HypercholesterolemiaHEARTIINCT06243484
Effect of the Food Supplement TOTUM-070 on Lipid Metabolism
A study testing TOTUM-070 in people with Hypercholesterolemia, run by Valbiotis at 1 site in Germany.
Trial summary
This clinical trial is to confirm the effects of TOTUM-070, a mix of 5 plants extracts, consumed at the daily regimen of two times per day, on fasting blood LDL cholesterol concentrations in moderately hypercholesterolemic subjects after 12 weeks of consumption (V3). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- TOTUM-070
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- 4 Oct 2023to 30 Apr 2025
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Main Inclusion Criteria:
- I1. From 18 to 70 years (including ranges);
- I2. BMI of ≥18.5 and ≤35 kg/m²;
- I3. Moderately hypercholesterolemic subject without any clinical symptoms of hypercholesterolemia (xanthoma, recurrent chest and/or leg pain…) and not requiring immediate pharmacological lipid-lowering treatment;
- I4. Weight stable within ± 5% in the last three months before V0;
- I5. SCORE2 - SCORE2-OP (Older Persons) Cardiovascular Risk Chart
Main Exclusion Criteria:
- E1. Suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal dysfunction or other metabolic disorder needing a dose adjustment in drug intervention according to the professional recommendations;
- E2. Suffering from an uncontrolled arterial hypertension;
- E3. With a history of ischemic cardiovascular event;
- E4. Having undergone recent surgical procedure in the past 6 months before V0 or planned in the 5 months to come;
- E5. History of bariatric surgery;
- E6. Suffering from a severe chronic disease;
- E7. For women: ongoing pregnancy (as evidenced by a positive test for β-Human Chorionic Gonadotropin, i.e. > 5 mUI/mL, realized at V0) or breastfeeding or finished since less than 6 months before V0 or intending to become pregnant within 5 months ahead;
- E8. Under cholesterol and/or lipid-lowering treatment or stopped less than 3 months before the inclusion visit V0;
- E9. Under medication which could affect blood lipid parameters or stopped less than 3 months before the inclusion visit V0 (antihypertensive stable long-term treatment tolerated);
- E10. Consuming more than 3 standard drinks daily of alcoholic beverage for men or 2 standard drinks daily for women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Investigate the Effect of the Food Supplement TOTUM-070 on Lipid Metabolism in Moderately Hypercholesterolemic Subjects After 3 Months of Supplementation
This clinical trial is to confirm the effects of TOTUM-070, a mix of 5 plants extracts, consumed at the daily regimen of two times per day, on fasting blood LDL cholesterol concentrations in moderately hypercholesterolemic subjects after 12 weeks of consumption (V3).
Read the detailed description
The main objective is to confirm the efficacy of a 4.995g/day dose of TOTUM-070 versus placebo on fasting blood LDL cholesterol level (Ultracentrifugation (UC) method) in moderately hypercholesterolemic subjects following 12 weeks of consumption (V3).
The proposed double-blinded, placebo-controlled, clinical study will provide further insight into the safety and efficacy of TOTUM-070 at the same dose (4.995g/day) on a shorter supplementation period (3 months) than the previous one (6 months), as well as assess the effect after the follow-up period without product intake.
- Conditions
- Hypercholesterolemia
- Being tested
- TOTUM-070, PLACEBO
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOTUM-070Dietary supplement
Also called Active product 2 intakes per day
12 weeks of TOTUM-070 supplementation with Placebo (blinded arms)
PLACEBODietary supplement
Also called Comparator product 2 intakes per day
8 capsules per day to consume orally in two intakes
| Study group | Role | What they receive |
|---|---|---|
| TOTUM-070 | Experimental | The experimental arm will be supplemented with TOTUM-070 twice a day Receives: Dietary Supplement: TOTUM-070 |
| PLACEBO | Placebo comparator | The placebo comparator arm will be supplemented with a placebo twice a day Receives: Dietary Supplement: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of fasting blood LDL cholesterol level
Fasting blood LDL cholesterol level by Ultracentrifugation method
Measured: Baseline (V1) and End of consumption after 12 weeks (V3)
Secondary outcomes (10)
Evolution of fasting blood LDL cholesterol level
Fasting blood LDL cholesterol level by Ultracentrifugation method
Measured: Baseline (V1), Following 6 weeks of consumption (V2) and 6 weeks after the end of consumption (V4)
Evolution of Lipid profile
Triglycerides, Total-cholesterol, HDL-C, non-HDL-C, LDL-C, Free Fatty Acids, Apo-A1 and Apo-B, Apo-B/Apo-A1 ratio, Apo-C3
Measured: Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)
Evolution of Lipid homeostasis indices
Atherogenic index (ratio of triglycérides and HDL-C), atherogenic coefficient (ratio of total-cholesterol and HDL-C), cardiac risk ratio 1 (ratio of total-cholesterol and HDL-C), cardiac risk ratio 2 (ratio of LDL-C and HDL-C) (note that all these measures are unitless ratios)
Measured: Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)
Evolution of fasting glycemia
Fasting Glycemia (in mg/dL)
Measured: Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)
Evolution of Low grade inflammation
Fasting blood hsCRP, Interleukin-6
Measured: Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)
Evolution of body weight
Body weight (BW) in kg
Measured: Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)
Evolution of body mass index
Body mass index (BMI) in kg/m2
Measured: Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)
Evolution of waist circumference
Waist circumference (WC) in cm
Measured: Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)
Evolution of hip circumference
Hip circumference (HC) in cm
Measured: Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)
Evolution of waist to hip ratio
Waist to hip ratio (WHR)
Measured: Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start4 Oct 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A MULTICENTER, RANDOMIZED PLACEBO-CONTROLLED DOUBLE-BLINDED STUDY
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valbiotis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Menzel, MD, Principal investigator, Biotesys
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243484
- Sponsor's protocol ID
- VCT-013
- Other IDs
- BTS1876_22
- Acronym
- HEARTII
- Status last verified
- Apr 2024
- First submitted
- 19 Jan 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Investigate the Effect of the Food Supplement TOTUM-070 on Lipid Metabolism in Moderately Hypercholesterolemic Subjects After 3 Months of Supplementation
- ClinicalTrials.gov ID
- NCT06243484
- Acronym / sponsor ID
- HEARTII / VCT-013
- Conditions
- Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (actual)
- Lead sponsor
- ValbiotisIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 6 Feb 2024 (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.
This clinical trial is to confirm the effects of TOTUM-070, a mix of 5 plants extracts, consumed at the daily regimen of two times per day, on fasting blood LDL cholesterol concentrations in moderately hypercholesterolemic subjects after 12 weeks of consumption (V3).
Detailed description
The main objective is to confirm the efficacy of a 4.995g/day dose of TOTUM-070 versus placebo on fasting blood LDL cholesterol level (Ultracentrifugation (UC) method) in moderately hypercholesterolemic subjects following 12 weeks of consumption (V3).
The proposed double-blinded, placebo-controlled, clinical study will provide further insight into the safety and efficacy of TOTUM-070 at the same dose (4.995g/day) on a shorter supplementation period (3 months) than the previous one (6 months), as well as assess the effect after the follow-up period without product intake.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A MULTICENTER, RANDOMIZED PLACEBO-CONTROLLED DOUBLE-BLINDED STUDY
| Arm | Type | Receives |
|---|---|---|
| TOTUM-070 | Experimental | Dietary Supplement: TOTUM-070The experimental arm will be supplemented with TOTUM-070 twice a day |
| PLACEBO | Placebo comparator | Dietary Supplement: PLACEBOThe placebo comparator arm will be supplemented with a placebo twice a day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- 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 |
|---|---|---|
| TOTUM-070Also: Active product 2 intakes per day12 weeks of TOTUM-070 supplementation with Placebo (blinded arms) | Dietary supplement | TOTUM-070 |
| PLACEBOAlso: Comparator product 2 intakes per day8 capsules per day to consume orally in two intakes | Dietary supplement | PLACEBO |
Primary outcome
Evolution of fasting blood LDL cholesterol level
Time frame: Baseline (V1) and End of consumption after 12 weeks (V3)
Fasting blood LDL cholesterol level by Ultracentrifugation method
10 secondary outcomes
Evolution of fasting blood LDL cholesterol level
Time frame: Baseline (V1), Following 6 weeks of consumption (V2) and 6 weeks after the end of consumption (V4)
Evolution of Lipid profile
Time frame: Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)
Evolution of Lipid homeostasis indices
Time frame: Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)
Evolution of fasting glycemia
Time frame: Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)
Evolution of Low grade inflammation
Time frame: Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)
Evolution of body weight
Time frame: Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)
Evolution of body mass index
Time frame: Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)
Evolution of waist circumference
Time frame: Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)
Evolution of hip circumference
Time frame: Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)
Evolution of waist to hip ratio
Time frame: Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
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.
Daniel Menzel, MD principal investigator
Biotesys
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-070 in people with Hypercholesterolemia, run by Valbiotis at 1 site in Germany.
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: status not confirmed, as of the sponsor's last update on 1 Jul 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 Germany. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Evolution of fasting blood LDL cholesterol level (time frame: Baseline (V1) and End of consumption after 12 weeks (V3)). 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 1 Jul 2024.