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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes type2; Prediabetic State; Dysglycemia
• Intervention / Treatment: Dietary supplement: TOTUM-63 3 intakes per day; Dietary supplement: Placebo 3 intakes per day; Dietary supplement: TOTUM-63 2 intakes per day

• Study Type: Interventional
• Enrollment (Actual): 636
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Botevgrad, Bulgaria
    • MHAT-Botevgrad EOOD, Botevgrad
  • Plovdiv, Bulgaria, 4004
    • MHAT Sveta Karidad, First department of Internal Diseases
  • Plovdiv, Bulgaria
    • Ambulatory for IPSOC in Endocrynology and Metabolic Diseases ENDO MED-CONSULT EOOD
  • Plovdiv, Bulgaria
    • Diagnostic-consultative center 7 EOOD, Plovdiv
  • Sofia, Bulgaria, 1431
    • Diagnostic Consultative Center "ALEXANDROVSKA"
  • Sofia, Bulgaria, 1431
    • University Multiprofile Hospital for active treatment "Alexandrovska" EAD Clinic of Endocrinology and metabolic diseases
  • Sofia, Bulgaria, 1606
    • 4th Multiprofile Hospital for active treatment - EAD, Internal Diseases Departement
  • Sofia, Bulgaria
    • Diagnostic Consultative Center
• France
  • Amiens, France, 80054
    • CHU Amiens
  • Arras, France, 62000
    • CH Arras
  • Clermont-Ferrand, France, 63000
    • CIC Clermont Ferrand
  • Dijon, France, 21000
    • CEN Nutriment
  • Gières, France, 38610
    • Eurofins Optimed
  • Grenoble, France, 38043
    • CHU Grenoble
  • Lille, France, 59037
    • CHU Lille
  • Lille, France, 59019
    • Institut Pasteur de Lille
  • Nantes, France, 44093
    • CHU Nantes
  • Nice, France, 06202
    • CHU Nice
  • Paris, France, 75012
    • Unité d'Investigation Clinique Biofortis Mérieux NutriSciences
  • Pierre-Bénite, France, 69310
    • Unité de Recherche Clinique en Immunologie Lyon Sud
  • Rouen, France, 76000
    • CHU Rouen
  • Saint-Herblain, France, 44800
    • Biofortis Mérieux NutriSciences
• Germany
  • Berlin, Germany, 13467
    • Analyze & Realize
  • Dresden, Germany, 01069
    • Klinische Forschung Dresden
  • Essen, Germany, 45355
    • Medizentrum Essen Borbeck
  • Esslingen, Germany, 73728
    • Biotesys
  • Hamburg, Germany, 20253
    • Klinische Forschung Hamburg
  • Hannover, Germany, 30159
    • Klinische Forschung Hannover-Mitte
  • Karlsruhe, Germany, 76137
    • Klinische Forschung Karlsruhe
  • Künzing, Germany
    • Gemeinschaftspraxis Dr. Med C. Klein/J Minnich
  • Sankt Ingbert, Germany
    • Zentrum für klinische Studien
  • Schwerin, Germany, 19055
    • Klinische Forschung Schwerin
  • Stuttgart, Germany, 70599
    • Zentrum für Klinische Ernährung Stuttgart
• Hungary
  • Balatonfüred, Hungary, 8230
    • Drug Resesarch Center (DRC)
  • Budapest, Hungary, 1033
    • ClinExpert Medical Center
  • Békéscsaba, Hungary, 5600
    • Trial Pharma Ltd
  • Eger, Hungary, 3300
    • Agria - Study Ltd
  • Gyula, Hungary, 5703
    • Trial Pharma Ltd
  • Győr, Hungary, 9000
    • Trial Pharma Ltd
  • Miskolc, Hungary, 3529
    • Clinical Research Unit (CRU)
  • Orosháza, Hungary, 5900
    • Trial Pharma Ltd
• Italy
  • Catanzaro, Italy, 88100
    • Azienda Ospedaliera Universitaria "Mater Domini"
  • Milan, Italy, 20132
    • IRCCS Ospedale San Raffaele
  • Palermo, Italy, 90127
    • Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
  • Roma, Italy, 00161
    • Policlinico Umberto I
• Poland
  • Bydgoszcz, Poland
    • Vitamed
  • Katowice, Poland
    • Grupowa Praktyka Lekarska s.c
  • Kraków, Poland
    • Centrum Medyczne Linden
• Romania
  • Bucarest, Romania
    • Sana Monitoring
  • Caracal, Romania
    • Spitalul Municipal Caracal
  • Călăraşi, Romania
    • Ames Research Cente
  • Reșca, Romania
    • Clintrial Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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;
• 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.

Exclusion Criteria:

• 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;

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TOTUM-63 3 intakes per day; Experimental active diet supplement TOTUM-63 taken 3 times per day (blinded arm)	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); Other Names: Active product 3 intakes per day
Placebo Comparator: Placebo 3 intakes per day; Placebo comparator taken 3 times per day (blinded arm)	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); Other Names: Comparator product 3 intakes per day
Experimental: TOTUM-63 2 intakes per day; Experimental active diet supplement TOTUM-63 taken 2 times per day (open arm)	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); Other Names: Active product 2 intakes per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	V3 (24 weeks of intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
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	V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
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)	V1 (baseline), V2 (12 weeks of intervention), V3 (24 weeks of intervention) and V4 (12 weeks and the end of intervention)
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	V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
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	V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
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	V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
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	V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
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	V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
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	V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
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	V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
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	V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
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	V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
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	V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
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	V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
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	V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
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	V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
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	V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
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	V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
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	V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
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	V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
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	V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
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	V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
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	V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
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	V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
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	V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

Collaborators and Investigators

• Sponsor: Valbiotis
• Collaborators: Biofortis Mérieux NutriSciences
• Investigators: Principal Investigator: Isabelle METREAU, MD, Biofortis Mérieux NutriSciences

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2020
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): June 23, 2023

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Prediabetes; Type 2 diabetes; Diet; Hyperglycemia; Plant extracts; Diabetes risk; Insulinemia; Dysglycemia; Health condition; Diet supplement; Hygiene and dietary recommendations
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State
• Other Study ID Numbers: PEC16075; 2020-A00604-35 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No