This clinical study aims to assess the efficacy of TOTUM-63, a mix of 5 plant extracts, consumed at the daily regimen of three times per day on glucose and lipid homeostasis in dysglycemic subjects. The hypothesis is that TOTUM-63, consumed 3 times per day, is superior to placebo for decrease of fasting plasma glucose (FPG) concentration after 24 weeks of consumption.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
636
5-g dose of TOTUM-63 diet supplement, a mix of 5 plant extracts. Eight capsules per day to consume orally in three intakes (3 in the morning, 2 at lunch and 3 at dinner)
Placebo. Eight capsules per day to consume orally in three intakes (3 in the morning, 2 at lunch and 3 at dinner)
5-g dose of TOTUM-63 diet supplement, a mix of 5 plant extracts. Eight capsules per day to consume orally in two intakes (4 in the morning and 4 at dinner)
Fasting plasma glucose concentration at V3 with a 3 times a day regimen
Fasting plasma glucose concentration in mg/dL, TOTUM-63 3/day vs placebo
Time frame: V3 (24 weeks of intervention)
Evolution of the fasting plasma glucose concentration
Fasting plasma glucose concentration (in mg/dL), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the HbA1c
HbA1c (in %), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the glycemia at 120 minutes following the 75g glucose intake
Glycemia (in mg/dL) at 120 minutes following the 75g glucose intake, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo (Only for a subgroup of 201 subjects)
Time frame: V1 (baseline), V2 (12 weeks of intervention), V3 (24 weeks of intervention) and V4 (12 weeks and the end of intervention)
Evolution of the fasting insulinemia
Fasting insulinemia (in mU/L), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the HOMA-IR (HOmeostasis Model Assessment of Insulin Resistance) index
HOMA-IR index, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
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MHAT-Botevgrad EOOD, Botevgrad
Botevgrad, Bulgaria
MHAT Sveta Karidad, First department of Internal Diseases
Plovdiv, Bulgaria
Ambulatory for IPSOC in Endocrynology and Metabolic Diseases ENDO MED-CONSULT EOOD
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Diagnostic-consultative center 7 EOOD, Plovdiv
Plovdiv, Bulgaria
Diagnostic Consultative Center "ALEXANDROVSKA"
Sofia, Bulgaria
University Multiprofile Hospital for active treatment "Alexandrovska" EAD Clinic of Endocrinology and metabolic diseases
Sofia, Bulgaria
4th Multiprofile Hospital for active treatment - EAD, Internal Diseases Departement
Sofia, Bulgaria
Diagnostic Consultative Center
Sofia, Bulgaria
CHU Amiens
Amiens, France
CH Arras
Arras, France
...and 42 more locations
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the HOMA-β (Homeostasis Model Assessment of Beta cells) index
HOMA-β index, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the QUICKY (QUantitative Insulin sensitivity ChecK Index) index
QUICKY index, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the fasting blood concentrations of triglycerides
Triglycerides (in g/L), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the fasting blood concentrations of total cholesterol
Total cholesterol (in g/L), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the fasting blood concentrations of HDL cholesterol
HDL cholesterol (in g/L), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the fasting blood concentrations of non-HDL cholesterol
non-HDL cholesterol (in g/L), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the fasting blood concentrations of LDL cholesterol
LDL cholesterol (in g/L), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the fasting blood concentrations of free fatty acids
Free fatty acids (in g/L), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of atherogenic index
Atherogenic index, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of atherogenic coefficient
Atherogenic coefficient, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of Cardiac risk ratio 1
Cardiac risk ratio 1, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of cardiac risk ratio 2
Cardiac risk ratio 2, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the fasting blood concentrations of hsCRP
hsCRP (in mg/L), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the body weight
Body weight (in kg), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the waist circumference
Waist circumference (in cm), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the hip circumference
Hip circumference (in cm), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the waist to hip ratio
Waist to hip ratio, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Evolution of the body composition assessed by impedancemeter
Fat mass (in % and kg), lean mass (in % and kg), total body water (in % and kg), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Delay of occurence of pharmacological treatment requirement for type 2 diabetes from V1
Delay between V1 and the date at which the investigator will decide to withdraw the subject from the study because he needs a pharmacological treatment to treat his diabetes, TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
Proportion of subjects having an improvement or a deterioration of their glycemic status from V1
Glycemic status will be defined at each visit by the FPG value, 3 different categories Type 2 diabetes/prediabetic/normal. Proportion of subjects changing from category during the study will be assessed during the study (improvement of the glycemic status or deterioration), TOTUM-63 3/day vs placebo, TOTUM-63 2/day vs placebo and TOTUM-63 3/day pooled with TOTUM-63 2/day vs placebo
Time frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)