Mode of Action (MoA) Study of TOTUM-63 in Individuals at Increased Cardio-metabolic Risk

Browse trials for

• Prediabetic State 1,021
• Overweight 3,771
• Obesity 6,578

Keywords

• Dysglycemia
• Prediabetes
• Diabetes risk
• Cardio-metabolic risk
• Diet supplement
• Plant extracts
• Polyphenols
• Microbiota
• Magnetic Resonance Imaging

Prediabetic State

1,021 studies on the registry are indexed under Prediabetic State; 242 are open to participants now.

This study's enrollment of 20 is below the median of 66 across 861 interventional studies indexed under Prediabetic State.

Lead sponsor

Valbiotis is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Eligibility criteria

Study arms

• Experimental
  TOTUM-63

  Experimental active are supplemented with TOTUM-63, taken 3 times per day.

  Dietary Supplement: TOTUM-63

Interventions

• Dietary supplementTOTUM-63

  5-g per day dose of TOTUM-63 supplement, a mix of 5 plant extracts. Daily dose for 8 weeks followed by a 4 weeks follow-up period without supplementation.

Primary outcomes

1. Evolution of blood pressure

   Systolic blood pressure, diastolic blood pressure (in mmHg)

   Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

2. Evolution of heart rate

   Heart rate (in BPM)

   Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

3. Evolution of weight

   Weight (in kg)

   Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

4. Evolution of waist circumference

   Waist circumference (in cm)

   Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

5. Evolution of body mass index

   Body mass index (in kg/m2)

   Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

6. Evolution of fasting glycemia

   Fasting glycemia (in mmol/L)

   Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

7. Evolution of insulin secretion

   Fasting insulinemia and C-peptide (in pmol/L)

   Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

8. Evolution of HbA1c

   Fasting HbA1c (in %)

   Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

9. Evolution of satiety hormones

   Peptide tyrosine tyrosine (PYY), cholecystokinin (in pg/ml)

   Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

10. Evolution of adipokines

    Adiponectin, leptin, plasminogen activator inhibitor 1 (in ng/ml)

    Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

11. Evolution of inflammatory response (fibrinogen)

    Fibrinogen (in ng/ml)

    Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

12. Evolution of inflammatory response (IL6, TNFa)

    Interleukin 6, tumour necrosis factor alpha (in pg/ml)

    Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

13. Evolution of inflammatory response (hs-CRP)

    High-sensitivity C-reactive protein (in mg/L)

    Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

14. Evolution of incretin response

    Glucose-dependent insulinotropic polypeptide, glucagon-like peptide-1 (in pg/ml)

    Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

15. Evolution of blood lipid profile (lipid profile)

    Triglycerides, total cholesterol, HDL-C, non-HDL-C, LDL-C, free-fatty-acids (in mmol/L)

    Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

16. Evolution of blood lipid profile (oxidized-LDL)

    Oxidized-LDL (in ng/ml)

    Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

17. Evolution of blood lipid profile (ketones)

    Ketones (in umol/L)

    Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

18. Evolution of fecal and plasma bile acid profiles

    Primary and secondary bile acids profiles (fecal and plasma) (in uM)

    Time frame: Baseline and V3 (8 weeks of intervention)

19. Evolution of metagenomic parameters (whole metagenome shotgun sequencing)

    Whole metagenome shotgun sequencing

    Time frame: Baseline and V3 (8 weeks of intervention)

20. Evolution of metagenomic parameters (microbiota diversity)

    Microbiota diversity measurements (Shannon index)

    Time frame: Baseline and V3 (8 weeks of intervention)

21. Evolution of metagenomic parameters (microbiota richness)

    Microbiota richness measurements (Simpson index)

    Time frame: Baseline and V3 (8 weeks of intervention)

22. Evolution of liver MRI

    Liver fat content

    Time frame: Baseline and V3 (8 weeks of intervention)

23. Evolution of FIB-4 index

    FIB-4 index (FIB-4 index \< 1.45 in the context of steatosis allows the exclusion of a clinically significant fibrosis)

    Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

24. Evolution of BARD score

    BARD score (from 0 to 4, with a score of 4 resulting in a higher risk of advanced fibrosis)

    Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

25. Evolution of NAFLD fibrosis score

    NAFLD fibrosis score (\< -1.455 low fibrosis probability; -1.455 to 0.676 intermediate score; \> 0.676 high probability of fibrosis)

    Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

26. Evolution in kinetics of glucose metabolism

    Evaluation of glucose concentrations during a 6-hours mixed-meal tolerance test (in mmol/L)

    Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

27. Evolution in kinetics of insulin secretion

    Evaluation of blood insulin and C-peptide during a 6-hours mixed-meal tolerance test (in pmol/L)

    Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

28. Evolution in kinetics of blood lipid profile

    Evaluation of triglycerides, total cholesterol, HDL-C, non-HDL-C and LDL-C during a 6-hours mixed-meal tolerance test (in mmol/L)

    Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

29. Evolution of kinetics of incretin parameters

    Evaluation of glucose-dependent insulinotropic polypeptide, glucagon-like peptide-1 during a 2-hours mixed-meal tolerance test (in pg/ml)

    Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

30. Evolution of inflammatory parameters (fibrinogen)

    Evaluation of fibrinogen before and after a 6-hours mixed-meal tolerance test (in ng/ml)

    Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

31. Evolution of inflammatory parameters (IL6, TNFA)

    Evaluation of interleukin 6, tumour necrosis factor alpha before and after a 6-hours mixed-meal tolerance test (in pg/ml)

    Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

32. Evolution of inflammatory parameters (hs-CRP)

    Evaluation high-sensitivity C-reactive protein before and after a 6-hours mixed-meal tolerance test (in mg/L)

    Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

33. Evolution of energy metabolism (respiratory quotient)

    Evaluation of respiratory quotient before and after a 6-hours mixed-meal tolerance test (in carbon dioxide (CO2) eliminated / dioxygen (O2) consumed)

    Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

34. Evolution of energy metabolism (resting metabolic rate)

    Evaluation of resting metabolic rate before and after a 6-hours mixed-meal tolerance test (in kcal/day)

    Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

35. Evolution of energy metabolism (energy expenditure)

    Evaluation of energy expenditure before and after a 6-hours mixed-meal tolerance test (in kcal/kg/h)

    Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Secondary outcomes

1. Evolution of Safety parameters (hepatic enzymes)

   Aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltransferase (GGT) (in U/L)

   Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

2. Evolution of Safety parameters (AST/ALT ratio)

   AST/ALT ratio

   Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

3. Evolution of Safety parameters (albumin)

   Albumin (in g/L)

   Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

4. Evolution of Safety parameters (creatinine)

   Creatinine (in umol/L)

   Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

5. Evolution of complete blood count (red and white blood cells, platelet)

   Red blood cells, white blood cells, platelet (in cells/mm3)

   Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

6. Evolution of complete blood count (hemoglobin)

   Hemoglobin (in g/L)

   Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

7. Evolution of complete blood count (hematocrit)

   Hematocrit (in %)

   Time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

8. Evolution of transcriptomics

   RNA sequencing

   Time frame: Baseline and V3 (8 weeks of intervention)

9. Evolution of metabolomics (amino acids, fatty acids and acylcarnitine species)

   Evolution of amino acids, fatty acids and acylcarnitine species (in uM)

   Time frame: Baseline and V3 (8 weeks of intervention)

Individual participant data

Plan to share: No