OverweightPhase 1ECPH1-01NCT02790489
Tolerance Study of the Dietary Supplement Valedia
A Phase 1 study testing Valedia in people with Overweight, run by Valbiotis at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Valedia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to Aug 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Overweight
- Being tested
- Valedia
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValediaDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Valedia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on urine urea
Urine urea
Measured: 10 weeks
Effect on urine creatinine
Urine creatinine
Measured: 10 weeks
Effect on fasting glycemia
Fasting blood glucose
Measured: 10 weeks
Effect on insulin
Plasma insulin
Measured: 10 weeks
Effect on fructosamine
Blood fructosamine
Measured: 10 weeks
Effect on total cholesterol
Blood total cholesterol
Measured: 10 weeks
Effect on HDL cholesterol
Blood HDL cholesterol
Measured: 10 weeks
Effect on LDL cholesterol
Blood LDL cholesterol
Measured: 10 weeks
Effect on triglycerides
Blood triglycerides
Measured: 10 weeks
Effect on oxidized LDL cholesterol
Blood oxidized LDL cholesterol
Measured: 10 weeks
Effect on inflammation
Blood us-CRP
Measured: 10 weeks
Effect on AST
Blood AST
Measured: 10 weeks
Effect on ALT
Blood ALT
Measured: 10 weeks
Effect on gamma GT
Blood gamma GT
Measured: 10 weeks
Effect on alkaline phosphatase
Blood phosphatase alkaline
Measured: 10 weeks
Effect on bilirubin
Blood bilirubin
Measured: 10 weeks
Effect on cardiac function
ECG
Measured: 10 weeks
Secondary outcomes (1)
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)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valbiotis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre d'Investigation Clinique INSERM 501, Clermont-Ferrand, France, Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
- Responsible party
- Sponsor
- Investigators
- Sébastien L Peltier, PhD, Study director, Valbiotis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790489
- Sponsor's protocol ID
- 2015-A01864-45
- Acronym
- ECPH1-01
- Status last verified
- Aug 2016
- First submitted
- 17 May 2016
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valedia Dietary Supplement Tolerance Study Based on Blood, Urinary and Hemodynamic Biological Parameters
- ClinicalTrials.gov ID
- NCT02790489
- Acronym / sponsor ID
- ECPH1-01 / 2015-A01864-45
- Conditions
- Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- ValbiotisIndustry (pharma, biotech, devices)
- Collaborators
- Centre d'Investigation Clinique INSERM 501, Clermont-Ferrand, France, Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
- Study start
- May 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 6 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valedia | Experimental | Dietary Supplement: ValediaDose 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 |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valedia | Dietary supplement | Valedia |
Primary outcome
Effect on urine urea
Time frame: 10 weeks
Urine urea
Effect on urine creatinine
Time frame: 10 weeks
Urine creatinine
Effect on fasting glycemia
Time frame: 10 weeks
Fasting blood glucose
Effect on insulin
Time frame: 10 weeks
Plasma insulin
Effect on fructosamine
Time frame: 10 weeks
Blood fructosamine
Effect on total cholesterol
Time frame: 10 weeks
Blood total cholesterol
Effect on HDL cholesterol
Time frame: 10 weeks
Blood HDL cholesterol
Effect on LDL cholesterol
Time frame: 10 weeks
Blood LDL cholesterol
Effect on triglycerides
Time frame: 10 weeks
Blood triglycerides
Effect on oxidized LDL cholesterol
Time frame: 10 weeks
Blood oxidized LDL cholesterol
Effect on inflammation
Time frame: 10 weeks
Blood us-CRP
Effect on AST
Time frame: 10 weeks
Blood AST
Effect on ALT
Time frame: 10 weeks
Blood ALT
Effect on gamma GT
Time frame: 10 weeks
Blood gamma GT
Effect on alkaline phosphatase
Time frame: 10 weeks
Blood phosphatase alkaline
Effect on bilirubin
Time frame: 10 weeks
Blood bilirubin
Effect on cardiac function
Time frame: 10 weeks
ECG
1 secondary outcome
The response during an oral glucide tolerance test after a standardized breakfast
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien L Peltier, PhD study director
Valbiotis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Valedia in people with Overweight, run by Valbiotis at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on urine urea (time frame: 10 weeks). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2016.