Effects of 6 Weeks TOTUM-070 on Lipid Metabolism and Cardiovascular Health in Individuals at Increased Cardio-metabolic Risk
NCT ID: NCT05594979
Last Updated: 2024-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
31 participants
INTERVENTIONAL
2022-12-14
2023-09-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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TOTUM-070
Experimental active diet supplement TOTUM-070 taken 2 times per day
TOTUM-070
2.5-g dose of TOTUM-070 diet supplement; Four capsules per day to consume orally in two intakes
Interventions
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TOTUM-070
2.5-g dose of TOTUM-070 diet supplement; Four capsules per day to consume orally in two intakes
Eligibility Criteria
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Inclusion Criteria
* Moderate hypercholesterolemic subject without any clinical symptoms of hypercholesterolemia (xanthoma, recurrent chest and/or leg pain…) and not requiring immediate pharmacological lipid-lowering treatment according to the current recommendations (European Society of Cardiology /European Atherosclerosis Society, 2019)
* Fasting blood LDL cholesterol level (using Friedewald estimation method) between 1.3 and 1.9 g/L
* Fasting blood triglycerides level ≤ 2.2 g/L
Exclusion Criteria
* Suffering from an uncontrolled arterial hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg)
* With a history of ischemic cardiovascular event
* Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, ongoing hepatic or biliary disorders, chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble, etc.) or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator (e.g. celiac disease)
* Fasting glucose plasma concentration \> 1.26 g/L
18 Years
70 Years
ALL
Yes
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Valbiotis
INDUSTRY
Responsible Party
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Locations
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CIC Clermont Ferrand
Clermont-Ferrand, , France
Countries
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Other Identifiers
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2022-A01474-39
Identifier Type: OTHER
Identifier Source: secondary_id
VCT-015
Identifier Type: -
Identifier Source: org_study_id
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