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

Primary Purpose

Overweight

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Valedia
Sponsored by
Valbiotis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Centre d'Investigation Clinique

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Valedia

Arm 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

Outcomes

Primary Outcome Measures

Effect on urine urea
Urine urea
Effect on urine creatinine
Urine creatinine
Effect on fasting glycemia
Fasting blood glucose
Effect on insulin
Plasma insulin
Effect on fructosamine
Blood fructosamine
Effect on total cholesterol
Blood total cholesterol
Effect on HDL cholesterol
Blood HDL cholesterol
Effect on LDL cholesterol
Blood LDL cholesterol
Effect on triglycerides
Blood triglycerides
Effect on oxidized LDL cholesterol
Blood oxidized LDL cholesterol
Effect on inflammation
Blood us-CRP
Effect on AST
Blood AST
Effect on ALT
Blood ALT
Effect on gamma GT
Blood gamma GT
Effect on alkaline phosphatase
Blood phosphatase alkaline
Effect on bilirubin
Blood bilirubin
Effect on cardiac function
ECG

Secondary Outcome Measures

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

Full Information

First Posted
May 17, 2016
Last Updated
August 8, 2016
Sponsor
Valbiotis
Collaborators
Centre d'Investigation Clinique INSERM 501, Clermont-Ferrand, France, Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
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1. Study Identification

Unique Protocol Identification Number
NCT02790489
Brief Title
Tolerance Study of the Dietary Supplement Valedia
Acronym
ECPH1-01
Official Title
Valedia Dietary Supplement Tolerance Study Based on Blood, Urinary and Hemodynamic Biological Parameters
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valbiotis
Collaborators
Centre d'Investigation Clinique INSERM 501, Clermont-Ferrand, France, Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Valedia
Arm Type
Experimental
Arm 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
Intervention Type
Dietary Supplement
Intervention Name(s)
Valedia
Primary Outcome Measure Information:
Title
Effect on urine urea
Description
Urine urea
Time Frame
10 weeks
Title
Effect on urine creatinine
Description
Urine creatinine
Time Frame
10 weeks
Title
Effect on fasting glycemia
Description
Fasting blood glucose
Time Frame
10 weeks
Title
Effect on insulin
Description
Plasma insulin
Time Frame
10 weeks
Title
Effect on fructosamine
Description
Blood fructosamine
Time Frame
10 weeks
Title
Effect on total cholesterol
Description
Blood total cholesterol
Time Frame
10 weeks
Title
Effect on HDL cholesterol
Description
Blood HDL cholesterol
Time Frame
10 weeks
Title
Effect on LDL cholesterol
Description
Blood LDL cholesterol
Time Frame
10 weeks
Title
Effect on triglycerides
Description
Blood triglycerides
Time Frame
10 weeks
Title
Effect on oxidized LDL cholesterol
Description
Blood oxidized LDL cholesterol
Time Frame
10 weeks
Title
Effect on inflammation
Description
Blood us-CRP
Time Frame
10 weeks
Title
Effect on AST
Description
Blood AST
Time Frame
10 weeks
Title
Effect on ALT
Description
Blood ALT
Time Frame
10 weeks
Title
Effect on gamma GT
Description
Blood gamma GT
Time Frame
10 weeks
Title
Effect on alkaline phosphatase
Description
Blood phosphatase alkaline
Time Frame
10 weeks
Title
Effect on bilirubin
Description
Blood bilirubin
Time Frame
10 weeks
Title
Effect on cardiac function
Description
ECG
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
The response during an oral glucide tolerance test after a standardized breakfast
Description
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)
Time Frame
10 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien L Peltier, PhD
Organizational Affiliation
Valbiotis
Official's Role
Study Director
Facility Information:
Facility Name
Centre d'Investigation Clinique
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Tolerance Study of the Dietary Supplement Valedia

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