NCT02790489

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 6, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 9, 2016

Status Verified

August 1, 2016

Enrollment Period

3 months

First QC Date

May 17, 2016

Last Update Submit

August 8, 2016

Conditions

Overweight

Outcome Measures

Primary Outcomes (17)

  • Effect on urine urea

    Urine urea

    10 weeks

  • Effect on urine creatinine

    Urine creatinine

    10 weeks

  • Effect on fasting glycemia

    Fasting blood glucose

    10 weeks

  • Effect on insulin

    Plasma insulin

    10 weeks

  • Effect on fructosamine

    Blood fructosamine

    10 weeks

  • Effect on total cholesterol

    Blood total cholesterol

    10 weeks

  • Effect on HDL cholesterol

    Blood HDL cholesterol

    10 weeks

  • Effect on LDL cholesterol

    Blood LDL cholesterol

    10 weeks

  • Effect on triglycerides

    Blood triglycerides

    10 weeks

  • Effect on oxidized LDL cholesterol

    Blood oxidized LDL cholesterol

    10 weeks

  • Effect on inflammation

    Blood us-CRP

    10 weeks

  • Effect on AST

    Blood AST

    10 weeks

  • Effect on ALT

    Blood ALT

    10 weeks

  • Effect on gamma GT

    Blood gamma GT

    10 weeks

  • Effect on alkaline phosphatase

    Blood phosphatase alkaline

    10 weeks

  • Effect on bilirubin

    Blood bilirubin

    10 weeks

  • Effect on cardiac function

    ECG

    10 weeks

Secondary Outcomes (1)

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

    10 weeks

Study Arms (1)

Valedia

EXPERIMENTAL

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

Interventions

ValediaDIETARY_SUPPLEMENT
Valedia

Eligibility Criteria

Age45 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \<= BMI \< 30 kg.m2

You may not qualify if:

  • ASAT \<= 1,55 microkat/L
  • ALAT \<= 1,70 microkat/L
  • gGT \<= 2,55 microkat/L
  • \<= Creatinine \<= 104 micromol/L (+- 10%)
  • Bilirubin \< 17,1 micromol/L (+- 10%)
  • ,7 \<= Urea \<= 8,3 mmol/L (+- 10%)
  • us-CRP \<= 5 mg/L (+- 10%)
  • ,70 \<= Fasting glycemia \<= 1,25 g/L (+- 10%)
  • HbA1c \<= 6%
  • Medications for diabetes and/or dyslipidemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Investigation Clinique

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sébastien L Peltier, PhD

    Valbiotis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2016

First Posted

June 6, 2016

Study Start

May 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 9, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Locations

FR(1)