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Prediabetic StateREVERSE-ITNCT04423302

Effect of Totum-63 on Glucose and Lipid Homeostasis in Subjects With Dysglycemia (REVERSE-IT)

A study testing TOTUM-63 3 intakes per day and TOTUM-63 2 intakes per day in people with Prediabetic State and Diabetes type2, run by Valbiotis at 52 sites in 7 countries.

Completed

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

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Prediabetic State, Diabetes type2, Dysglycemia
What is being tested?
TOTUM-63 3 intakes per day and TOTUM-63 2 intakes per day
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
636 participants
Where
52 sitesin 7 countries
Study dates
8 Jul 2020to 23 Jun 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 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • I1. From 18 to 70 years (including ranges);
  • I2. Dysglycemic, prediabetic or newly diagnosed type 2 diabetes, subject without any clinical symptoms of diabetes (e.g. polyuria, polydipsia, blurred vision…) and not requiring immediate anti-diabetic treatment;
  • I3. Body mass index (BMI) between 25 and 40 kg/m² (including ranges);
  • I4. Waist circumference > 102 cm for men and > 88 cm for women (-2% margin allowed, respectively ≥ 100 cm and ≥ 86.5 cm);
  • I5. Weight stable within ± 5% in the last three months;
  • I6. No significant change in food habits or in physical activity in the 3 months before the randomization and agreeing to follow hygiene and dietary (HD) recommendations given during the study;
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  • I7. For women: Non-menopausal with the same reliable contraception since at least three months before the beginning of the study and agreeing to keep it during the entire duration of the study (hormonal contraception, intra uterine device or surgical intervention) or menopausal with or without hormone replacement therapy (estrogenic replacement therapy begun from less than 3 months excluded);
  • I8. Good general and mental health according to the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination;
  • I9. Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form;
  • I10. Affiliated with a social security scheme;
  • I11. Agreeing to be registered on the volunteers in biomedical research (applicable only for French centers).
  • At V0 biological analysis, the subjects will be eligible to the study on the following criteria:
  • I12. Fasting plasma glucose concentration ≥ 110 mg/dL.

Who cannot join

  • E1. Suffering from a metabolic disorder such as treated diabetes, uncontrolled thyroidal dysfunction or other metabolic disorder needing a dose adjustment in drug intervention according to the professional recommendations;
  • E2. Suffering from an uncontrolled arterial hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
  • E3. With a history of retinopathy, ischemic cardiovascular event, having undergone recent surgical procedure in the past 6 months or in the 9 months to come;
  • E4. Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, hepatic or biliary disorders ongoing, chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble, etc.) or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator (e.g. celiac disease);
  • E5. Under antidiabetic drug (e.g. biguanides, sulfonylureas, glinides, gliptins, glitazones, gliflozins, α-glucosidase inhibitors, incretins and insulin);
  • E6. Under lipid-lowering treatment (e.g. statins, fibrates, ezetimibe, bile acid sequestrants, niacin, etc.) since less than 3 months or modification of the treatment dose since less than 3 months before the randomization. Subject with a stable lipid-lowering treatment since at least three months can be included in the study;
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  • E7. Under medication which could affect glucose and/or lipid homeostasis parameters or stopped less than 3 months before randomization (e.g. beta 2 agonists like salbutamol, Angiotensin Converting Enzyme (ACE) inhibitors, beta blockers, thiazide diuretics, Selective Serotonin Reuptake Inhibitors (SSRIs), Mono-Amine Oxidase Inhibitors (MAOIs), neuroleptics, long-term corticosteroid systemic drugs, systemic antibodies, androgens, phenytoin, interferons, immunosuppressants, antivirals and antiretrovirals, etc.):
  • Beta 2 agonists like salbutamol, ACE inhibitors, beta blockers, thiazide diuretics, SSRIs, MAOIs are tolerated only if stable since more than 3 months before the randomization and maintained during the whole study;
  • The others drugs (neuroleptics, long-term corticosteroid systemic drugs, systemic antibodies, androgens, phenytoin, interferons, immunosuppressants, antivirals and antiretrovirals, etc.) are not allowed during the study;
  • E8. Regular intake of dietary supplements or "health foods", or products rich in plant stanol or sterol (like Pro-Activ® or Danacol® products), rich in long chain omega-3 fatty acids (especially soft gels containing fish oils), or in other substances intended to reduce glycemia (e.g. beta-glucans, konjac, olive leaf extract, berberine, cinnamon, etc.) or stopped less than 3 months before the randomization;
  • E9. Under treatment or dietary supplement which could significantly affect parameter(s) followed during the study according to the investigator or stopped in a too short period before the randomization (for example consumed in the month before the randomization);
  • E10. With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient;
  • E11. Consuming more than 3 standard drinks daily of alcoholic beverage for men or 2 standard drinks daily for women or not agreeing to keep his alcohol consumption habits unchanged throughout the study;
  • E12. With extreme and/or unbalanced eating habits (e.g. vegetarian, vegan, skipping meals regularly);
  • E13. With a personal history of anorexia nervosa, bulimia or significant eating disorders according to the investigator;
  • E14. Smoking more than 20 cigarettes daily or not agreeing to keep his smoking habits unchanged throughout the study. The subject should be able not to smoke during the visits (maximum 4 hours);
  • E15. 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);
  • E16. Pregnant (as evidenced by a positive test for β-HCG (Human Chorionic Gonadotropin), i.e. > 5 mUI/mL, realized at V0) or lactating women or intending to become pregnant within 9 months ahead;
  • E17. Who made a blood donation in the 3 months before the randomization or intending to make it within 9 months ahead;
  • E18. Taking part in another clinical trial or being in the exclusion period of a previous clinical trial;
  • E19. Having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros (applicable only for French centers);
  • E20. Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision;
  • E21. Presenting a psychological or linguistic incapability to sign the informed consent;
  • E22. Impossible to contact in case of emergency;
  • E23. Any condition assessed by the investigator which could endanger patient safety or the conduct of the study (e.g. device related contraindication for impedancemetry and/or DEXA (Dual-Energy X-ray Absorptiometry) such as pacemaker or electronic implant);
  • At V0 biological analysis, the subjects will be considered as non-eligible to the study on the following criteria:
  • E24. Fasting glucose plasma concentration > 220 mg/dL;
  • E25. Fasting blood triglycerides > 2.2 g/L;
  • E26. TSH (Thyroid Stimulating Hormone) outside the laboratory normal values;
  • E27. Fasting blood LDL (Low Density Lipoprotein) cholesterol > 1.9 g/L or non HDLc (High Density Lipoprotein cholesterol) > 2.2 g/L or any condition requiring a therapeutic dose adjustment during the trial according to the professional recommendations;
  • E28. Blood AST (ASpartate amino Transferase), ALT (ALanine amino Transferase) or GGT (Gamma Glutamyl Transpeptidase) > 3 x ULN (Upper Limit of Normal);
  • E29. Blood creatinine concentration > 125 μmol/L;
  • E30. eGFR estimated Glomerular Filtration Rate, calculated by CKD-EPI (Chronic Kidney Disease-EPIdemiology collaboration) formula) < 60 mL/min/1.73m²;
  • E31. Complete blood count (CBC) with hemoglobin < 11 g/dL or leucocytes < 3000 /mm3 or leucocytes > 16000 /mm3 or clinically significant abnormality according to the investigator.

Trial locations and contacts

52 sites in 7 countries.

52 sites in 7 countries

France14 sites

  • CHU Amiens

    Amiens, 80054

  • CH Arras

    Arras, 62000

  • CIC Clermont Ferrand

    Clermont-Ferrand, 63000

  • CEN Nutriment

    Dijon, 21000

  • Eurofins Optimed

    Gières, 38610

  • CHU Grenoble

    Grenoble, 38043

  • Institut Pasteur de Lille

    Lille, 59019

  • CHU Lille

    Lille, 59037

  • CHU Nantes

    Nantes, 44093

  • CHU Nice

    Nice, 06202

  • Unité d'Investigation Clinique Biofortis Mérieux NutriSciences

    Paris, 75012

  • Unité de Recherche Clinique en Immunologie Lyon Sud

    Pierre-Bénite, 69310

  • CHU Rouen

    Rouen, 76000

  • Biofortis Mérieux NutriSciences

    Saint-Herblain, 44800

Other trials in France

Germany11 sites

  • Analyze & Realize

    Berlin, 13467

  • Klinische Forschung Dresden

    Dresden, 01069

  • Medizentrum Essen Borbeck

    Essen, 45355

  • Biotesys

    Esslingen am Neckar, 73728

  • Klinische Forschung Hamburg

    Hamburg, 20253

  • Klinische Forschung Hannover-Mitte

    Hanover, 30159

  • Klinische Forschung Karlsruhe

    Karlsruhe, 76137

  • Gemeinschaftspraxis Dr. Med C. Klein/J Minnich

    Künzing

  • Zentrum fur Klinische Studien

    Sankt Ingbert

  • Klinische Forschung Schwerin

    Schwerin, 19055

  • Zentrum für Klinische Ernährung Stuttgart

    Stuttgart, 70599

Other trials in Germany

Bulgaria8 sites

  • MHAT-Botevgrad EOOD, Botevgrad

    Botevgrad

  • MHAT Sveta Karidad, First department of Internal Diseases

    Plovdiv, 4004

  • Ambulatory for IPSOC in Endocrynology and Metabolic Diseases ENDO MED-CONSULT EOOD

    Plovdiv

  • Diagnostic-consultative center 7 EOOD, Plovdiv

    Plovdiv

  • Diagnostic Consultative Center "ALEXANDROVSKA"

    Sofia, 1431

  • University Multiprofile Hospital for active treatment "Alexandrovska" EAD Clinic of Endocrinology and metabolic diseases

    Sofia, 1431

  • 4th Multiprofile Hospital for active treatment - EAD, Internal Diseases Departement

    Sofia, 1606

  • Diagnostic Consultative Center

    Sofia

Other trials in Bulgaria

Hungary8 sites

  • Drug Resesarch Center (DRC)

    Balatonfüred, 8230

  • Trial Pharma Ltd

    Békéscsaba, 5600

  • ClinExpert Medical Center

    Budapest, 1033

  • Agria - Study Ltd

    Eger, 3300

  • Trial Pharma Ltd

    Győr, 9000

  • Trial Pharma Ltd

    Gyula, 5703

  • Clinical Research Unit (CRU)

    Miskolc, 3529

  • Trial Pharma Ltd

    Orosháza, 5900

Other trials in Hungary

Italy4 sites

  • Azienda Ospedaliera Universitaria "Mater Domini"

    Catanzaro, 88100

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"

    Palermo, 90127

  • Policlinico Umberto I

    Roma, 00161

Other trials in Italy

Romania4 sites

  • Sana Monitoring

    Bucharest

  • Ames Research Cente

    Calarasi

  • Spitalul Municipal Caracal

    Caracal

  • Clintrial Medical Center

    Reșca

Other trials in Romania

Poland3 sites

  • Vitamed

    Bydgoszcz

  • Grupowa Praktyka Lekarska s.c

    Katowice

  • Centrum Medyczne Linden

    Krakow

Other trials in Poland

About this study

Official title: Randomized Placebo-controlled Double-blinded Study of the Effect of TOTUM-63 on Glucose and Lipid Homeostasis in Subjects With Dysglycemia

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.

Being tested
TOTUM-63 3 intakes per day, Placebo 3 intakes per day, TOTUM-63 2 intakes per day
Keywords
Dysglycemia, Prediabetes, Type 2 diabetes, Hyperglycemia, Insulinemia, Diabetes risk, Diet supplement, Plant extracts, Health condition, Hygiene and dietary recommendations, Diet
Medical subject headings
Prediabetic State, Diabetes Mellitus, Type 2, Hyperglycemia

What participants receive

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

  • TOTUM-63 3 intakes per dayDietary supplement

    Also called Active product 3 intakes per day

    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 3 intakes per dayDietary supplement

    Also called Comparator product 3 intakes per day

    Placebo. Eight capsules per day to consume orally in three intakes (3 in the morning, 2 at lunch and 3 at dinner)

  • TOTUM-63 2 intakes per dayDietary supplement

    Also called Active product 2 intakes per day

    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)

Study groups in NCT04423302
Study groupRoleWhat they receive
TOTUM-63 3 intakes per dayExperimentalExperimental active diet supplement TOTUM-63 taken 3 times per day (blinded arm)
Receives: Dietary Supplement: TOTUM-63 3 intakes per day
Placebo 3 intakes per dayPlacebo comparatorPlacebo comparator taken 3 times per day (blinded arm)
Receives: Dietary Supplement: Placebo 3 intakes per day
TOTUM-63 2 intakes per dayExperimentalExperimental active diet supplement TOTUM-63 taken 2 times per day (open arm)
Receives: Dietary Supplement: TOTUM-63 2 intakes per day

What is being measured

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

  1. 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

    Measured: V3 (24 weeks of intervention)

Secondary outcomes (25)

  1. 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

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  2. 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

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  3. 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)

    Measured: V1 (baseline), V2 (12 weeks of intervention), V3 (24 weeks of intervention) and V4 (12 weeks and the end of intervention)

  4. 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

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  5. 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

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  6. 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

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  7. 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

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  8. 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

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  9. 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

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  10. 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

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  11. 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

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  12. 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

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  13. 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

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  14. 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

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  15. 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

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  16. 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

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  17. 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

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  18. 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

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  19. 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

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  20. 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

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  21. 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

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  22. 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

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  23. 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

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  24. 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

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  25. 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

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 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 posted9 Jun 2020
  2. Study start8 Jul 2020
  3. Primary completion31 Jan 2023
  4. Study completion23 Jun 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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
636 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04423302
Sponsor's protocol ID
PEC16075
Other IDs
2020-A00604-35
Acronym
REVERSE-IT
Status last verified
Sep 2023
First submitted
28 May 2020
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chavanelle V, F Otero Y, Fayat Cazaubiel M, Bard JM, Pereira B, Sapone V, Bouchard-Mercier A, Bargetto M, Boisseau N, Guigas B, Peltier S, Le Joubioux F, Maugard T, Hadjadj S, Sirvent P, Marette A. Totum-63, a plant-based polyphenol-rich extract, in prediabetes or early-stage type 2 diabetes: an international, multicenter, randomized controlled trial. Nat Commun. 2026 Jul 20. doi: 10.1038/s41467-026-75626-0. Online ahead of print.

    PubMed 42477326

Questions about this trial

What is this clinical trial studying?

A study testing TOTUM-63 3 intakes per day and TOTUM-63 2 intakes per day in people with Prediabetic State and Diabetes type2, run by Valbiotis at 52 sites in 7 countries.

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

Who may be eligible to take part?

The sponsor lists 13 inclusion and 34 exclusion criteria. 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in France, Germany, Bulgaria, Hungary, Italy and 2 more countries. 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. Some participants in this study may receive a placebo. 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?

Fasting plasma glucose concentration at V3 with a 3 times a day regimen (time frame: V3 (24 weeks of intervention)). 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 NCT04423302, which also lists 1 linked publication.

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 21 Sep 2023.

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