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Completed

NCT Number: NCT02790489

Tolerance Study of the Dietary Supplement Valedia

The objectives of this clinical study are to determine the tolerance of dietary supplement Valedia (blend of plant extracts) through the evaluation of several parameters :

* Various blood biological parameters for tolerance (preprandial): blood glucose, insulin, fructosamine, total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, oxidized LDL, us-CRP, creatinine, ASAT, ALAT, gGT, phosphatase alcaline, bilirubine, urea. * Urinary parameters: urea, creatinine. * Hemodynamic parameters: heart rate and blood pressure. * Cardiac function: ECG. * Weight.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Centre d'Investigation Clinique

Clermont-Ferrand, 63000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • 25 <= BMI < 30 kg.m2

Main Exclusion Criteria:

  • ASAT <= 1,55 microkat/L
  • ALAT <= 1,70 microkat/L
  • gGT <= 2,55 microkat/L
  • 55 <= Creatinine <= 104 micromol/L (+- 10%)
  • Bilirubin < 17,1 micromol/L (+- 10%)
  • 1,7 <= Urea <= 8,3 mmol/L (+- 10%)
  • us-CRP <= 5 mg/L (+- 10%)
  • 0,70 <= Fasting glycemia <= 1,25 g/L (+- 10%)
  • HbA1c <= 6%
  • Medications for diabetes and/or dyslipidemia

Treatment and study plan

Valedia

Dietary Supplement

Primary outcomes

  1. Effect on urine urea

    Time frame: 10 weeks

    Urine urea

  2. Effect on urine creatinine

    Time frame: 10 weeks

    Urine creatinine

  3. Effect on fasting glycemia

    Time frame: 10 weeks

    Fasting blood glucose

  4. Effect on insulin

    Time frame: 10 weeks

    Plasma insulin

  5. Effect on fructosamine

    Time frame: 10 weeks

    Blood fructosamine

  6. Effect on total cholesterol

    Time frame: 10 weeks

    Blood total cholesterol

  7. Effect on HDL cholesterol

    Time frame: 10 weeks

    Blood HDL cholesterol

  8. Effect on LDL cholesterol

    Time frame: 10 weeks

    Blood LDL cholesterol

  9. Effect on triglycerides

    Time frame: 10 weeks

    Blood triglycerides

  10. Effect on oxidized LDL cholesterol

    Time frame: 10 weeks

    Blood oxidized LDL cholesterol

  11. Effect on inflammation

    Time frame: 10 weeks

    Blood us-CRP

  12. Effect on AST

    Time frame: 10 weeks

    Blood AST

  13. Effect on ALT

    Time frame: 10 weeks

    Blood ALT

  14. Effect on gamma GT

    Time frame: 10 weeks

    Blood gamma GT

  15. Effect on alkaline phosphatase

    Time frame: 10 weeks

    Blood phosphatase alkaline

  16. Effect on bilirubin

    Time frame: 10 weeks

    Blood bilirubin

  17. Effect on cardiac function

    Time frame: 10 weeks

    ECG

Secondary outcomes

  1. The response during an oral glucide tolerance test after a standardized breakfast

    Time frame: 10 weeks

    Oral glucose tolerance test (after a standardized breakfast) with glycemia and insulinemia measurements (-10 min, -5 min, +15 min, +30 min, +45 min, +60 min, +90 min, +120 min, arrival at center in fasting state)

Sponsors and collaborators

Lead sponsor

Valbiotis

Industry

Collaborators

  • Centre d'Investigation Clinique INSERM 501, Clermont-Ferrand, France
  • Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques

Registry information

Official study title

Valedia Dietary Supplement Tolerance Study Based on Blood, Urinary and Hemodynamic Biological Parameters

Acronym: ECPH1-01

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 6, 2016
Registry last updated
Aug 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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