Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
14 participants
INTERVENTIONAL
2016-05-31
2016-08-31
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
Valedia
Interventions
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Valedia
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
45 Years
65 Years
MALE
Yes
Sponsors
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Centre d'Investigation Clinique INSERM 501, Clermont-Ferrand, France
UNKNOWN
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
OTHER
Valbiotis
INDUSTRY
Responsible Party
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Principal Investigators
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Sébastien L Peltier, PhD
Role: STUDY_DIRECTOR
Valbiotis
Locations
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Centre d'Investigation Clinique
Clermont-Ferrand, , France
Countries
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Other Identifiers
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2015-A01864-45
Identifier Type: -
Identifier Source: org_study_id
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