Effect of Totum-63, Active Ingredient of Valedia, on Glucose and Lipid Homeostasis on Subjects With Prediabetes

NCT02868177 | Completed Phase 2 DMC

• 1 other identifier: 2016-A00484-47
• Study Type: interventional
• Target: 66
• Locations: 4 countries
• Sites: 6

Brief 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 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.

Conditions

Prediabetes; Type 2 Diabetes; Hypertriglyceridemia; Obesity; Disease; Insulin Resistance

Keywords

Prevention

Outcome Measures

Primary Outcomes (1)

• Changes in fasting glycemia

  Defined as the difference V3 (24 weeks) - V1 (baseline) in g/L

  24 weeks

Secondary Outcomes (36)

• Changes in fasting glycemia

  12 weeks

• Changes in fasting blood levels of HbA1c

  24 weeks

• Changes in fasting blood levels of HbA1c

  12 weeks

• Changes in fasting blood levels of fructosamine

  24 weeks

• Changes in fasting blood levels of fructosamine

  12 weeks

Other Outcomes (8)

• Changes in total energy intake

  24 weeks

• Changes in total energy intake

  12 weeks

• Changes in percentage of energy intake from fat, carbohydrates and protein

  24 weeks

Study Arms (2)

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

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.

Dietary Supplement: Placebo

Interventions

Totum-63 DIETARY_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.

Totum-63

Placebo DIETARY_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.

Placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Valbiotis: lead
• Biofortis Mérieux NutriSciences: collaborator
• Institut Pasteur de Lille: collaborator

Study Sites (6)

Institut Pasteur de Lille

Lille, 59019, France

Location

Biofortis Mérieux NutriSciences Clinical Investigation Center

Saint-Herblain, 44800, France

Location

Atlantia Food Clinical Trials

Cork, T23 R50R, Ireland

Location

Clinical center of Kragujevac, / Poseidon CRO

Kragujevac, Serbia

Location

Clinical Center of Vojvodina / Poseidon CRO

Novi Sad, 21000, Serbia

Location

University Medical Centre Ljubljana / Poseidon CRO

Ljubljana, Slovenia

Location

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus, Type 2; Hypertriglyceridemia; Obesity; Disease; Insulin Resistance

Interventions

TOTUM-63

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Hyperinsulinism

Study Officials

• David GENDRE, Dr

  Biofortis Mérieux NutriSciences

  PRINCIPAL INVESTIGATOR

• Sébastien L PELTIER, PhD

  Valbiotis

  STUDY DIRECTOR

• Jean-Marie BARD, Dr-PhD

  UFR des Sciences Pharmaceutiques et Biologiques, Nantes, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 16, 2016
• Study Start: October 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: October 5, 2020

Record last verified: 2020-10

Locations

SE (2); SL (1); IE (1); FR (2)