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Tolerance Study of the Dietary Supplement Valedia (ECPH1-01)

V

Valbiotis

Status and phase

Completed
Phase 1

Conditions

Overweight

Treatments

Dietary Supplement: Valedia

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02790489
2015-A01864-45

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

Male

Ages

45 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

14 participants in 1 patient group

Valedia
Experimental group
Description:
Dose 1 : 2,5 g (4 capsules) Valedia per day during 4 weeks Dose 2 : 5 g (8 capsules) Valedia per day during 4 weeks 2 weeks (wash-out period) between the 2 doses
Treatment:
Dietary Supplement: Valedia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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