipid profile.
For the first 10 subjects enrolled additional 2 ml of blood will be collected to evaluate VLDL, IDL, LDL, HDL by Density Gradient Ultracentrifugation (DGU). This analysis will be performed at Clinica Medica I, Azienda Ospedaliera di Padova.
Information on adverse events and concomitant medications will be collected and recorded by the investigators.
The subjective appetite will be assessed using 100mm VASs that will have to be completed before Libramed®, before meal and 150 minutes after consumption of meal.
The next visit will be scheduled after 10 days. V3 (day 0) - postprandial metabolic profile short-term assessment - placebo and baseline / randomization During this visit the Investigators will perform a brief clinical examination evaluating pulse, systolic and diastolic pressure and anthropometric parameters; whole-body fat mass (through DXA technique) will be also evaluated.
A blood sample will be collected (t0) and then, after the intake of a standard dosage of placebo, a standard meal will be supplied. In order to record the postprandial metabolic profile blood samples will be collected 8 times: 30, 60, 90, 120, 150, 180, 240 and 300 minutes after the meal (t1, 2, 3, 4, 5, 6, 7 and 8) to evaluate the postprandial glycemic and lipid profile.
For the first 10 subjects enrolled additional 2 ml of blood will be collected to evaluate VLDL, IDL, LDL, HDL by Density Gradient Ultracentrifugation (DGU).
Moreover a blood sample will be collected in the fasting state for specific analysis to test liver and kidney functionality.
The subjective appetite will be assessed using 100mm VASs that will have to be completed before Libramed® or placebo, before meal and 150 minutes after consumption of meal.
All eligible subjects will be randomized to Policaptil Gel Retard® or placebo and a diet to be followed will be given and explained by a dietitian to all the participants. The daily dietary intake of participants during the intervention period will be set to 1200, 1500 or 1800 Kcal/day depending on the nutritional need of each participant (basal energy expenditure), calculated by means of the Harris Benedict equation (see the protocol for details). They will be asked also to make a daily walk (7000-10000 steps average, to be counted by a pedometer that they will be given too).
The subjects will be given enough study product, according to randomization, to reach the following visit. Moreover a new diary will be given to each subject and the old one will be collected.
Information on adverse events and concomitant medications will be collected and recorded by the investigators.
The next visit will be scheduled after 30 days. V4 (day 30) - end of treatment visit and postprandial metabolic profile long-term assessment - treatment During this visit the Investigators will perform a brief clinical examination evaluating pulse, systolic and diastolic pressure and anthropometric parameters; whole-body fat mass (through DXA technique) will be also evaluated.
A blood sample will be collected (t0) and then, after the intake of a standard dosage of placebo or Policaptil Gel Retard®, according to randomization, a standard meal will be supplied. In order to record the postprandial metabolic profile blood samples will be collected 8 times: 30, 60, 90, 120, 150, 180, 240 and 300 minutes after the meal (t1, 2, 3, 4, 5, 6, 7 and 8) to evaluate the postprandial glycemic and lipid profile. Moreover blood samples will be collected in the fasting state for specific analysis to test liver and kidney functionality, for safety routine analysis (also urine sample) and for specific analysis to test liver and kidney functionality.
The subjective appetite will be assessed using 100mm VASs that will have to be completed before Libramed® or placebo, before meal and 150 minutes after consumption of meal.
Information on adverse events and concomitant medications will be collected and recorded by the investigators.
The diaries and all the unused or empty containers of the study products will have to be brought back to the center, in order to evaluate the subject's adherence to the treatment.
A phone call will be scheduled after 7 days. Follow-up (day 37) A phone contact will take place to assess the safety profile (AE/SAE will be evaluated). Information on concomitant medications and a confirmation about dietary restrictions will be collected and recorded.
- Conditions
- Overweight and Obesity
- Being tested
- Libramed, Placebo
- Keywords
- Libramed, Policaptil Gel Retard, Overweight, Obesity, Medical Device, glycemic profile, lipid profile
- 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
Policaptil Gel Retard
PlaceboDevice
Placebo-comparator
| Study group | Role | What they receive |
|---|---|---|
| Libramed | Experimental | Each patient will be admistered 6 tablets/day (3 tablets before lunch, 3 tablets before dinner) of Libramed for 30 days Receives: Device: Libramed |
| Placebo | Placebo comparator | Each patient will be admistered 6 tablets/day (3 tablets before lunch, 3 tablets before dinner) of placebo for 30 days Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of changes in the postprandial glycemic profile - V4 versus V3 - OGTT
OGTT
Measured: day 30 Vs. day 0
Assessment of changes in the postprandial glycemic profile - V4 versus V3 - fasting insulin
HOMA index and HbA1c values evaluation
Measured: day 30 Vs. day 0
Assessment of changes in the postprandial glycemic profile - V4 versus V3 - HOMA index
HOMA index
Measured: day 30 Vs. day 0
Assessment of changes in the postprandial glycemic profile - V4 versus V3 - HbA1c
HbA1c
Measured: day 30 Vs. day 0
Secondary outcomes (14)
Postprandial lipid profile - V4 versus V3
Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, Apo-B
Measured: day 30 Vs. day 0
Postprandial glycemic profile after a single consumption of the product - V2 versus V3 - OGTT
OGTT
Measured: day -10 Vs. day 0
Postprandial glycemic profile after a single consumption of the product - V2 versus V3 - fasting insulin
fasting insulin
Measured: day -10 Vs. day 0
Postprandial glycemic profile after a single consumption of the product - V2 versus V3 - HOMA index
HOMA index
Measured: day -10 Vs. day 0
Postprandial glycemic profile after a single consumption of the product - V2 versus V3 - HbA1c
HbA1c
Measured: day -10 Vs. day 0
Postprandial lipid profile after a single consumption of the product - V2 versus V3
Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, Apo-B
Measured: day -10 Vs. day 0
Anthropometric parameters - body weight
body weight
Measured: day 30 Vs. day 0
Anthropometric parameters - BMI
body mass index - BMI
Measured: day 30 Vs. day 0
Anthropometric parameters -Waist circumference
Waist circumference
Measured: day 30 Vs. day 0
Anthropometric parameters - waist-to-hip ratio
waist-to-hip ratio
Measured: day 30 Vs. day 0
Anthropometric parameters - waist-to-height ratio
waist-to-height ratio
Measured: day 30 Vs. day 0
Systolic /diastolic blood pressure - V4 versus V3
Assessment of changes in the systolic /diastolic blood pressure - V4 versus V3 - comparison between groups
Measured: day 30 Vs. day 0
Dual energy X-ray absorptiometry - V4 versus V3
Measurement of whole-body fat mass, through dual energy X-ray absorptiometry (DXA) technique (Noakes et al., 2006; Frestedt et al., 2008) - V4 versus V3 - comparison between groups
Measured: day 30 Vs. day 0
Feeling of hunger and feeling of appetite - V4 versus V3
100-mm Visual Analog Scale (VAS) evaluation. From 0 (very strong hunger feeling) to 100 (very weak hunger feeling)
Measured: day 30 Vs. day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start26 Feb 2015
- Primary completion22 Jan 2018
- Study completion9 Feb 2018
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
- 67 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
- NCT03423368
- Sponsor's protocol ID
- POLI-14-1
- Status last verified
- Feb 2018
- First submitted
- 15 Jan 2018
- Last updated
- 13 Feb 2018
- 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 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effects of Policaptil Gel Retard® on the Glycemic, Lipid and Weight Profile in Overweight and Mild Obese Subjects
- ClinicalTrials.gov ID
- NCT03423368
- Acronym / sponsor ID
- POLI-14-1
- Conditions
- Overweight and Obesity
- Keywords
- Libramed, Policaptil Gel Retard, Overweight, Obesity, Medical Device, glycemic profile, lipid profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Aboca Spa Societa' AgricolaIndustry (pharma, biotech, devices)
- Collaborators
- Sprim Advanced Life Sciences
- Study start
- 26 Feb 2015 (actual)
- Primary completion
- 22 Jan 2018 (actual)
- Study completion
- 9 Feb 2018 (actual)
- First posted
- 6 Feb 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.
This is a randomized, double blind, placebo controlled, interventional clinical study aimed at evaluating the effects of the medical device Libramed (Policaptil Gel Retard®) on the glycemic, lipid and weight profile in overweight and mild obese subjects
Detailed description
This is a randomized, double blind, placebo controlled, interventional clinical study on a medical device Visit schedule V1 (day -25) - Screening Visit During this visit (V1) the Investigator will collect information regarding the medical history, the demography, the concomitant medications. The eligibility criteria (inclusion and exclusion criteria) will be verified and during this visit the subjects who will meet the eligibility criteria will be enrolled after the signature of the informed consent form. Each subject will be informed verbally and in writing about the nature and all the requirements of the study.
A brief clinical examination will be performed, including evaluation of vital signs (pulse, systolic and diastolic pressure) and anthropometric parameters (body weight, height, BMI, waist circumference, waist-to-hip and waist-to-height ratio).
Blood and urine samples will be collected for safety routine analysis and for specific analysis to test liver and kidney functionality, glycemic and lipid profile (i.e. glycemic / lipid markers values). An Oral Glucose Tolerance Test (OGTT) will be also performed.
A diary will be given to each subject to record their daily food intake (they will be asked to avoid some food and food supplements/ingredients) and physical activity.
The next visit will be scheduled after 15 days. V2 (day -10) - postprandial metabolic profile short-term assessment - Policaptil Gel Retard® intake During this visit the Investigators will perform a brief clinical examination evaluating pulse, systolic and diastolic pressure and anthropometric parameters; a confirmation of eligibility will take place, on the basis of laboratory tests results.
A blood sample will be collected (t0) and then, after the intake of a standard dosage of Libramed®, a standard meal will be supplied. In order to record the postprandial metabolic profile blood samples will be collected 8 times: 30, 60, 90, 120, 150, 180, 240 and 300 minutes after the meal (t1, 2, 3, 4, 5, 6, 7 and 8) to evaluate the postprandial glycemic and lipid profile.
For the first 10 subjects enrolled additional 2 ml of blood will be collected to evaluate VLDL, IDL, LDL, HDL by Density Gradient Ultracentrifugation (DGU). This analysis will be performed at Clinica Medica I, Azienda Ospedaliera di Padova.
Information on adverse events and concomitant medications will be collected and recorded by the investigators.
The subjective appetite will be assessed using 100mm VASs that will have to be completed before Libramed®, before meal and 150 minutes after consumption of meal.
The next visit will be scheduled after 10 days. V3 (day 0) - postprandial metabolic profile short-term assessment - placebo and baseline / randomization During this visit the Investigators will perform a brief clinical examination evaluating pulse, systolic and diastolic pressure and anthropometric parameters; whole-body fat mass (through DXA technique) will be also evaluated.
A blood sample will be collected (t0) and then, after the intake of a standard dosage of placebo, a standard meal will be supplied. In order to record the postprandial metabolic profile blood samples will be collected 8 times: 30, 60, 90, 120, 150, 180, 240 and 300 minutes after the meal (t1, 2, 3, 4, 5, 6, 7 and 8) to evaluate the postprandial glycemic and lipid profile.
For the first 10 subjects enrolled additional 2 ml of blood will be collected to evaluate VLDL, IDL, LDL, HDL by Density Gradient Ultracentrifugation (DGU).
Moreover a blood sample will be collected in the fasting state for specific analysis to test liver and kidney functionality.
The subjective appetite will be assessed using 100mm VASs that will have to be completed before Libramed® or placebo, before meal and 150 minutes after consumption of meal.
All eligible subjects will be randomized to Policaptil Gel Retard® or placebo and a diet to be followed will be given and explained by a dietitian to all the participants. The daily dietary intake of participants during the intervention period will be set to 1200, 1500 or 1800 Kcal/day depending on the nutritional need of each participant (basal energy expenditure), calculated by means of the Harris Benedict equation (see the protocol for details). They will be asked also to make a daily walk (7000-10000 steps average, to be counted by a pedometer that they will be given too).
The subjects will be given enough study product, according to randomization, to reach the following visit. Moreover a new diary will be given to each subject and the old one will be collected.
Information on adverse events and concomitant medications will be collected and recorded by the investigators.
The next visit will be scheduled after 30 days. V4 (day 30) - end of treatment visit and postprandial metabolic profile long-term assessment - treatment During this visit the Investigators will perform a brief clinical examination evaluating pulse, systolic and diastolic pressure and anthropometric parameters; whole-body fat mass (through DXA technique) will be also evaluated.
A blood sample will be collected (t0) and then, after the intake of a standard dosage of placebo or Policaptil Gel Retard®, according to randomization, a standard meal will be supplied. In order to record the postprandial metabolic profile blood samples will be collected 8 times: 30, 60, 90, 120, 150, 180, 240 and 300 minutes after the meal (t1, 2, 3, 4, 5, 6, 7 and 8) to evaluate the postprandial glycemic and lipid profile. Moreover blood samples will be collected in the fasting state for specific analysis to test liver and kidney functionality, for safety routine analysis (also urine sample) and for specific analysis to test liver and kidney functionality.
The subjective appetite will be assessed using 100mm VASs that will have to be completed before Libramed® or placebo, before meal and 150 minutes after consumption of meal.
Information on adverse events and concomitant medications will be collected and recorded by the investigators.
The diaries and all the unused or empty containers of the study products will have to be brought back to the center, in order to evaluate the subject's adherence to the treatment.
A phone call will be scheduled after 7 days. Follow-up (day 37) A phone contact will take place to assess the safety profile (AE/SAE will be evaluated). Information on concomitant medications and a confirmation about dietary restrictions will be collected and recorded.
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: LibramedEach patient will be admistered 6 tablets/day (3 tablets before lunch, 3 tablets before dinner) of Libramed for 30 days |
| Placebo | Placebo comparator | Device: PlaceboEach patient will be admistered 6 tablets/day (3 tablets before lunch, 3 tablets before dinner) of placebo for 30 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male and female subjects 18 - 60 years old (18 and 60 included).
- BMI ≥ 25 Kg/m2 and ≤ 34.9 Kg/m2.
- Stable body weight for the 3 months before enrollment.
- Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects.
- Subjects who agree not to alter their diet in any way for the duration of the trial and to maintain it at steady state (according to the forbidden food ingredients or supplements, that have to be avoided, as outlined in the study protocol), apart from the Treatment Period, during which they agree to follow the assigned diet.
Key exclusion criteria (16 listed)
- Gastrointestinal disorders (i.e. gastric ulcer, Inflammatory Bowel Disease (IBD) / Irritable Bowel Syndrome (IBS)),
- Uncontrolled hypertension (defined as systolic blood pressure ≥180mmHg and / or diastolic blood pressure ≥100mmHg),
- Diabetes as defined by international criteria.
- Chronic liver disease with increased serum transaminase levels (SGOT and / or SGPT > 2 UNL).
- Thyroid disorders (i.e. hyperthyroidism or hypothyroidism).
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 |
|---|---|---|
| LibramedPolicaptil Gel Retard | Device | Libramed |
| PlaceboPlacebo-comparator | Device | Placebo |
Primary outcome
Assessment of changes in the postprandial glycemic profile - V4 versus V3 - OGTT
Time frame: day 30 Vs. day 0
OGTT
Assessment of changes in the postprandial glycemic profile - V4 versus V3 - fasting insulin
Time frame: day 30 Vs. day 0
HOMA index and HbA1c values evaluation
Assessment of changes in the postprandial glycemic profile - V4 versus V3 - HOMA index
Time frame: day 30 Vs. day 0
HOMA index
Assessment of changes in the postprandial glycemic profile - V4 versus V3 - HbA1c
Time frame: day 30 Vs. day 0
HbA1c
14 secondary outcomes
Postprandial lipid profile - V4 versus V3
Time frame: day 30 Vs. day 0
Postprandial glycemic profile after a single consumption of the product - V2 versus V3 - OGTT
Time frame: day -10 Vs. day 0
Postprandial glycemic profile after a single consumption of the product - V2 versus V3 - fasting insulin
Time frame: day -10 Vs. day 0
Postprandial glycemic profile after a single consumption of the product - V2 versus V3 - HOMA index
Time frame: day -10 Vs. day 0
Postprandial glycemic profile after a single consumption of the product - V2 versus V3 - HbA1c
Time frame: day -10 Vs. day 0
Postprandial lipid profile after a single consumption of the product - V2 versus V3
Time frame: day -10 Vs. day 0
Anthropometric parameters - body weight
Time frame: day 30 Vs. day 0
Anthropometric parameters - BMI
Time frame: day 30 Vs. day 0
Anthropometric parameters -Waist circumference
Time frame: day 30 Vs. day 0
Anthropometric parameters - waist-to-hip ratio
Time frame: day 30 Vs. day 0
Anthropometric parameters - waist-to-height ratio
Time frame: day 30 Vs. day 0
Systolic /diastolic blood pressure - V4 versus V3
Time frame: day 30 Vs. day 0
Dual energy X-ray absorptiometry - V4 versus V3
Time frame: day 30 Vs. day 0
Feeling of hunger and feeling of appetite - V4 versus V3
Time frame: day 30 Vs. day 0
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 13 Feb 2018.
- 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 Italy.
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 8 inclusion and 16 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 13 Feb 2018. 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 Italy. 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?
Assessment of changes in the postprandial glycemic profile - V4 versus V3 - OGTT (time frame: day 30 Vs. day 0). 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 13 Feb 2018.