NAFLDCnC-TOTUM448NCT06047847
Determination of Biological Activity of Enriched Serum Following TOTUM-448 Consumption
A study testing TOTUM-448 in people with NAFLD and MASLD, run by Valbiotis at 1 site in France.
Trial summary
Dietary intakes of saturated fatty acids remain well above nutritional recommendations for most European countries. This may progressively lead to a pro-inflammatory context and the alteration of lipid metabolism in the liver. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- NAFLD, MASLD, Mild Inflammatory Context
- What is being tested?
- TOTUM-448
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 27 Sep 2023to 11 Apr 2024
- Phase
- Interventional
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Main Inclusion Criteria:
- Lipid profile within reference values
- Glycemia < 100mg/dL
- Normal hepatic function
- Normal blood formulation
- Normal renal function
- BMI between 20 and 28kg/m2
- Non smoker or occasional smoker
Main Exclusion Criteria:
- All types of vaccination within one month
- Alcohol intakes superior to World Health Organization recommendations
- Ongoing pharmacological, dietary supplement and/or probiotic treatment
- Consumption of enriched functional foods or dietary supplements within two weeks of inclusion
- Any known disease
- Allergy to ingredients of the study product
- With dietary habits incompatible with the study conduct
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Biological Activity of Enriched Serum Among Healthy Participants After Consumption of the Food Supplement TOTUM-448
Dietary intakes of saturated fatty acids remain well above nutritional recommendations for most European countries. This may progressively lead to a pro-inflammatory context and the alteration of lipid metabolism in the liver. The hypothesis of this study is that TOTUM-448 promotes the normal function of hepatocytes in a mild inflammatory context. To determine the cellular and molecular effects of TOTUM-448, circulating bioactive molecules after TOTUM-448 intake will be collected and then studied in human hepatocytes using an innovative ex vivo clinical approach developed by Clinic'n'Cell.
- Conditions
- NAFLD, MASLD, Mild Inflammatory Context
- Being tested
- TOTUM-448
- Keywords
- ex vivo, lipid metabolism, inflammation, hepatocytes, oxidative stress, plant extract, polyphenols, dietary/food supplement
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOTUM-448Dietary supplement
The study is divided in two phases. The first clinical phase of the project is aimed at determining TOTUM-448's metabolites absorption peak (two galenic forms will be tested: capsules and powder). Then, human circulating metabolites from polyphenols will be quantified and characterized by ultra-high performance liquid chromatography hyphenated with tandem mass spectrometry (UPLC-MS/MS). Once the absorption profile is characterized, volunteers will visit once again the clinical center for the collection of serum fractions either naïve (before ingestion) or enriched (containing circulating metabolites following TOTUM-448 ingestion). The enriched fraction (circulating bioactive collection) will be collected at t-max as characterized in the first phase (absorption profil's peak). Finally, biological activity of TOTUM-448 on human hepatocytes will be studied by comparing naïve serum and serum containing circulating metabolites according to an in vitro protocol.
| Study group | Role | What they receive |
|---|---|---|
| TOTUM-448 | Experimental | 10 healthy men will consume an acute intake of 4.284g of TOTUM-448 on three separate occasions.
Phase 1: once per galenic form (capsule and powder). Phase 2: once (capsule only). Receives: Dietary Supplement: TOTUM-448 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the influence of circulating bioactive metabolites in blood stream resulting from the intake of TOTUM-448 on viability of human hepatocytes in a hyperlipidic pro-inflammatory context.
Naïve will be compared to enriched serum from the 10 healthy participants at the previously determined t-max.
Measured: At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.
Evaluate the influence of circulating bioactive metabolites in blood stream resulting from the intake of TOTUM-448 on cholesterol storage of human hepatocytes in a hyperlipidic pro-inflammatory context.
Naïve will be compared to enriched serum from the 10 healthy participants at the previously determined t-max.
Measured: At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.
Evaluate the influence of circulating bioactive metabolites in blood stream resulting from the intake of TOTUM-448 on triglyceride storage of human hepatocytes in a hyperlipidic pro-inflammatory context.
Naïve will be compared to enriched serum from the 10 healthy participants at the previously determined t-max.
Measured: At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.
Evaluate the influence of circulating bioactive metabolites in blood stream resulting from the intake of TOTUM-448 on oxidative stress status of human hepatocytes in a hyperlipidic pro-inflammatory context.
Naïve will be compared to enriched serum from the 10 healthy participants at the previously determined t-max.
Measured: At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.
Evaluate the influence of circulating bioactive metabolites in blood stream resulting from the intake of TOTUM-448 on pro-inflammatory cytokine expression of human hepatocytes in a hyperlipidic pro-inflammatory context.
Naïve will be compared to enriched serum from the 10 healthy participants at the previously determined t-max.
Measured: At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.
Secondary outcomes (1)
Time to reach the maximum concentration in serum of detectable polyphenol metabolite concentrations by UPLC-MS/MS.
After ingestion of TOTUM-448 the concentration in serum of detectable polyphenol metabolites will be assessed every 20 minutes during 240 minutes.
Measured: From timepoint 0 minute to timepoint 240 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start27 Sep 2023
- Primary completion8 Jan 2024
- Study completion11 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NAFLDStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An ex vivo clinical approach.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valbiotis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinic'n'Cell, University Hospital, Clermont-Ferrand
- Responsible party
- Sponsor
- Investigators
- Gisèle Pickering, PhD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047847
- Sponsor's protocol ID
- 2023-A00579-36
- Acronym
- CnC-TOTUM448
- Status last verified
- May 2024
- First submitted
- 5 Sep 2023
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wauquier F, Boutin-Wittrant L, Krisa S, Valls J, Langhi C, Otero YF, Sirvent P, Peltier S, Bargetto M, Cazaubiel M, Sapone V, Bouchard-Mercier A, Roux V, Macian N, Pickering G, Wittrant Y. Circulating Human Metabolites Resulting from TOTUM-070 Absorption (a Plant-Based, Polyphenol-Rich Ingredient) Improve Lipid Metabolism in Human Hepatocytes: Lessons from an Original Ex Vivo Clinical Trial. Nutrients. 2023 Apr 14;15(8):1903. doi: 10.3390/nu15081903.
PubMed 37111121
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Biological Activity of Enriched Serum Among Healthy Participants After Consumption of the Food Supplement TOTUM-448
- ClinicalTrials.gov ID
- NCT06047847
- Acronym / sponsor ID
- CnC-TOTUM448 / 2023-A00579-36
- Conditions
- NAFLD, MASLD, Mild Inflammatory Context
- Keywords
- ex vivo, lipid metabolism, inflammation, hepatocytes, oxidative stress, plant extract, polyphenols, dietary/food supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- ValbiotisIndustry (pharma, biotech, devices)
- Collaborators
- Clinic'n'Cell, University Hospital, Clermont-Ferrand
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 21 Sep 2023 (actual)
- 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.
Dietary intakes of saturated fatty acids remain well above nutritional recommendations for most European countries. This may progressively lead to a pro-inflammatory context and the alteration of lipid metabolism in the liver. The hypothesis of this study is that TOTUM-448 promotes the normal function of hepatocytes in a mild inflammatory context. To determine the cellular and molecular effects of TOTUM-448, circulating bioactive molecules after TOTUM-448 intake will be collected and then studied in human hepatocytes using an innovative ex vivo clinical approach developed by Clinic'n'Cell.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An ex vivo clinical approach.
| Arm | Type | Receives |
|---|---|---|
| TOTUM-448 | Experimental | Dietary Supplement: TOTUM-44810 healthy men will consume an acute intake of 4.284g of TOTUM-448 on three separate occasions. Phase 1: once per galenic form (capsule and powder). Phase 2: once (capsule only). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- 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 |
|---|---|---|
| TOTUM-448The study is divided in two phases. The first clinical phase of the project is aimed at determining TOTUM-448's metabolites absorption peak (two galenic forms will be tested: capsules and powder). Then, human circulating metabolites from polyphenols will be quantified and characterized by ultra-high performance liquid chromatography hyphenated with tandem mass spectrometry (UPLC-MS/MS). Once the absorption profile is characterized, volunteers will visit once again the clinical center for the collection of serum fractions either naïve (before ingestion) or enriched (containing circulating metabolites following TOTUM-448 ingestion). The enriched fraction (circulating bioactive collection) will be collected at t-max as characterized in the first phase (absorption profil's peak). Finally, biological activity of TOTUM-448 on human hepatocytes will be studied by comparing naïve serum and serum containing circulating metabolites according to an in vitro protocol. | Dietary supplement | TOTUM-448 |
Primary outcome
Evaluate the influence of circulating bioactive metabolites in blood stream resulting from the intake of TOTUM-448 on viability of human hepatocytes in a hyperlipidic pro-inflammatory context.
Time frame: At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.
Naïve will be compared to enriched serum from the 10 healthy participants at the previously determined t-max.
Evaluate the influence of circulating bioactive metabolites in blood stream resulting from the intake of TOTUM-448 on cholesterol storage of human hepatocytes in a hyperlipidic pro-inflammatory context.
Time frame: At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.
Naïve will be compared to enriched serum from the 10 healthy participants at the previously determined t-max.
Evaluate the influence of circulating bioactive metabolites in blood stream resulting from the intake of TOTUM-448 on triglyceride storage of human hepatocytes in a hyperlipidic pro-inflammatory context.
Time frame: At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.
Naïve will be compared to enriched serum from the 10 healthy participants at the previously determined t-max.
Evaluate the influence of circulating bioactive metabolites in blood stream resulting from the intake of TOTUM-448 on oxidative stress status of human hepatocytes in a hyperlipidic pro-inflammatory context.
Time frame: At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.
Naïve will be compared to enriched serum from the 10 healthy participants at the previously determined t-max.
Evaluate the influence of circulating bioactive metabolites in blood stream resulting from the intake of TOTUM-448 on pro-inflammatory cytokine expression of human hepatocytes in a hyperlipidic pro-inflammatory context.
Time frame: At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.
Naïve will be compared to enriched serum from the 10 healthy participants at the previously determined t-max.
1 secondary outcome
Time to reach the maximum concentration in serum of detectable polyphenol metabolite concentrations by UPLC-MS/MS.
Time frame: From timepoint 0 minute to timepoint 240 minutes.
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 31 May 2024.
- Background: PubMed 37111121Wauquier F, Boutin-Wittrant L, Krisa S, Valls J, Langhi C, Otero YF, Sirvent P, Peltier S, Bargetto M, Cazaubiel M, Sapone V, Bouchard-Mercier A, Roux V, Macian N, Pickering G, Wittrant Y. Circulating Human Metabolites Resulting from TOTUM-070 Absorption (a Plant-Based, Polyphenol-Rich Ingredient) Improve Lipid Metabolism in Human Hepatocytes: Lessons from an Original Ex Vivo Clinical Trial. Nutrients. 2023 Apr 14;15(8):1903. doi: 10.3390/nu15081903.
- Individual participant dataSharing planned: No
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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.
Gisèle Pickering, PhD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TOTUM-448 in people with NAFLD and MASLD, 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 31 May 2024. 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.
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?
Evaluate the influence of circulating bioactive metabolites in blood stream resulting from the intake of TOTUM-448 on viability of human hepatocytes in a hyperlipidic pro-inflammatory context. (time frame: At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06047847, which also lists 1 linked publication.
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 31 May 2024.