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

Obese Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03052062
• Other study ID #: 2016-A01187-44
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2, 2017
• Est. completion date: July 3, 2018

Study information

• Verified date: July 2018
• Source: Valbiotis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 3, 2018
• Est. primary completion date: July 3, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 65 Years

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Obese

Intervention

Dietary Supplement:
• Lipidrive
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

Locations

Country	Name	City	State
France	Centre d'Investigation Clinique	Clermont-Ferrand

Sponsors (4)

Lead Sponsor	Collaborator
Valbiotis	Biofortis Mérieux NutriSciences, Université Blaise Pascal, Clermont-Ferrand, University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in stools microbiota	Changes between V5 (26 weeks) and V4 (14 weeks)	26 weeks
Primary	Changes in fasting blood glucose	Defined as the difference V3 (12 weeks) - V2 (baseline) in mmol/L	12 weeks
Primary	Changes in fasting blood glucose	Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L	26 weeks
Primary	Changes in fasting insulinemia	Defined as the difference V3 (12 weeks) - V2 (baseline)) in mUI/L	12 weeks
Primary	Changes in fasting insulinemia	Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mUI/L	26 weeks
Primary	Changes in fasting HOMA-IR	Defined as the difference V3 (12 weeks) - V2 (baseline)	12 weeks
Primary	Changes in fasting HOMA-IR	Defined as the difference V5 (26 weeks) - V4 (14 weeks)	26 weeks
Primary	Changes in glycated hemoglobin	Defined as the difference V3 (12 weeks) - V2 (baseline) in %	12 weeks
Primary	Changes in glycated hemoglobin	Defined as the difference V5 (26 weeks) - V4 (14 weeks) in %	26 weeks
Primary	Changes in fasting fructosamin	Defined as the difference V3 (12 weeks) - V2 (baseline) in µmol/L	12 weeks
Primary	Changes in fasting fructosamin	Defined as the difference V5 (26 weeks) - V4 (14 weeks) in µmol/L	26 weeks
Primary	Changes in fasting total cholesterol	Defined as the difference V3 (12 weeks) - V2 (baseline) in mmol/L	12 weeks
Primary	Changes in fasting total cholesterol	Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L	26 weeks
Primary	Changes in fasting HDL cholesterol	Defined as the difference V3 (12 weeks) - V2 (baseline) in mmol/L	12 weeks
Primary	Changes in fasting HDL cholesterol	Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L	26 weeks
Primary	Changes in fasting LDL cholesterol	Defined as the difference V3 (12 weeks) - V2 (baseline) in mmol/L	12 weeks
Primary	Changes in fasting LDL cholesterol	Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L	26 weeks
Primary	Changes in fasting triglycerides	Defined as the difference V3 (12 weeks) - V2 (baseline) in mmol/L	12 weeks
Primary	Changes in fasting triglycerides	Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L	26 weeks
Primary	Changes in oxidized LDL	Defined as the difference V3 (12 weeks) - V2 (baseline) in mmol/L	12 weeks
Primary	Changes in oxidized LDL	Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L	26 weeks
Primary	Changes in us-CRP	Defined as the difference V3 (12 weeks) - V2 (baseline) in mg/L	12 weeks
Primary	Changes in us-CRP	Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L	26 weeks
Primary	Changes in blood creatinine	Defined as the difference V3 (12 weeks) - V2 (baseline) in mg/dL	12 weeks
Primary	Changes in blood creatinine	Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mg/dL	26 weeks
Primary	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	12 weeks
Primary	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	26 weeks
Primary	Changes in fasting blood levels of GGT (Gamma glutamyltransferase)	Defined as the difference V3 (12 weeks) - V2 (baseline) in UI/L	12 weeks
Primary	Changes in fasting blood levels of GGT (Gamma glutamyltransferase)	Defined as the difference V5 (26 weeks) - V4 (14 weeks) in UI/L	26 weeks
Primary	Changes in fasting alkaline phosphatase	Defined as the difference V3 (12 weeks) - V2 (baseline) in UI/L	12 weeks
Primary	Changes in fasting alkaline phosphatase	Defined as the difference V5 (26 weeks) - V4 (14 weeks) in UI/L	26 weeks
Primary	Changes in fasting blood bilirubin	Defined as the difference V3 (12 weeks) - V2 (baseline) in µmol/L	12 weeks
Primary	Changes in fasting blood bilirubin	Defined as the difference V5 (26 weeks) - V4 (14 weeks) in µmol/L	26 weeks
Primary	Changes in fasting blood urea	Defined as the difference V3 (12 weeks) - V2 (baseline) in mg/dL	12 weeks
Primary	Changes in fasting blood urea	Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mg/dL	26 weeks
Primary	Changes in heart rate	Defined as the difference V3 (12 weeks) - V2 (baseline) in bpm	12 weeks
Primary	Changes in heart rate	Defined as the difference V5 (26 weeks) - V4 (14 weeks) in bpm	26 weeks
Primary	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)	12 weeks
Primary	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)	26 weeks
Primary	Changes in cardiac function (electrocardiogram, ECG)	Defined as the difference V3 (12 weeks) - V2 (baseline)	12 weeks
Primary	Changes in cardiac function (electrocardiogram, ECG)	Defined as the difference V5 (26 weeks) - V4 (14 weeks)	26 weeks
Primary	Changes in body weight	Defined as the difference V3 (12 weeks) - V2 (baseline) in kg	12 weeks
Primary	Changes in body weight	Defined as the difference V5 (26 weeks) - V4 (14 weeks) in kg	26 weeks
Primary	Changes in WC (waist circumference)	Defined as the difference V3 (12 weeks) - V2 (baseline)	12 weeks
Primary	Changes in WC (waist circumference)	Defined as the difference V5 (26 weeks) - V4 (14 weeks)	26 weeks
Primary	Changes in HC (hip circumference)	Defined as the difference V3 (12 weeks) - V2 (baseline)	12 weeks
Primary	Changes in HC (hip circumference)	Defined as the difference V5 (26 weeks) - V4 (14 weeks)	26 weeks
Primary	Changes in WHR (waist to hip ratio)	Defined as the difference V3 (12 weeks) - V2 (baseline)	12 weeks
Primary	Changes in WHR (waist to hip ratio)	Defined as the difference V5 (26 weeks) - V4 (14 weeks)	26 weeks
Primary	Changes in body composition	Defined as the difference V3 (12 weeks) - V2 (baseline), using bioelectric impendence analysis	12 weeks
Primary	Changes in body composition	Defined as the difference V5 (26 weeks) - V4 (14 weeks), using bioelectric impendence analysis	26 weeks
Secondary	Changes in fasting blood adiponectin	Defined as the difference V5 (26 weeks) - V4 (14 weeks)	26 weeks
Secondary	Changes in fasting blood leptin	Defined as the difference V5 (26 weeks) - V4 (14 weeks)	26 weeks
Secondary	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	26 weeks
Secondary	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	26 weeks
Secondary	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	26 weeks
Secondary	Changes in the glycemia ?peak 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 ?peak (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	26 weeks
Secondary	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	26 weeks
Secondary	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	26 weeks
Secondary	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	26 weeks
Secondary	Changes in the insulinemia ?peak 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 ?peak (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	26 weeks