PrediabetesPhase 2/3TOTUM-63 TWONCT02868177
Effect of Totum-63, Active Ingredient of Valedia, on Glucose and Lipid Homeostasis on Subjects With Prediabetes
A Phase 2/3 study testing Totum-63 in people with Prediabetes and Type 2 Diabetes, run by Valbiotis at 6 sites in 4 countries.
Trial summary
Given the data on the active ingredients of Totum-63, this research aims to evaluate the effect of its chronic consumption (24 weeks) on glucose and lipid homeostasis and especially on fasting plasma glucose in volunteers with abdominal obesity associated with impaired glucose tolerance or untreated type 2 diabetes… Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes, Type 2 Diabetes, Hypertriglyceridemia
- What is being tested?
- Totum-63
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Oct 2016to Apr 2019
- Phase
- Phase 2/3
- 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 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- I1. Fasting glycemia > 6,1 mmol/L. (1,1 g/L). I2. 2 hours glycemia (OGTT) > 7,8 mmol/L (1,4 g/L). I3. HbA1c < 7% I4. Triglyceridemia > 1,5 g/L. I5. Prediabetic or type-2 diabetic but not requiring immediate drug therapy according to the current recommendations (HAS, 2013).
- I6. Waist circumference > 94 cm for men or > 80 cm for women. I7. With reported body weight variation < 5% in the 3 months prior the randomization.
- I8. Without significant change in food habits or in physical activity in the 3 months before randomization and agreeing to keep them unchanged throughout the study (no hyper-hypocaloric diet nor start-stop of sport activity planned in the next 7 months).
- I9. 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 (oestrogenic replacement therapy begun from less than 3 months excluded).
- I10. Good general and mental health with in the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination.
- I11. Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form.
- I12. Affiliated with a social security scheme. I13. Agree to be registered on the volunteers in biomedical research file.
Who cannot join
- E1. Fasting blood triglycerides > 3,5 g/L. E2. TSH outside the laboratory normal values. E3. Fasting blood TC > 4,5 g/L or HDLc < 0,1 g/L with an abnormality judged as clinically significant according to the investigator.
- E4. Blood AST, ALT or GGT > 3xULN (laboratory Upper Limit of Normal). E5. Blood urea > 12 mmol/L or creatinine > 125 µmol/L. E6. Complete blood count with hemoglobin < 11 g/L or leucocytes < 3000 / mm3 or leucocytes > 16000 / mm3 or clinically significant abnormality according to the investigator.
- E7. Suffering from a metabolic disorder such as treated diabetes, uncontrolled thyroidal trouble or other metabolic disorder.
- E8. Suffering from an uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg).
- E9. With a history of retinopathy, microalbuminuria, ischemic cardiovascular event or, during the previous 6 months a surgical procedure.
- E10. 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).
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- E11. Under antidiabetic drug (e.g. biguanides, sulfonylureas, glinides, gliptines, glitazones, gliflozines, α-glucosidase inhibitors, incretins and insulin).
- E12. Under lipid-lowering treatment (e.g. statins, fibrates, ezetimibe, bile acid sequestrants, niacin, etc.) or stopped less than 3 months before the randomization.
- E13. Requiring cholesterol lowering by immediate pharmacologic intervention according to the current recommendations (AFSSAPS 2005).
- E14. Under medication which could affect glucose and/or lipid homeostasis parameters or stopped less than 3 months before randomization (e.g. beta 2 agoniste 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 agoniste like salbutamol, ACE inhibitors, beta blockers, thiazide diuretics, SSIRs, MAOIs begun more than 3 months before the randomization and maintained stable during the whole study are tolerated. 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.
- E15. Regular intake of dietary supplements or "health foods" rich in plant stanol or sterol (like PRO-ACTIV or DANACOL products), in long chain omega-3 fatty acids (especially sofgels containing fish oils), or in other substances intended to lower LDLc, TG or glycemia (e.g. beta-glucans, konjac, cinnamon, olive leaf extract, berberine, red yeast rice, policosanol, etc.) or stopped less than 3 months before the randomization.
- E16. 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.
- E17. Under dietary supplement in the month before V1. E18. With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient.
- E19. Consuming more than 3 standard drinks 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.
- E20. With extreme eating habits (e.g. vegetarian or vegan). E21. With a personal history of anorexia nervosa, bulimia or significant eating disorders according to the investigator.
- E22. Smoking more than 10 cigarettes daily or not agreeing to keep his smoking habits unchanged throughout the study.
- E23. Having a lifestyle deemed incompatible with the study according to the investigator including high level physical activity (defined as more than 10 hours of significant physical activity a week, walking excluded).
- E24. Pregnant or lactating women or intending to become pregnant within 7 months ahead.
- E25. Who made a blood donation in the 3 months before the randomization or intending to make it within 7 months ahead.
- E26. Taking part in another clinical trial or being in the exclusion period of a previous clinical trial.
- E27. Having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros.
- E28. Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision.
- E29. Presenting a psychological or linguistic incapability to sign the informed consent.
- E30. Impossible to contact in case of emergency.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
France2 sites
Institut Pasteur de Lille
Lille, 59019
Biofortis Mérieux NutriSciences Clinical Investigation Center
Saint-Herblain, 44800
Serbia2 sites
Clinical center of Kragujevac, / Poseidon CRO
Kragujevac
Clinical Center of Vojvodina / Poseidon CRO
Novi Sad, 21000
About this study
Official title: Totum-63 Effect on Glucose and Lipid Homeostasis in People With Abdominal Obesity Associated With Impaired Glucose Tolerance or Untreated Type 2 Diabetes and Hypertriglyceridemia
Given the data on the active ingredients of Totum-63, this research aims to evaluate the effect of its chronic consumption (24 weeks) on glucose and lipid homeostasis and especially on fasting plasma glucose in volunteers with abdominal obesity associated with impaired glucose tolerance or untreated type 2 diabetes and hypertriglyceridemia. This clinical study is designed to estimate the effect of Totum-63, active ingredient of Valedia, on several glucose and lipid homeostasis related parameters since these data are still unknown for this specific dietary supplement formula. Collected data will provide more reliable information which may be used to plan a subsequent larger main study.
Read the detailed description
Primary objective:
The primary objective of the present trial is to assess the beneficial effect of Totum-63 compared to a placebo on glucose homeostasis assessed by the fasting plasma glucose level in prediabetics or untreated type 2 diabetics after 24 weeks of consumption.
Secondary objectives:
Secondary objectives of the study are to assess the efficacy of Totum-63 compared to a placebo in prediabetics or untreated type 2 diabetics after 12 and 24 weeks of consumption through the following criteria:
- Glucose homeostasis assessed by fasting plasma glucose level (after 12 weeks of consumption only), fasting blood HbA1c and fructosamine levels, OGTT (Oral Glucose Tolerance Test after 24 weeks of consumption only), insulinemic and glycemic parameters.
- Pancreatic beta-cells function and insulin sensitivity assessed by fasting blood insulin level, HOMA-IR (Homeostasis Model Assessment of Insulin Resistance), HOMA-β, QUICKI (Quantitative Insulin sensitivity Check Index), ISI-M (Matsuda-DeFronzo Insulin Sensitivity Index after 24 weeks of consumption only), OGIS (Oral Glucose Insulin Sensitivity after 24 weeks of consumption only) and PREDIM (PREDIcted M after 24 weeks of consumption only) indexes.
- Lipid homeostasis assessed by fasting blood levels of triglycerides (TG), Total Cholesterol (TC), HDL-cholesterol, LDL-cholesterol and NEFA (Non-Esterified Fatty Acids).
- Oxidation mechanism of circulating lipids assessed by the ratio fasting blood LDLox / fasting blood LDLc and the PON-1 (paraoxonase-1, arylesterase activity) activity in blood.
- Low grade inflammation assessed by fasting blood hsCRP level.
- Hepatic function assessed by fasting blood total bilirubin level, GGT, ASAT and ALAT activities in blood.
- Hemodynamics assessed by Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP).
- Anthropometrics assessed by Body Weight (BW), Waist Circumference (WC), Hip Circumference (HC) and Waist to Hip Ratio (WHR).
- Satiety assessed by the three-day food diary energy and nutrient intake parameters.
Safety objectives:
The following criteria assessed after 24 weeks of study product consumption participate to the objectives of safety check:
- Renal function assessed by fasting blood creatinine and urea level;
- Complete blood count.
- Conditions
- Prediabetes, Type 2 Diabetes, Hypertriglyceridemia, Obesity, Disease, Insulin Resistance
- Being tested
- Totum-63, Placebo
- Keywords
- Prevention
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2, Hypertriglyceridemia, Obesity, Disease, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Totum-63Dietary supplement
Each randomized subject will consume 8 capsules daily of either active (5200 mg of Totum-63) during 24 weeks (from visit V1 to visit V3). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner.
PlaceboDietary supplement
Each randomized subject will consume 8 capsules daily of placebo (5064 mg of maltodextrine) during 24 weeks (from visit V1 to visit V3). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner.
| Study group | Role | What they receive |
|---|---|---|
| Totum-63 | Experimental | The studied active product is a food supplement formula in shape of capsule which contains Totum-63 (a patented mixture of dry extracts from 5 plants), active ingredient of Valedia Receives: Dietary Supplement: Totum-63 |
| Placebo | Placebo comparator | The comparative product is a placebo with the same characteristics of appearance and packaging in which all ingredients are replaced by maltodextrin. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in fasting glycemia
Defined as the difference V3 (24 weeks) - V1 (baseline) in g/L
Measured: 24 weeks
Secondary outcomes (36)
Changes in fasting glycemia
Defined as the difference V2 (12 weeks) - V1 (baseline) in g/L
Measured: 12 weeks
Changes in fasting blood levels of HbA1c
Defined as the difference V3 (24 weeks) - V1 (baseline) in %
Measured: 24 weeks
Changes in fasting blood levels of HbA1c
Defined as the difference V2 (12 weeks) - V1 (baseline) in %
Measured: 12 weeks
Changes in fasting blood levels of fructosamine
Defined as the difference V3 (24 weeks) - V1 (baseline) in µmol/L
Measured: 24 weeks
Changes in fasting blood levels of fructosamine
Defined as the difference V2 (12 weeks) - V1 (baseline) in µmol/L
Measured: 12 weeks
Changes in fasting insulinemia
Defined as the difference V3 (24 weeks) - V1 (baseline) in mU/L
Measured: 24 weeks
Changes in fasting insulinemia
Defined as the difference V2 (12 weeks) - V1 (baseline) in mU/L
Measured: 12 weeks
Changes in the evolution of glycemia during an oral glucose tolerance test
Changes between V1 (baseline) and V3 (24 weeks) visits (defined as the difference V3-V1 in g/L) of glycemia at 30, 60, 90 and 120 minutes, glucose Cmax and Δpeak (difference from the baseline at Cmax) and Incremental Area Under the Curve (iAUC) of glycemia between T0 and T120 minutes following the 75g glucose intake (iAUC0-120min) and considering the following time-points: T0, T30, T60, T90 and T120
Measured: 24 weeks
Changes in the evolution of insulinemia during an oral glucose tolerance test
Changes between V1 (baseline) and V3 (24 weeks) visits (defined as the difference V3-V1 in g/L) of insulinemia at 30, 60, 90 and 120 minutes, insulin Cmax and Δpeak (difference from the baseline at Cmax) and Incremental Area Under the Curve (iAUC) of insulinemia between T0 and T120 minutes following the 75 g glucose intake (iAUC0-120min) and considering the following time-points: T0, T30, T60, T90 and T120
Measured: 24 weeks
Changes in HOMA-IR, HOMA-β, QUICKI, ISI-M, OGIS and PREDIM indices
Defined as the difference V3 (24 weeks) - V1 (baseline)
Measured: 24 weeks
Changes in HOMA-IR, HOMA-β and QUICKI indices
Defined as the difference V2 (12 weeks) - V1 (baseline)
Measured: 12 weeks
Changes in fasting blood concentrations of triglycerides, non esterified fatty acids, LDL cholesterol, HDL cholesterol and Total cholesterol
Defined as the difference V3 (24 weeks) - V1 (baseline) in g/L
Measured: 24 weeks
Changes in fasting blood concentrations of triglycerides, non esterified fatty acids, LDL cholesterol, HDL cholesterol and Total cholesterol
Defined as the difference V2 (12 weeks) - V1 (baseline) in g/L
Measured: 12 weeks
Changes in fasting blood level of PON-1 (Paraoxonase)
Defined as the difference V3 (24 weeks) - V1 (baseline) in μkat/L
Measured: 24 weeks
Changes in fasting blood level of PON-1 (Paraoxonase)
Defined as the difference V2 (12 weeks) - V1 (baseline) in μkat/L
Measured: 12 weeks
Changes in the ratio of fasting blood oxidized LDL / fasting blood LDL cholesterol
Defined as the difference V3 (24 weeks) - V1 (baseline) in U/g
Measured: 24 weeks
Changes in the ratio of fasting blood oxidized LDL / fasting blood LDL cholesterol
Defined as the difference V2 (12 weeks) - V1 (baseline) in U/g
Measured: 12 weeks
Changes in fasting blood level of hsCRP
Defined as the difference V3 (24 weeks) - V1 (baseline) in mg/L
Measured: 24 weeks
Changes in fasting blood level of hsCRP
Defined as the difference V2 (12 weeks) - V1 (baseline) in mg/L
Measured: 12 weeks
Changes in fasting blood levels of ASAT (Aspartate aminotransferase) and ALAT (Alanine aminotransferase)
Defined as the difference V3 (24 weeks) - V1 (baseline) in µkat/L
Measured: 24 weeks
Changes in fasting blood levels of GGT (Gamma glutamyltransferase)
Defined as the difference V3 (24 weeks) - V1 (baseline) in µkat/L
Measured: 24 weeks
Changes in fasting blood levels of bilirubin
Defined as the difference V3 (24 weeks) - V1 (baseline) in µmol/L
Measured: 24 weeks
Changes in fasting blood levels of creatinine
Defined as the difference V3 (24 weeks) - V1 (baseline) in µmol/L
Measured: 24 weeks
Changes in fasting blood levels of creatinine
Defined as the difference V2 (12 weeks) - V1 (baseline) in µmol/L
Measured: 12 weeks
Changes in heart rate
Defined as the difference V3 (24 weeks) - V1 (baseline) in bpm
Measured: 24 weeks
Changes in heart rate
Defined as the difference V2 (12 weeks) - V1 (baseline) in bpm
Measured: 12 weeks
Changes in SBP (systolic blood pressure) and DBP (diastolic blood pressure)
Defined as the difference V3 (24 weeks) - V1 (baseline) in mmHg (mean of the two measures for each parameter at each visit)
Measured: 24 weeks
Changes in SBP (systolic blood pressure) and DBP (diastolic blood pressure)
Defined as the difference V2 (12 weeks) - V1 (baseline) in mmHg (mean of the two measures for each parameter at each visit)
Measured: 12 weeks
Changes in body weight
Defined as the difference V3 (24 weeks) - V1 (baseline) in kg
Measured: 24 weeks
Changes in body weight
Defined as the difference V2 (12 weeks) - V1 (baseline) in kg
Measured: 12 weeks
Changes in WC (waist circumference)
Defined as the difference V3 (24 weeks) - V1 (baseline) in cm
Measured: 24 weeks
Changes in WC (waist circumference)
Defined as the difference V2 (12 weeks) - V1 (baseline) in cm
Measured: 12 weeks
Changes in HC (hip circumference)
Defined as the difference V3 (24 weeks) - V1 (baseline) in cm
Measured: 24 weeks
Changes in HP (hip circumference)
Defined as the difference V2 (12 weeks) - V1 (baseline) in cm
Measured: 12 weeks
Changes in WHR (waist to hip ratio)
Defined as the difference V3 (24 weeks) - V1 (baseline)
Measured: 24 weeks
Changes in WHR (waist to hip ratio)
Defined as the difference V2 (12 weeks) - V1 (baseline)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valbiotis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Mérieux NutriSciences, Institut Pasteur de Lille
- Responsible party
- Sponsor
- Investigators
- David GENDRE, Dr, Principal investigator, Biofortis Mérieux NutriSciencesSébastien L PELTIER, PhD, Study director, ValbiotisJean-Marie BARD, Dr-PhD, Study chair, UFR des Sciences Pharmaceutiques et Biologiques, Nantes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868177
- Sponsor's protocol ID
- 2016-A00484-47
- Acronym
- TOTUM-63 TWO
- Status last verified
- Oct 2020
- First submitted
- 11 Aug 2016
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Totum-63 Effect on Glucose and Lipid Homeostasis in People With Abdominal Obesity Associated With Impaired Glucose Tolerance or Untreated Type 2 Diabetes and Hypertriglyceridemia
- ClinicalTrials.gov ID
- NCT02868177
- Acronym / sponsor ID
- TOTUM-63 TWO / 2016-A00484-47
- Conditions
- Prediabetes, Type 2 Diabetes, Hypertriglyceridemia, Obesity, Disease, Insulin Resistance
- Keywords
- Prevention
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- ValbiotisIndustry (pharma, biotech, devices)
- Collaborators
- Biofortis Mérieux NutriSciences, Institut Pasteur de Lille
- Study start
- Oct 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Given the data on the active ingredients of Totum-63, this research aims to evaluate the effect of its chronic consumption (24 weeks) on glucose and lipid homeostasis and especially on fasting plasma glucose in volunteers with abdominal obesity associated with impaired glucose tolerance or untreated type 2 diabetes and hypertriglyceridemia. This clinical study is designed to estimate the effect of Totum-63, active ingredient of Valedia, on several glucose and lipid homeostasis related parameters since these data are still unknown for this specific dietary supplement formula. Collected data will provide more reliable information which may be used to plan a subsequent larger main study.
Detailed description
Primary objective:
The primary objective of the present trial is to assess the beneficial effect of Totum-63 compared to a placebo on glucose homeostasis assessed by the fasting plasma glucose level in prediabetics or untreated type 2 diabetics after 24 weeks of consumption.
Secondary objectives:
Secondary objectives of the study are to assess the efficacy of Totum-63 compared to a placebo in prediabetics or untreated type 2 diabetics after 12 and 24 weeks of consumption through the following criteria:
- Glucose homeostasis assessed by fasting plasma glucose level (after 12 weeks of consumption only), fasting blood HbA1c and fructosamine levels, OGTT (Oral Glucose Tolerance Test after 24 weeks of consumption only), insulinemic and glycemic parameters.
- Pancreatic beta-cells function and insulin sensitivity assessed by fasting blood insulin level, HOMA-IR (Homeostasis Model Assessment of Insulin Resistance), HOMA-β, QUICKI (Quantitative Insulin sensitivity Check Index), ISI-M (Matsuda-DeFronzo Insulin Sensitivity Index after 24 weeks of consumption only), OGIS (Oral Glucose Insulin Sensitivity after 24 weeks of consumption only) and PREDIM (PREDIcted M after 24 weeks of consumption only) indexes.
- Lipid homeostasis assessed by fasting blood levels of triglycerides (TG), Total Cholesterol (TC), HDL-cholesterol, LDL-cholesterol and NEFA (Non-Esterified Fatty Acids).
- Oxidation mechanism of circulating lipids assessed by the ratio fasting blood LDLox / fasting blood LDLc and the PON-1 (paraoxonase-1, arylesterase activity) activity in blood.
- Low grade inflammation assessed by fasting blood hsCRP level.
- Hepatic function assessed by fasting blood total bilirubin level, GGT, ASAT and ALAT activities in blood.
- Hemodynamics assessed by Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP).
- Anthropometrics assessed by Body Weight (BW), Waist Circumference (WC), Hip Circumference (HC) and Waist to Hip Ratio (WHR).
- Satiety assessed by the three-day food diary energy and nutrient intake parameters.
Safety objectives:
The following criteria assessed after 24 weeks of study product consumption participate to the objectives of safety check:
- Renal function assessed by fasting blood creatinine and urea level;
- Complete blood count.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Totum-63 | Experimental | Dietary Supplement: Totum-63The studied active product is a food supplement formula in shape of capsule which contains Totum-63 (a patented mixture of dry extracts from 5 plants), active ingredient of Valedia |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe comparative product is a placebo with the same characteristics of appearance and packaging in which all ingredients are replaced by maltodextrin. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- I1. Fasting glycemia > 6,1 mmol/L. (1,1 g/L). I2. 2 hours glycemia (OGTT) > 7,8 mmol/L (1,4 g/L). I3. HbA1c < 7% I4. Triglyceridemia > 1,5 g/L. I5. Prediabetic or type-2 diabetic but not requiring immediate drug therapy according to the current recommendations (HAS, 2013).
- I6. Waist circumference > 94 cm for men or > 80 cm for women. I7. With reported body weight variation < 5% in the 3 months prior the randomization.
- I8. Without significant change in food habits or in physical activity in the 3 months before randomization and agreeing to keep them unchanged throughout the study (no hyper-hypocaloric diet nor start-stop of sport activity planned in the next 7 months).
- I9. 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 (oestrogenic replacement therapy begun from less than 3 months excluded).
- I10. Good general and mental health with in the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination.
Key exclusion criteria (24 listed)
- E1. Fasting blood triglycerides > 3,5 g/L. E2. TSH outside the laboratory normal values. E3. Fasting blood TC > 4,5 g/L or HDLc < 0,1 g/L with an abnormality judged as clinically significant according to the investigator.
- E4. Blood AST, ALT or GGT > 3xULN (laboratory Upper Limit of Normal). E5. Blood urea > 12 mmol/L or creatinine > 125 µmol/L. E6. Complete blood count with hemoglobin < 11 g/L or leucocytes < 3000 / mm3 or leucocytes > 16000 / mm3 or clinically significant abnormality according to the investigator.
- E7. Suffering from a metabolic disorder such as treated diabetes, uncontrolled thyroidal trouble or other metabolic disorder.
- E8. Suffering from an uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg).
- E9. With a history of retinopathy, microalbuminuria, ischemic cardiovascular event or, during the previous 6 months a surgical procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Totum-63Each randomized subject will consume 8 capsules daily of either active (5200 mg of Totum-63) during 24 weeks (from visit V1 to visit V3). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner. | Dietary supplement | Totum-63 |
| PlaceboEach randomized subject will consume 8 capsules daily of placebo (5064 mg of maltodextrine) during 24 weeks (from visit V1 to visit V3). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner. | Dietary supplement | Placebo |
Primary outcome
Changes in fasting glycemia
Time frame: 24 weeks
Defined as the difference V3 (24 weeks) - V1 (baseline) in g/L
36 secondary outcomes
Changes in fasting glycemia
Time frame: 12 weeks
Changes in fasting blood levels of HbA1c
Time frame: 24 weeks
Changes in fasting blood levels of HbA1c
Time frame: 12 weeks
Changes in fasting blood levels of fructosamine
Time frame: 24 weeks
Changes in fasting blood levels of fructosamine
Time frame: 12 weeks
Changes in fasting insulinemia
Time frame: 24 weeks
Changes in fasting insulinemia
Time frame: 12 weeks
Changes in the evolution of glycemia during an oral glucose tolerance test
Time frame: 24 weeks
Changes in the evolution of insulinemia during an oral glucose tolerance test
Time frame: 24 weeks
Changes in HOMA-IR, HOMA-β, QUICKI, ISI-M, OGIS and PREDIM indices
Time frame: 24 weeks
Changes in HOMA-IR, HOMA-β and QUICKI indices
Time frame: 12 weeks
Changes in fasting blood concentrations of triglycerides, non esterified fatty acids, LDL cholesterol, HDL cholesterol and Total cholesterol
Time frame: 24 weeks
Changes in fasting blood concentrations of triglycerides, non esterified fatty acids, LDL cholesterol, HDL cholesterol and Total cholesterol
Time frame: 12 weeks
Changes in fasting blood level of PON-1 (Paraoxonase)
Time frame: 24 weeks
Changes in fasting blood level of PON-1 (Paraoxonase)
Time frame: 12 weeks
Changes in the ratio of fasting blood oxidized LDL / fasting blood LDL cholesterol
Time frame: 24 weeks
Changes in the ratio of fasting blood oxidized LDL / fasting blood LDL cholesterol
Time frame: 12 weeks
Changes in fasting blood level of hsCRP
Time frame: 24 weeks
Changes in fasting blood level of hsCRP
Time frame: 12 weeks
Changes in fasting blood levels of ASAT (Aspartate aminotransferase) and ALAT (Alanine aminotransferase)
Time frame: 24 weeks
Changes in fasting blood levels of GGT (Gamma glutamyltransferase)
Time frame: 24 weeks
Changes in fasting blood levels of bilirubin
Time frame: 24 weeks
Changes in fasting blood levels of creatinine
Time frame: 24 weeks
Changes in fasting blood levels of creatinine
Time frame: 12 weeks
Changes in heart rate
Time frame: 24 weeks
Changes in heart rate
Time frame: 12 weeks
Changes in SBP (systolic blood pressure) and DBP (diastolic blood pressure)
Time frame: 24 weeks
Changes in SBP (systolic blood pressure) and DBP (diastolic blood pressure)
Time frame: 12 weeks
Changes in body weight
Time frame: 24 weeks
Changes in body weight
Time frame: 12 weeks
Changes in WC (waist circumference)
Time frame: 24 weeks
Changes in WC (waist circumference)
Time frame: 12 weeks
Changes in HC (hip circumference)
Time frame: 24 weeks
Changes in HP (hip circumference)
Time frame: 12 weeks
Changes in WHR (waist to hip ratio)
Time frame: 24 weeks
Changes in WHR (waist to hip ratio)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David GENDRE, Dr principal investigator
Biofortis Mérieux NutriSciences
Sébastien L PELTIER, PhD study director
Valbiotis
Jean-Marie BARD, Dr-PhD study chair
UFR des Sciences Pharmaceutiques et Biologiques, Nantes, France
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Totum-63 in people with Prediabetes and Type 2 Diabetes, run by Valbiotis at 6 sites in 4 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 7 inclusion and 24 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 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Serbia, Ireland, Slovenia. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in fasting glycemia (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2020.