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

NCT03052062 | Completed Phase 1 DMC

• 1 other identifier: 2016-A01187-44
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Obese

Outcome Measures

Primary Outcomes (50)

• Changes in fasting blood glucose

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

  12 weeks

• Changes in fasting blood glucose

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

  26 weeks

• Changes in fasting insulinemia

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

  12 weeks

• Changes in fasting insulinemia

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

  26 weeks

• Changes in fasting HOMA-IR

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

  12 weeks

• Changes in fasting HOMA-IR

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

  26 weeks

• Changes in glycated hemoglobin

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

  12 weeks

• Changes in glycated hemoglobin

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

  26 weeks

• Changes in fasting fructosamin

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

  12 weeks

• Changes in fasting fructosamin

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

  26 weeks

• Changes in fasting total cholesterol

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

  12 weeks

• Changes in fasting total cholesterol

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

  26 weeks

• Changes in fasting HDL cholesterol

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

  12 weeks

• Changes in fasting HDL cholesterol

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

  26 weeks

• Changes in fasting LDL cholesterol

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

  12 weeks

• Changes in fasting LDL cholesterol

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

  26 weeks

• Changes in fasting triglycerides

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

  12 weeks

• Changes in fasting triglycerides

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

  26 weeks

• Changes in oxidized LDL

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

  12 weeks

• Changes in oxidized LDL

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

  26 weeks

• Changes in us-CRP

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

  12 weeks

• Changes in us-CRP

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

  26 weeks

• Changes in blood creatinine

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

  12 weeks

• Changes in blood creatinine

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

  26 weeks

• 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

• 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

• Changes in fasting blood levels of GGT (Gamma glutamyltransferase)

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

  12 weeks

• Changes in fasting blood levels of GGT (Gamma glutamyltransferase)

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

  26 weeks

• Changes in fasting alkaline phosphatase

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

  12 weeks

• Changes in fasting alkaline phosphatase

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

  26 weeks

• Changes in fasting blood bilirubin

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

  12 weeks

• Changes in fasting blood bilirubin

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

  26 weeks

• Changes in fasting blood urea

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

  12 weeks

• Changes in fasting blood urea

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

  26 weeks

• Changes in heart rate

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

  12 weeks

• Changes in heart rate

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

  26 weeks

• 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

• 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

• Changes in cardiac function (electrocardiogram, ECG)

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

  12 weeks

• Changes in cardiac function (electrocardiogram, ECG)

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

  26 weeks

• Changes in body weight

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

  12 weeks

• Changes in body weight

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

  26 weeks

• Changes in WC (waist circumference)

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

  12 weeks

• Changes in WC (waist circumference)

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

  26 weeks

• Changes in HC (hip circumference)

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

  12 weeks

• Changes in HC (hip circumference)

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

  26 weeks

• Changes in WHR (waist to hip ratio)

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

  12 weeks

• Changes in WHR (waist to hip ratio)

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

  26 weeks

• Changes in body composition

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

  12 weeks

• Changes in body composition

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

  26 weeks

Secondary Outcomes (10)

• Changes in fasting blood adiponectin

  26 weeks

• Changes in fasting blood leptin

  26 weeks

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

  26 weeks

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

  26 weeks

• Changes in the glycemia Cmax during an oral glucid tolerance test

  26 weeks

Other Outcomes (1)

• Changes in stools microbiota

  26 weeks

Study Arms (1)

Lipidrive

EXPERIMENTAL

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

Lipidrive DIETARY_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

Lipidrive

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• ≤ Creatinine ≤ 104 μmol/L (± 10%)

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Valbiotis: lead
• University Hospital, Clermont-Ferrand: collaborator
• Université Blaise Pascal, Clermont-Ferrand: collaborator
• Biofortis Mérieux NutriSciences: collaborator

Study Sites (1)

Centre d'Investigation Clinique

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gisèle Pickering, MD, PhD

  Centre d'Investigation Clinique INSERM 501, Clermont-Ferrand, France

  PRINCIPAL INVESTIGATOR

• Sébastien Peltier, PhD

  Valbiotis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 14, 2017
• Study Start: March 2, 2017
• Primary Completion: July 3, 2018
• Study Completion: July 3, 2018
• Last Updated: July 6, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)