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Tolerance Study of the Dietary Supplement Valedia

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02790489
Acronym
ECPH1-01
Enrollment
14
Registered
2016-06-06
Start date
2016-05-31
Completion date
2016-08-31
Last updated
2016-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight

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.

Interventions

DIETARY_SUPPLEMENTValedia

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
45 Years to 65 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Effect on cardiac function10 weeksECG
Effect on urine urea10 weeksUrine urea
Effect on urine creatinine10 weeksUrine creatinine
Effect on fasting glycemia10 weeksFasting blood glucose
Effect on insulin10 weeksPlasma insulin
Effect on fructosamine10 weeksBlood fructosamine
Effect on total cholesterol10 weeksBlood total cholesterol
Effect on HDL cholesterol10 weeksBlood HDL cholesterol
Effect on LDL cholesterol10 weeksBlood LDL cholesterol
Effect on triglycerides10 weeksBlood triglycerides
Effect on oxidized LDL cholesterol10 weeksBlood oxidized LDL cholesterol
Effect on inflammation10 weeksBlood us-CRP
Effect on AST10 weeksBlood AST
Effect on ALT10 weeksBlood ALT
Effect on gamma GT10 weeksBlood gamma GT
Effect on alkaline phosphatase10 weeksBlood phosphatase alkaline
Effect on bilirubin10 weeksBlood bilirubin

Secondary

MeasureTime frameDescription
The response during an oral glucide tolerance test after a standardized breakfast10 weeksOral 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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026