Clinical trial NCT03052062: Tolerance Study of the Dietary Supplement Lipidrive (ECPH1-03)
Official title: Lipidrive Dietary Supplement Tolerance Study Based on Blood, Urine, and Hemodynamic Biological Parameters.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Obese
Lead sponsor: Valbiotis
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Clermont-Ferrand
name: Université Blaise Pascal, Clermont-Ferrand
name: Biofortis Mérieux NutriSciences
First posted: 2017-02-14
Enrollment: 20
Sex: MALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

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).

Eligibility criteria: 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

Primary outcomes:
measure: Changes in fasting blood glucose
timeFrame: 12 weeks
measure: Changes in fasting blood glucose
timeFrame: 26 weeks
measure: Changes in fasting insulinemia
timeFrame: 12 weeks
measure: Changes in fasting insulinemia
timeFrame: 26 weeks
measure: Changes in fasting HOMA-IR
timeFrame: 12 weeks
measure: Changes in fasting HOMA-IR
timeFrame: 26 weeks
measure: Changes in glycated hemoglobin
timeFrame: 12 weeks
measure: Changes in glycated hemoglobin
timeFrame: 26 weeks
measure: Changes in fasting fructosamin
timeFrame: 12 weeks
measure: Changes in fasting fructosamin
timeFrame: 26 weeks
measure: Changes in fasting total cholesterol
timeFrame: 12 weeks
measure: Changes in fasting total cholesterol
timeFrame: 26 weeks
measure: Changes in fasting HDL cholesterol
timeFrame: 12 weeks
measure: Changes in fasting HDL cholesterol
timeFrame: 26 weeks
measure: Changes in fasting LDL cholesterol
timeFrame: 12 weeks
measure: Changes in fasting LDL cholesterol
timeFrame: 26 weeks
measure: Changes in fasting triglycerides
timeFrame: 12 weeks
measure: Changes in fasting triglycerides
timeFrame: 26 weeks
measure: Changes in oxidized LDL
timeFrame: 12 weeks
measure: Changes in oxidized LDL
timeFrame: 26 weeks
measure: Changes in us-CRP
timeFrame: 12 weeks
measure: Changes in us-CRP
timeFrame: 26 weeks
measure: Changes in blood creatinine
timeFrame: 12 weeks
measure: Changes in blood creatinine
timeFrame: 26 weeks
measure: Changes in fasting blood levels of ASAT (Aspartate aminotransferase) and ALAT (Alanine aminotransferase)
timeFrame: 12 weeks
measure: Changes in fasting blood levels of ASAT (Aspartate aminotransferase) and ALAT (Alanine aminotransferase)
timeFrame: 26 weeks
measure: Changes in fasting blood levels of GGT (Gamma glutamyltransferase)
timeFrame: 12 weeks
measure: Changes in fasting blood levels of GGT (Gamma glutamyltransferase)
timeFrame: 26 weeks
measure: Changes in fasting alkaline phosphatase
timeFrame: 12 weeks
measure: Changes in fasting alkaline phosphatase
timeFrame: 26 weeks
measure: Changes in fasting blood bilirubin
timeFrame: 12 weeks
measure: Changes in fasting blood bilirubin
timeFrame: 26 weeks
measure: Changes in fasting blood urea
timeFrame: 12 weeks
measure: Changes in fasting blood urea
timeFrame: 26 weeks
measure: Changes in heart rate
timeFrame: 12 weeks
measure: Changes in heart rate
timeFrame: 26 weeks
measure: Changes in SBP (systolic blood pressure) and DBP (diastolic blood pressure)
timeFrame: 12 weeks
measure: Changes in SBP (systolic blood pressure) and DBP (diastolic blood pressure)
timeFrame: 26 weeks
measure: Changes in cardiac function (electrocardiogram, ECG)
timeFrame: 12 weeks
measure: Changes in cardiac function (electrocardiogram, ECG)
timeFrame: 26 weeks
measure: Changes in body weight
timeFrame: 12 weeks
measure: Changes in body weight
timeFrame: 26 weeks
measure: Changes in WC (waist circumference)
timeFrame: 12 weeks
measure: Changes in WC (waist circumference)
timeFrame: 26 weeks
measure: Changes in HC (hip circumference)
timeFrame: 12 weeks
measure: Changes in HC (hip circumference)
timeFrame: 26 weeks
measure: Changes in WHR (waist to hip ratio)
timeFrame: 12 weeks
measure: Changes in WHR (waist to hip ratio)
timeFrame: 26 weeks
measure: Changes in body composition
timeFrame: 12 weeks
measure: Changes in body composition
timeFrame: 26 weeks
Secondary outcomes:
measure: Changes in fasting blood adiponectin
timeFrame: 26 weeks
measure: Changes in fasting blood leptin
timeFrame: 26 weeks
measure: Changes in the evolution of glycemia during an oral glucid tolerance test
timeFrame: 26 weeks
measure: Changes in the incremental area under the curve (glycemia response) during an oral glucid tolerance test
timeFrame: 26 weeks
measure: Changes in the glycemia Cmax during an oral glucid tolerance test
timeFrame: 26 weeks
measure: Changes in the glycemia Δpeak during an oral glucid tolerance test
timeFrame: 26 weeks
measure: Changes in the evolution of insulinemia during an oral glucid tolerance test
timeFrame: 26 weeks
measure: Changes in the incremental area under the curve (insulinemia response) during an oral glucid tolerance test
timeFrame: 26 weeks
measure: Changes in the insulinemia Cmax during an oral glucid tolerance test
timeFrame: 26 weeks
measure: Changes in the insulinemia Δpeak during an oral glucid tolerance test
timeFrame: 26 weeks
Other outcomes:
measure: Changes in stools microbiota
timeFrame: 26 weeks
Locations:
city: Clermont-Ferrand
country: France
facility: Centre d'Investigation Clinique
Study officials:
affiliation: Centre d'Investigation Clinique INSERM 501, Clermont-Ferrand, France
name: Gisèle Pickering, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Valbiotis
name: Sébastien Peltier, PhD
role: STUDY_DIRECTOR
References: