Policaptil Gel Retard® in Overweight and Mild Obese Subjects

NCT03423368 | Completed

• 1 other identifier: POLI-14-1
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Overweight and Obesity

Keywords

Libramed; Policaptil Gel Retard; Overweight; Obesity; Medical Device; glycemic profile; lipid profile

Outcome Measures

Primary Outcomes (4)

• Assessment of changes in the postprandial glycemic profile - V4 versus V3 - OGTT

  OGTT

  day 30 Vs. day 0

• Assessment of changes in the postprandial glycemic profile - V4 versus V3 - fasting insulin

  HOMA index and HbA1c values evaluation

  day 30 Vs. day 0

• Assessment of changes in the postprandial glycemic profile - V4 versus V3 - HOMA index

  HOMA index

  day 30 Vs. day 0

• Assessment of changes in the postprandial glycemic profile - V4 versus V3 - HbA1c

  HbA1c

  day 30 Vs. day 0

Secondary Outcomes (14)

• Postprandial lipid profile - V4 versus V3

  day 30 Vs. day 0

• Postprandial glycemic profile after a single consumption of the product - V2 versus V3 - OGTT

  day -10 Vs. day 0

• Postprandial glycemic profile after a single consumption of the product - V2 versus V3 - fasting insulin

  day -10 Vs. day 0

• Postprandial glycemic profile after a single consumption of the product - V2 versus V3 - HOMA index

  day -10 Vs. day 0

• Postprandial glycemic profile after a single consumption of the product - V2 versus V3 - HbA1c

  day -10 Vs. day 0

Study Arms (2)

Libramed

EXPERIMENTAL

Each patient will be admistered 6 tablets/day (3 tablets before lunch, 3 tablets before dinner) of Libramed for 30 days

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

Device: Placebo

Interventions

Libramed DEVICE

Policaptil Gel Retard

Libramed

Placebo DEVICE

Placebo-comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Aboca Spa Societa' Agricola: lead
• Sprim Advanced Life Sciences: collaborator

Study Sites (1)

Azienda Ospedaliera Padova

Padua, 35128, Italy

Location

Related Links

• Related Info

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: February 6, 2018
• Study Start: February 26, 2015
• Primary Completion: January 22, 2018
• Study Completion: February 9, 2018
• Last Updated: February 13, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)