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

Valbiotis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Obese

Treatments: Dietary Supplement: Lipidrive

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03052062

2016-A01187-44

Details and patient eligibility

About

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

Full 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).

Enrollment: 20 patients

Sex: Male

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Lipidrive

Experimental group

Description:

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

Treatment:

Dietary Supplement: Lipidrive