8 completed, 3 unknown, 1 recruiting, 1 terminated. 9 Not applicable, 3 Phase 1, 3 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 9 | Completed 4, Unknown 3, Recruiting 1, Terminated 1 |
| Phase 1 | 3 | Completed 3 |
| Phase 2 | 3 | Completed 3 |
| Phase 3 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Effects of TOTUM-448 on Liver Fat Content, Cardiometabolic Risk Factors and Gut Microbiota Among Participants with MASLD TOTUM-448, Placebo - Non-Alcoholic Fatty Liver Disease | Not applicable | Recruiting | Valbiotis | 70 | 2024-01-31 | 2024-11-26 |
| Effect of the Food Supplement TOTUM-070 on Lipid Metabolism TOTUM-070, PLACEBO - Hypercholesterolemia | Not applicable | Unknown | Valbiotis | 180 | 2023-10-04 | 2024-07-01 |
| Determination of Biological Activity of Enriched Serum Following TOTUM-448 Consumption TOTUM-448 - NAFLD, MASLD | Not applicable | Completed | Valbiotis | 10 | 2023-09-27 | 2024-05-31 |
| Effects of 6 Weeks TOTUM-070 on Lipid Metabolism and Cardiovascular Health in Individuals at Increased Cardio-metabolic Risk TOTUM-070 - Hypercholesterolemia, Cardiovascular Risk Factor | Not applicable | Terminated | Valbiotis | 31 | 2022-12-14 | 2024-02-09 |
| Effect of TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure TOTUM-854, Placebo - Prehypertension, Elevated Blood Pressure | Not applicable | Unknown | Valbiotis | 410 | 2022-07-15 | 2024-04-23 |
| To Assess TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure Totum-854, Placebo - Elevated Blood Pressure | Not applicable | Unknown | Valbiotis | 400 | 2022-05-30 | 2023-07-18 |
| Mode of Action (MoA) Study of TOTUM-63 in Individuals at Increased Cardio-metabolic Risk TOTUM-63 - Prediabetic State, Dysglycemia | Not applicable | Completed | Valbiotis | 20 | 2022-04-25 | 2023-11-13 |
| Effect of Totum-070 on Lipid Metabolism in Moderate Hypercholesterolemic Subjects TOTUM-070, Placebo - Hypercholesterolemia, Cardiovascular Risk Factor | Not applicable | Completed | Valbiotis | 120 | 2021-02-17 | 2022-03-29 |
| Effect of Totum-63 on Glucose and Lipid Homeostasis in Subjects With Dysglycemia (REVERSE-IT) TOTUM-63 3 intakes per day, Placebo 3 intakes per day, TOTUM-63 2 intakes per day - Prediabetic State, Diabetes type2 | Not applicable | Completed | Valbiotis | 636 | 2020-07-08 | 2023-09-21 |
| Tolerance Study of the Dietary Supplement Lipidrive (ECPH1-03) Lipidrive - Obese | Phase 1 / Phase 2 | Completed | Valbiotis | 20 | 2017-03-02 | 2018-07-06 |
| Effects of Two Herbal Dietary Supplements on Lipid Metabolism in Moderate Hypercholesterolemia and Hypertriglyceridemia VAL070-A, VAL070-B, Placebo - Hypercholesterolemia, Hypertriglyceridemia | Phase 1 / Phase 2 | Completed | Valbiotis | 40 | 2017-01-01 | 2018-07-05 |
| Effect of Totum-63, Active Ingredient of Valedia, on Glucose and Lipid Homeostasis on Subjects With Prediabetes Totum-63, Placebo - Prediabetes, Type 2 Diabetes | Phase 2 / Phase 3 | Completed | Valbiotis | 66 | 2016-10-01 | 2020-10-05 |
| Tolerance Study of the Dietary Supplement Valedia Valedia - Overweight | Phase 1 | Completed | Valbiotis | 14 | 2016-05-01 | 2016-08-09 |
Obesity (5) · Hypercholesterolemia (4) · Overweight (4) · Prediabetic State (3) · Atherosclerosis (2) · Diabetes Mellitus, Type 2 (2) · Dyslipidemias (2) · Hypertension (2) · Hypertriglyceridemia (2) · Insulin Resistance (2) · Non-alcoholic Fatty Liver Disease (2) · Disease (1) · Hyperglycemia (1) · Inflammation (1) · Metabolic Diseases (1)
TOTUM-63 (2)
France (9) · Germany (4) · Bulgaria (2) · Canada (2) · Poland (2) · Hungary (1) · Ireland (1) · Italy (1) · Romania (1) · Serbia (1) · Slovenia (1)
Daniel Menzel, MD (2) · Isabelle Metreau, MD (1) · Patrick Couture, MD FRCP PhD (1)