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

NACompletedINTERVENTIONAL
Enrollment

636

Participants

Timeline

Start Date

July 8, 2020

Primary Completion Date

January 31, 2023

Study Completion Date

June 23, 2023

Conditions
Prediabetic StateDiabetes type2Dysglycemia
Interventions
DIETARY_SUPPLEMENT

TOTUM-63 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)

DIETARY_SUPPLEMENT

Placebo 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)

DIETARY_SUPPLEMENT

TOTUM-63 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)

Trial Locations (52)

1033

ClinExpert Medical Center, Budapest

1431

"Diagnostic Consultative Center ALEXANDROVSKA", Sofia

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

1606

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

3300

Agria - Study Ltd, Eger

3529

Clinical Research Unit (CRU), Miskolc

4004

MHAT Sveta Karidad, First department of Internal Diseases, Plovdiv

5600

Trial Pharma Ltd, Békéscsaba

5703

Trial Pharma Ltd, Gyula

5900

Trial Pharma Ltd, Orosháza

8230

Drug Resesarch Center (DRC), Balatonfüred

9000

Trial Pharma Ltd, Győr

13467

Analyze & Realize, Berlin

19055

Klinische Forschung Schwerin, Schwerin

20132

IRCCS Ospedale San Raffaele, Milan

20253

Klinische Forschung Hamburg, Hamburg

21000

CEN Nutriment, Dijon

30159

Klinische Forschung Hannover-Mitte, Hanover

38043

CHU Grenoble, Grenoble

38610

Eurofins Optimed, Gières

44093

CHU Nantes, Nantes

44800

Biofortis Mérieux NutriSciences, Saint-Herblain

45355

Medizentrum Essen Borbeck, Essen

59019

Institut Pasteur de Lille, Lille

59037

CHU Lille, Lille

62000

CH Arras, Arras

63000

CIC Clermont Ferrand, Clermont-Ferrand

69310

Unité de Recherche Clinique en Immunologie Lyon Sud, Pierre-Bénite

70599

Zentrum für Klinische Ernährung Stuttgart, Stuttgart

73728

Biotesys, Esslingen am Neckar

75012

Unité d'Investigation Clinique Biofortis Mérieux NutriSciences, Paris

76000

CHU Rouen, Rouen

76137

Klinische Forschung Karlsruhe, Karlsruhe

80054

CHU Amiens, Amiens

88100

"Azienda Ospedaliera Universitaria Mater Domini", Catanzaro

90127

"Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone", Palermo

Unknown

MHAT-Botevgrad EOOD, Botevgrad, Botevgrad

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

Diagnostic-consultative center 7 EOOD, Plovdiv, Plovdiv

Diagnostic Consultative Center, Sofia

Gemeinschaftspraxis Dr. Med C. Klein/J Minnich, Künzing

Zentrum fur Klinische Studien, Sankt Ingbert

Vitamed, Bydgoszcz

Grupowa Praktyka Lekarska s.c, Katowice

Centrum Medyczne Linden, Krakow

Sana Monitoring, Bucharest

Spitalul Municipal Caracal, Caracal

Ames Research Cente, Călăraşi

Clintrial Medical Center, Reșca

06202

CHU Nice, Nice

01069

Klinische Forschung Dresden, Dresden

00161

Policlinico Umberto I, Roma

All Listed Sponsors
collaborator

Biofortis Mérieux NutriSciences

OTHER

lead

Valbiotis

INDUSTRY

NCT04423302 - Effect of Totum-63 on Glucose and Lipid Homeostasis in Subjects With Dysglycemia (REVERSE-IT) | Biotech Hunter | Biotech Hunter