NCT03537235

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 29, 2015

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 25, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2019

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

3.7 years

First QC Date

February 9, 2018

Last Update Submit

May 29, 2019

Conditions

Overweight and Obesity

Keywords

LibramedPolicaptil Gel retardOverweigthObesityMedical Deviceglycemic profileincretin

Outcome Measures

Primary Outcomes (4)

  • Evaluation of postprandial incretin axis activity

    incretin axis activity

    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).

    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).

    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).

    day 1 to day 91

Secondary Outcomes (13)

  • Evaluation of postprandial incretin axis activity - single dose assessment

    day -6 to day 1

  • Evaluation of postprandial glycemic profile - single dose assessment

    day -6 to day 1

  • Evaluation of postprandial triglycerides - single dose assessment

    day -6 to day 1

  • Evaluation of satiety feeling - single dose assessment

    day -6 to day 1

  • Evaluation of reduction in subsequent food consumption in relation to macronutrients content in test meals.

    day -6 and day 84

  • +8 more secondary outcomes

Study Arms (2)

Libramed

EXPERIMENTAL

3 tablets of Libramed 2 twice a day 15 minutes before meals for 3 months.

Device: Libramed

Placebo

PLACEBO COMPARATOR

3 tablets of Placebo 2 twice a day 15 minutes before meals for 3 months.

Device: Placebo

Interventions

LibramedDEVICE
Also known as: Policaptil gel retard
Libramed
PlaceboDEVICE
Also known as: Placebo-comparator
Placebo

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Metabolic Management Center "LINIA"

Katowice, 40-767, Poland

Location

Related Links

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological 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

February 9, 2018

First Posted

May 25, 2018

Study Start

June 29, 2015

Primary Completion

February 22, 2019

Study Completion

February 22, 2019

Last Updated

May 30, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)