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

August 8, 2016 updated by: Valbiotis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63000
        • Centre d'investigation Clinique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Valedia
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
Dietary supplement: Valedia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect on urine urea
Time Frame: 10 weeks
Urine urea
10 weeks
Effect on urine creatinine
Time Frame: 10 weeks
Urine creatinine
10 weeks
Effect on fasting glycemia
Time Frame: 10 weeks
Fasting blood glucose
10 weeks
Effect on insulin
Time Frame: 10 weeks
Plasma insulin
10 weeks
Effect on fructosamine
Time Frame: 10 weeks
Blood fructosamine
10 weeks
Effect on total cholesterol
Time Frame: 10 weeks
Blood total cholesterol
10 weeks
Effect on HDL cholesterol
Time Frame: 10 weeks
Blood HDL cholesterol
10 weeks
Effect on LDL cholesterol
Time Frame: 10 weeks
Blood LDL cholesterol
10 weeks
Effect on triglycerides
Time Frame: 10 weeks
Blood triglycerides
10 weeks
Effect on oxidized LDL cholesterol
Time Frame: 10 weeks
Blood oxidized LDL cholesterol
10 weeks
Effect on inflammation
Time Frame: 10 weeks
Blood us-CRP
10 weeks
Effect on AST
Time Frame: 10 weeks
Blood AST
10 weeks
Effect on ALT
Time Frame: 10 weeks
Blood ALT
10 weeks
Effect on gamma GT
Time Frame: 10 weeks
Blood gamma GT
10 weeks
Effect on alkaline phosphatase
Time Frame: 10 weeks
Blood phosphatase alkaline
10 weeks
Effect on bilirubin
Time Frame: 10 weeks
Blood bilirubin
10 weeks
Effect on cardiac function
Time Frame: 10 weeks
ECG
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valbiotis

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ACTUAL)

August 1, 2016

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

June 1, 2016

First Posted (ESTIMATE)

June 6, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 9, 2016

Last Update Submitted That Met QC Criteria

August 8, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-A01864-45

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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