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ObesePhase 1/2NCT03052062

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

A Phase 1/2 study testing Lipidrive in people with Obese, run by Valbiotis at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 45 to 65 years, men only
Conditions the study is for
Obese
What is being tested?
Lipidrive
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteFrance
Study dates
2 Mar 2017to 3 Jul 2018
Phase
Phase 1/2
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 45 to 65 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 19Show fewer
  • 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%).

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre d'Investigation Clinique

    Clermont-Ferrand, 63000

Other trials in France

About this study

Official title: Lipidrive Dietary Supplement Tolerance Study Based on Blood, Urine, and Hemodynamic Biological Parameters.

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).

Conditions
Obese
Being tested
Lipidrive
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LipidriveDietary supplement

    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

Study groups in NCT03052062
Study groupRoleWhat they receive
LipidriveExperimentalDose 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
Receives: Dietary Supplement: Lipidrive

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in fasting blood glucose

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

    Measured: 12 weeks

  2. Changes in fasting blood glucose

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

    Measured: 26 weeks

  3. Changes in fasting insulinemia

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

    Measured: 12 weeks

  4. Changes in fasting insulinemia

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

    Measured: 26 weeks

  5. Changes in fasting HOMA-IR

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

    Measured: 12 weeks

  6. Changes in fasting HOMA-IR

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

    Measured: 26 weeks

  7. Changes in glycated hemoglobin

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

    Measured: 12 weeks

  8. Changes in glycated hemoglobin

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

    Measured: 26 weeks

  9. Changes in fasting fructosamin

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

    Measured: 12 weeks

  10. Changes in fasting fructosamin

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

    Measured: 26 weeks

  11. Changes in fasting total cholesterol

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

    Measured: 12 weeks

  12. Changes in fasting total cholesterol

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

    Measured: 26 weeks

  13. Changes in fasting HDL cholesterol

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

    Measured: 12 weeks

  14. Changes in fasting HDL cholesterol

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

    Measured: 26 weeks

  15. Changes in fasting LDL cholesterol

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

    Measured: 12 weeks

  16. Changes in fasting LDL cholesterol

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

    Measured: 26 weeks

  17. Changes in fasting triglycerides

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

    Measured: 12 weeks

  18. Changes in fasting triglycerides

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

    Measured: 26 weeks

  19. Changes in oxidized LDL

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

    Measured: 12 weeks

  20. Changes in oxidized LDL

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

    Measured: 26 weeks

  21. Changes in us-CRP

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

    Measured: 12 weeks

  22. Changes in us-CRP

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

    Measured: 26 weeks

  23. Changes in blood creatinine

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

    Measured: 12 weeks

  24. Changes in blood creatinine

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

    Measured: 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

    Measured: 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

    Measured: 26 weeks

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

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

    Measured: 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

    Measured: 26 weeks

  29. Changes in fasting alkaline phosphatase

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

    Measured: 12 weeks

  30. Changes in fasting alkaline phosphatase

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

    Measured: 26 weeks

  31. Changes in fasting blood bilirubin

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

    Measured: 12 weeks

  32. Changes in fasting blood bilirubin

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

    Measured: 26 weeks

  33. Changes in fasting blood urea

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

    Measured: 12 weeks

  34. Changes in fasting blood urea

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

    Measured: 26 weeks

  35. Changes in heart rate

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

    Measured: 12 weeks

  36. Changes in heart rate

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

    Measured: 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)

    Measured: 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)

    Measured: 26 weeks

  39. Changes in cardiac function (electrocardiogram, ECG)

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

    Measured: 12 weeks

  40. Changes in cardiac function (electrocardiogram, ECG)

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

    Measured: 26 weeks

  41. Changes in body weight

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

    Measured: 12 weeks

  42. Changes in body weight

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

    Measured: 26 weeks

  43. Changes in WC (waist circumference)

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

    Measured: 12 weeks

  44. Changes in WC (waist circumference)

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

    Measured: 26 weeks

  45. Changes in HC (hip circumference)

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

    Measured: 12 weeks

  46. Changes in HC (hip circumference)

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

    Measured: 26 weeks

  47. Changes in WHR (waist to hip ratio)

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

    Measured: 12 weeks

  48. Changes in WHR (waist to hip ratio)

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

    Measured: 26 weeks

  49. Changes in body composition

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

    Measured: 12 weeks

  50. Changes in body composition

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

    Measured: 26 weeks

Secondary outcomes (10)

  1. Changes in fasting blood adiponectin

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

    Measured: 26 weeks

  2. Changes in fasting blood leptin

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2017
  2. Study start2 Mar 2017
  3. Primary completion3 Jul 2018
  4. Study completion3 Jul 2018

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03052062
Sponsor's protocol ID
2016-A01187-44
Status last verified
Jul 2018
First submitted
7 Feb 2017
Last updated
6 Jul 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lipidrive in people with Obese, run by Valbiotis at 1 site in France.

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 19 inclusion and 19 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 6 Jul 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 France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Changes in fasting blood glucose (time frame: 12 weeks). The study lists 50 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03052062.

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 6 Jul 2018.

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