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CompletedNCT03052062Updated Jul 6, 2018

Tolerance Study of the Dietary Supplement Lipidrive (ECPH1-03)

A Phase 1/2 interventional study of Lipidrive in Obese, sponsored by Valbiotis. Completed at 1 site in France. Open to male participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-07-06.

Sponsored by Valbiotis · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
45 Years to 65 Years
Sex
Male
01

Study summary

The objectives of this clinical study are to determine the tolerance of dietary supplement Lipidrive through the evaluation of several parameters :

  • Various blood biological parameters
  • Urinary parameters
  • Hemodynamic indicators
  • Cardiac function
  • Anthropometric variables
Read the detailed description

Primary objectives of this study :

Evaluate the effects of two doses of the product on:

  • Various blood biological parameters for tolerance (preprandial): blood glucose, insulin, HOMA-IR, glycated hemoglobin, fructosamine, total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, oxidized LDL, us-CRP, creatinine, ASAT, ALAT, gGT, alkaline phosphatase, bilirubin, urea.
  • Urinary parameters: urea, creatinine.
  • Hemodynamic indicators: heart rate and blood pressure.
  • Cardiac function: ECG.
  • Anthropometric variables: weight, waist, hips, waist/hip ratio, body composition using bioelectric impendence analysis.

Secondary objectives of this study:

Evaluate the effects of the highest dose on:

  • Adiponectin, leptin, TNF-α, and the evolution kinetics of blood glucose and blood insulin levels following a standard breakfast, with or without the acute administration of the Lipidrive dietary supplement.

Two questionnaires (one on eating habits over 3 days and another on physical and sports activities) will be completed at various times (cf. below). A "satisfaction" questionnaire will also be completed at the end of the study.

A serum bank will be created (ghrelin, resistin, GIP, GLP-1, IL-6, IL-1 beta, CCK), and stools will be collected at V2 and V5 for subsequent microbiota analysis (aliquoting performed by the AME2P laboratory, which will send the samples to BIOFORTIS Nantes at the end of the trial).

02

Conditions studied

  • Obese
03

In context

Lead sponsor

Valbiotis is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Male
  • Aged 45 to 65 years (inclusive)
  • BMI between 30 kg/m² (inclusive) and 40 kg/m² (non-inclusive) and/or a waist/hips ratio > 0.9
  • Non-smoker or smokes maximum 10 cigarettes per day
  • Stable weight for at least 3 months before the start of the study
  • Regular physical activity for 3 months before the start of the study, subject agreeing to maintain this level of activity over the course of the study
  • Stable eating habits for 3 months before the start of the study, subject agreeing to maintain these eating habits over the course of the study
  • Willing and able to comply with the protocol, subject agreeing to give their informed written consent
  • Registered with a social security scheme
  • Subject agreeing to be registered in the national directory of volunteers participating in biomedical research

Following the biological screening conducted during the inclusion visit, run-in subjects will be included at the following visit according to the following criteria:

  • FBC with no clinically significant anomalies according to the investigator
  • ASAT ≤ 1.55 μkat/L or ≤ 92 U/L
  • ALAT ≤ 1.7 μkat/L or ≤ 101 U/L
  • gGT ≤ 2.55 μkat/L or ≤ 152 U/L
  • 45 ≤ Creatinine ≤ 104 μmol/L (± 10%)
  • Total bilirubin \< 17.1 μmol/L (± 10%)
  • 1.7 mmol/L ≤ Urea ≤ 8.3 mmol/L (± 10%)
  • us-CRP ≤ 5 mg/L (± 10%).

Exclusion criteria

Exclusion Criteria:

  • Confirmed or suspected food allergy to the test product (describe)
  • Subject with chronic condition or specific circumstances that the investigator considers incompatible with participation in the study
  • Subject taking anti-diabetic treatment
  • Subject taking lipo-regulating (fibrates, statins, nicotinic acid) or anti-dyslipidemia drugs
  • Subject consuming dietary supplements (V0 could be conducted at least 1 month after completely stopping the supplements)
  • Subject consuming grapefruit or orange juice (enzyme inhibitor)
  • Subject consuming food products supplemented with phytosterols, beta glucans, konjac, and/or cinnamon (V0 could be conducted at least 3 months after completely stopping the supplements) (list to be drawn up at the time of the study)
  • Unstable blood pressure equal to or over 160/95
  • Subject undergoing treatment that, according to the investigator, could interfere with the evaluation of the study criteria
  • Subject who has been on a low-calorie diet in the 3 months prior to the study and/or intends to go on a diet during the study
  • Subject with serious history of anorexia nervosa, bulimia or other eating disorders
  • Vegetarian or vegan
  • Extreme eating habits
  • Subject participating in another clinical study or in an exclusion period following a previous clinical study
  • Subject who has received over 4500 euros in compensation since the start of the calendar year (sum can vary according to regulations)
  • Subject with a linguistic or physical incapacity to provide written informed consent
  • Refusal to provide written consent
  • Subject deprived of liberty by administrative or judicial order, under trusteeship or guardianship
  • Subject who cannot be contacted by telephone in case of emergency
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Lipidrive

    Dose 1 : 2,6 g (4 capsules) Lipidrive per day during 12 weeks Dose 2 : 5,2 g (8 capsules) Lipidrive per day during 12 weeks, 2 weeks (wash-out period) between the 2 doses

    Dietary Supplement: Lipidrive

Interventions

  • Dietary supplementLipidrive

    LipiDrive, 4 to 8 capsules per day, oral administration. Dose 1: 2.6 g Lipidrive per day Dose 2: 5.2 g Lipidrive per day

06

What researchers measure

Primary outcomes

  1. Changes in fasting blood glucose

    Defined as the difference V3 (12 weeks) - V2 (baseline) in mmol/L

    Time frame: 12 weeks

  2. Changes in fasting blood glucose

    Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L

    Time frame: 26 weeks

  3. Changes in fasting insulinemia

    Defined as the difference V3 (12 weeks) - V2 (baseline)) in mUI/L

    Time frame: 12 weeks

  4. Changes in fasting insulinemia

    Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mUI/L

    Time frame: 26 weeks

  5. Changes in fasting HOMA-IR

    Defined as the difference V3 (12 weeks) - V2 (baseline)

    Time frame: 12 weeks

  6. Changes in fasting HOMA-IR

    Defined as the difference V5 (26 weeks) - V4 (14 weeks)

    Time frame: 26 weeks

  7. Changes in glycated hemoglobin

    Defined as the difference V3 (12 weeks) - V2 (baseline) in %

    Time frame: 12 weeks

  8. Changes in glycated hemoglobin

    Defined as the difference V5 (26 weeks) - V4 (14 weeks) in %

    Time frame: 26 weeks

  9. Changes in fasting fructosamin

    Defined as the difference V3 (12 weeks) - V2 (baseline) in µmol/L

    Time frame: 12 weeks

  10. Changes in fasting fructosamin

    Defined as the difference V5 (26 weeks) - V4 (14 weeks) in µmol/L

    Time frame: 26 weeks

  11. Changes in fasting total cholesterol

    Defined as the difference V3 (12 weeks) - V2 (baseline) in mmol/L

    Time frame: 12 weeks

  12. Changes in fasting total cholesterol

    Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L

    Time frame: 26 weeks

  13. Changes in fasting HDL cholesterol

    Defined as the difference V3 (12 weeks) - V2 (baseline) in mmol/L

    Time frame: 12 weeks

  14. Changes in fasting HDL cholesterol

    Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L

    Time frame: 26 weeks

  15. Changes in fasting LDL cholesterol

    Defined as the difference V3 (12 weeks) - V2 (baseline) in mmol/L

    Time frame: 12 weeks

  16. Changes in fasting LDL cholesterol

    Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L

    Time frame: 26 weeks

  17. Changes in fasting triglycerides

    Defined as the difference V3 (12 weeks) - V2 (baseline) in mmol/L

    Time frame: 12 weeks

  18. Changes in fasting triglycerides

    Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L

    Time frame: 26 weeks

  19. Changes in oxidized LDL

    Defined as the difference V3 (12 weeks) - V2 (baseline) in mmol/L

    Time frame: 12 weeks

  20. Changes in oxidized LDL

    Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L

    Time frame: 26 weeks

  21. Changes in us-CRP

    Defined as the difference V3 (12 weeks) - V2 (baseline) in mg/L

    Time frame: 12 weeks

  22. Changes in us-CRP

    Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L

    Time frame: 26 weeks

  23. Changes in blood creatinine

    Defined as the difference V3 (12 weeks) - V2 (baseline) in mg/dL

    Time frame: 12 weeks

  24. Changes in blood creatinine

    Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mg/dL

    Time frame: 26 weeks

  25. Changes in fasting blood levels of ASAT (Aspartate aminotransferase) and ALAT (Alanine aminotransferase)

    Defined as the difference V3 (12 weeks) - V2 (baseline) in UI/L

    Time frame: 12 weeks

  26. Changes in fasting blood levels of ASAT (Aspartate aminotransferase) and ALAT (Alanine aminotransferase)

    Defined as the difference V5 (26 weeks) - V4 (14 weeks) in UI/L

    Time frame: 26 weeks

  27. Changes in fasting blood levels of GGT (Gamma glutamyltransferase)

    Defined as the difference V3 (12 weeks) - V2 (baseline) in UI/L

    Time frame: 12 weeks

  28. Changes in fasting blood levels of GGT (Gamma glutamyltransferase)

    Defined as the difference V5 (26 weeks) - V4 (14 weeks) in UI/L

    Time frame: 26 weeks

  29. Changes in fasting alkaline phosphatase

    Defined as the difference V3 (12 weeks) - V2 (baseline) in UI/L

    Time frame: 12 weeks

  30. Changes in fasting alkaline phosphatase

    Defined as the difference V5 (26 weeks) - V4 (14 weeks) in UI/L

    Time frame: 26 weeks

  31. Changes in fasting blood bilirubin

    Defined as the difference V3 (12 weeks) - V2 (baseline) in µmol/L

    Time frame: 12 weeks

  32. Changes in fasting blood bilirubin

    Defined as the difference V5 (26 weeks) - V4 (14 weeks) in µmol/L

    Time frame: 26 weeks

  33. Changes in fasting blood urea

    Defined as the difference V3 (12 weeks) - V2 (baseline) in mg/dL

    Time frame: 12 weeks

  34. Changes in fasting blood urea

    Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mg/dL

    Time frame: 26 weeks

  35. Changes in heart rate

    Defined as the difference V3 (12 weeks) - V2 (baseline) in bpm

    Time frame: 12 weeks

  36. Changes in heart rate

    Defined as the difference V5 (26 weeks) - V4 (14 weeks) in bpm

    Time frame: 26 weeks

  37. Changes in SBP (systolic blood pressure) and DBP (diastolic blood pressure)

    Defined as the difference V3 (12 weeks) - V2 (baseline) in mmHg (mean of the two measures for each parameter at each visit)

    Time frame: 12 weeks

  38. Changes in SBP (systolic blood pressure) and DBP (diastolic blood pressure)

    Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmHg (mean of the two measures for each parameter at each visit)

    Time frame: 26 weeks

  39. Changes in cardiac function (electrocardiogram, ECG)

    Defined as the difference V3 (12 weeks) - V2 (baseline)

    Time frame: 12 weeks

  40. Changes in cardiac function (electrocardiogram, ECG)

    Defined as the difference V5 (26 weeks) - V4 (14 weeks)

    Time frame: 26 weeks

  41. Changes in body weight

    Defined as the difference V3 (12 weeks) - V2 (baseline) in kg

    Time frame: 12 weeks

  42. Changes in body weight

    Defined as the difference V5 (26 weeks) - V4 (14 weeks) in kg

    Time frame: 26 weeks

  43. Changes in WC (waist circumference)

    Defined as the difference V3 (12 weeks) - V2 (baseline)

    Time frame: 12 weeks

  44. Changes in WC (waist circumference)

    Defined as the difference V5 (26 weeks) - V4 (14 weeks)

    Time frame: 26 weeks

  45. Changes in HC (hip circumference)

    Defined as the difference V3 (12 weeks) - V2 (baseline)

    Time frame: 12 weeks

  46. Changes in HC (hip circumference)

    Defined as the difference V5 (26 weeks) - V4 (14 weeks)

    Time frame: 26 weeks

  47. Changes in WHR (waist to hip ratio)

    Defined as the difference V3 (12 weeks) - V2 (baseline)

    Time frame: 12 weeks

  48. Changes in WHR (waist to hip ratio)

    Defined as the difference V5 (26 weeks) - V4 (14 weeks)

    Time frame: 26 weeks

  49. Changes in body composition

    Defined as the difference V3 (12 weeks) - V2 (baseline), using bioelectric impendence analysis

    Time frame: 12 weeks

  50. Changes in body composition

    Defined as the difference V5 (26 weeks) - V4 (14 weeks), using bioelectric impendence analysis

    Time frame: 26 weeks

Secondary outcomes

  1. Changes in fasting blood adiponectin

    Defined as the difference V5 (26 weeks) - V4 (14 weeks)

    Time frame: 26 weeks

  2. Changes in fasting blood leptin

    Defined as the difference V5 (26 weeks) - V4 (14 weeks)

    Time frame: 26 weeks

  3. Changes in the evolution of glycemia during an oral glucid tolerance test

    Changes between V5 (26 weeks) and V4 (14 weeks) visits (defined as the difference V4-V3 in mmol/L) of glycemia at 15, 30, 45, 60, 90 and 120 minutes between T0 and T120 minutes following a standard breakfast and considering the following time-points: T-10, T-5, T0, T15, T30, T45, T60, T90 and T120

    Time frame: 26 weeks

  4. Changes in the incremental area under the curve (glycemia response) during an oral glucid tolerance test

    Changes between V5 (26 weeks) and V4 (14 weeks) visits (defined as the difference V4-V3 in mmol/L) of incremental Area Under the Curve (iAUC) of glycemia between T0 and T120 minutes following a standard breakfast (iAUC0-120min) and considering the following time-points: T-10, T-5, T0, T15, T30, T45, T60, T90 and T120

    Time frame: 26 weeks

  5. Changes in the glycemia Cmax during an oral glucid tolerance test

    Changes between V5 (26 weeks) and V4 (14 weeks) visits (defined as the difference V4-V3 in mUIl/L) of glycemia Cmax between T0 and T120 minutes following a standard breakfast and considering the following time-points: T-10, T-5, T0, T15, T30, T45, T60, T90 and T120

    Time frame: 26 weeks

  6. Changes in the glycemia Δpeak during an oral glucid tolerance test

    Changes between V5 (26 weeks) and V4 (14 weeks) visits (defined as the difference V4-V3 in mmol/L) of Δpeak (difference from the baseline at Cmax), between T0 and T120 minutes following a standard breakfast and considering the following time-points: T-10, T-5, T0, T15, T30, T45, T60, T90 and T120

    Time frame: 26 weeks

  7. Changes in the evolution of insulinemia during an oral glucid tolerance test

    Changes between V5 (26 weeks) and V4 (14 weeks) visits (defined as the difference V4-V3 in mUI/L) of insulinemia at 15, 30, 45, 60, 90 and 120 minutes between T0 and T120 minutes following a standard breakfast and considering the following time-points: T-10, T-5, T0, T15, T30, T45, T60, T90 and T120

    Time frame: 26 weeks

  8. Changes in the incremental area under the curve (insulinemia response) during an oral glucid tolerance test

    Changes between V5 (26 weeks) and V4 (14 weeks) visits (defined as the difference V4-V3 in mUI/L) of incremental Area Under the Curve (iAUC) of insulinemia between T0 and T120 minutes following a standard breakfast (iAUC0-120min) and considering the following time-points: T-10, T-5, T0, T15, T30, T45, T60, T90 and T120

    Time frame: 26 weeks

  9. Changes in the insulinemia Cmax during an oral glucid tolerance test

    Changes between V5 (26 weeks) and V4 (14 weeks) visits (defined as the difference V4-V3 in mUIl/L) of insulinemia Cmax between T0 and T120 minutes following a standard breakfast and considering the following time-points: T-10, T-5, T0, T15, T30, T45, T60, T90 and T120

    Time frame: 26 weeks

  10. Changes in the insulinemia Δpeak during an oral glucid tolerance test

    Changes between V5 (26 weeks) and V4 (14 weeks) visits (defined as the difference V4-V3 in mUIl/L) of Δpeak (difference from the baseline at Cmax), between T0 and T120 minutes following a standard breakfast and considering the following time-points: T-10, T-5, T0, T15, T30, T45, T60, T90 and T120

    Time frame: 26 weeks

Other outcomes

  1. Changes in stools microbiota

    Changes between V5 (26 weeks) and V4 (14 weeks)

    Time frame: 26 weeks

07

Study locations

1 site
  • Centre d'Investigation Clinique
    Clermont-Ferrand, 63000, France
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03052062
Lead sponsor
Valbiotis
Collaborators
University Hospital, Clermont-Ferrand, Université Blaise Pascal, Clermont-Ferrand, Biofortis Mérieux NutriSciences
Responsible party
Sponsor
First posted
Feb 14, 2017
Start date
Mar 2, 2017
Primary completion
Jul 3, 2018
Completion
Jul 3, 2018
Last update
Jul 6, 2018

Study contacts

Gisèle Pickering, MD, PhD
principal investigator · Centre d'Investigation Clinique INSERM 501, Clermont-Ferrand, France
Sébastien Peltier, PhD
study director · Valbiotis

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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