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Prediabetic StateNCT05369585

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

A study testing TOTUM-63 in people with Prediabetic State and Dysglycemia, run by Valbiotis at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical study aims to investigate the effects of TOTUM-63, a mix of 5 plant extracts, consumed at the daily regimen of three times per day, on cardiometabolic health and gut microbiota profile in overweight-obese individuals. Read more about this study

Who is it for?
Ages 30 to 75 yearsHealthy volunteers can take part
What is being tested?
TOTUM-63
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
25 Apr 2022to 12 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Main Inclusion Criteria:

  • Body mass index (BMI) between ≥ 27 and < 40 kg/m2 kg/m²;
  • Waist circumference > 94 cm for men and > 80 cm for women;
  • Weight stable within ± 5% in the last three months;
  • Fasting plasma TG ≥ 1.35 OR fasting glycemia ≥ 5.6 and ≤ 6.9 mmol/L OR HbA1c ≥ 5.6 and ≤ 6.4 %

Main Exclusion Criteria:

  • Any metabolic disorder requiring pharmacological treatment and susceptible to affect glucose metabolism or plasma lipid levels or that might affect the study outcomes according to the investigator;
  • Taking medication which may affect the study outcomes (or a medication modification less than 3 months prior to the study);
  • To have taken regularly natural health products or enriched foods susceptible to modify the parameters followed by the investigator within the 3 months prior to the study;
  • With a known or suspected food allergy, intolerance or hypersensitivity to any of the study products' ingredient as well as the non-medicinal ingredients of the product;
  • Consuming more than 4 drinks of alcohol per week;
  • Having a lifestyle deemed incompatible with the study according to the investigator including high level of physical activity (defined as more than 10 hours of intense physical activity a week, walking excluded);
  • Pregnant or lactating women or intending to become pregnant within the timeframe of the study;
  • Fasting blood triglycerides (TG) > 2.5 mmol/L;
  • Fasting blood LDL-C > 4.9mmol/L or non-HDL-C > 5.7 mmol/L;
  • Blood AST ≥ 45 U/L for men; and blood AST ≥ 35 U/L for women;
  • Blood ALT ≥ 60 U/L for men; and blood ALT ≥ 50 U/L for women;
  • Blood GGT ≥ 75 U/L for men; and blood GGT ≥ 50 U/L for women;
  • Blood creatinine concentration > 125 μmol/L AND Estimated Glomerular Filtration Rate (eGFR) (calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula) < 60 mL/min/1.73m²;
  • Complete blood count (CBC) with hemoglobin < 120 g/L or leucocytes < 3000 /mm3 or leucocytes > 16000 /mm3 or clinically significant abnormality according to the investigator.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Institute of Nutrition and Funtional Foods (INAF) - Laval University

    Québec, G1V 0A6

Other trials in Canada

About this study

Official title: An Open-label, Single Arm, Clinical Trial to Explore the Consumption Effects of TOTUM-63 on Metabolic Signatures, Microbiome, Energy Metabolism and Post-prandial Nutrient Processing in Individuals at Increased Cardio-metabolic Risk

This clinical study aims to investigate the effects of TOTUM-63, a mix of 5 plant extracts, consumed at the daily regimen of three times per day, on cardiometabolic health and gut microbiota profile in overweight-obese individuals.

Read the detailed description

In 2019, over 460 million adults had diabetes worldwide. Moreover, it was estimated by the International Diabetes Federation that about 700 million adults will have type 2 diabetes (T2D) by 2045. Valbiotis is a research \& development company dedicated to scientific innovation for preventing and reducing the risk of metabolic and cardiovascular disease (CVD) using specific combinations of plant-based molecules. Valbiotis developed a formula (TOTUM-63) which is composed by the association of five plant extracts.

Given the results obtained in pre-clinical studies, as well as the good tolerance and first efficacy results of TOTUM-63 in two clinical trials on human subjects, this research aims to investigate the effects of TOTUM-63 on cardiometabolic health and gut microbiota profile in overweight-obese individuals. TOTUM-63 will be tested (5g acutely and 5g/d over 8 weeks of supplementation) on energy metabolism, post-prandial nutrients metabolism and hepatic health in overweight and obese subjects. Blood and feces samples collected before, and after the supplementation will allow to perform metabolomic, transcriptomic and metagenomics analyses to further explore the potential mechanisms of action of TOTUM-63.

Being tested
TOTUM-63
Keywords
Dysglycemia, Prediabetes, Diabetes risk, Cardio-metabolic risk, Diet supplement, Plant extracts, Polyphenols, Microbiota, Magnetic Resonance Imaging
Medical subject headings
Prediabetic State, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TOTUM-63Dietary supplement

    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.

Study groups in NCT05369585
Study groupRoleWhat they receive
TOTUM-63ExperimentalExperimental active are supplemented with TOTUM-63, taken 3 times per day.
Receives: Dietary Supplement: TOTUM-63

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evolution of blood pressure

    Systolic blood pressure, diastolic blood pressure (in mmHg)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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 %)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: Baseline and V3 (8 weeks of intervention)

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

    Whole metagenome shotgun sequencing

    Measured: Baseline and V3 (8 weeks of intervention)

  20. Evolution of metagenomic parameters (microbiota diversity)

    Microbiota diversity measurements (Shannon index)

    Measured: Baseline and V3 (8 weeks of intervention)

  21. Evolution of metagenomic parameters (microbiota richness)

    Microbiota richness measurements (Simpson index)

    Measured: Baseline and V3 (8 weeks of intervention)

  22. Evolution of liver MRI

    Liver fat content

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

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

Secondary outcomes (9)

  1. Evolution of Safety parameters (hepatic enzymes)

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

    Measured: 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

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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 %)

    Measured: 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

    Measured: 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)

    Measured: Baseline and V3 (8 weeks of intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2022
  2. Study start25 Apr 2022
  3. Primary completion12 Apr 2023
  4. Study completion12 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Open-label, single center, single arm
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05369585
Sponsor's protocol ID
2021-408
Other IDs
255926, 2021-408
Status last verified
May 2022
First submitted
5 Apr 2022
Last updated
13 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing TOTUM-63 in people with Prediabetic State and Dysglycemia, run by Valbiotis at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evolution of blood pressure (time frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05369585.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.

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