NCT05594979

Brief Summary

This clinical study aims to assess the efficacy of 6 weeks 2.5g dose of TOTUM-070, a mix of 5 plant extracts, on lipid metabolism and cardiovascular health in individuals at increased cardio-metabolic risk.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 26, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

December 14, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2023

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

9 months

First QC Date

October 21, 2022

Last Update Submit

February 7, 2024

Conditions

HypercholesterolemiaCardiovascular Risk FactorDyslipidemiasAtherosclerosisCardio-metabolic Risk

Keywords

Moderate hypercholesterolemiaNutrition healthcarePlant extracts

Outcome Measures

Primary Outcomes (1)

  • Change from baseline of blood LDL cholesterol concentration at 6 weeks

    LDL cholesterol (Friedewald method)

    V1 (baseline) and V2 (6 weeks of intervention)

Secondary Outcomes (7)

  • Change from baseline of the fasting blood concentration of triglycerides

    V1 (baseline) and V2 (6 weeks of intervention)

  • Change from baseline of the fasting blood concentration of total cholesterol

    V1 (baseline) and V2 (6 weeks of intervention)

  • Change from baseline of the fasting blood concentration of HDL cholesterol

    V1 (baseline) and V2 (6 weeks of intervention)

  • Change from baseline of the fasting blood concentration of non-HDL cholesterol

    V1 (baseline) and V2 (6 weeks of intervention)

  • Change from baseline of the fasting blood concentration of free fatty acids

    V1 (baseline) and V2 (6 weeks of intervention)

  • +2 more secondary outcomes

Study Arms (1)

TOTUM-070

EXPERIMENTAL

Experimental active diet supplement TOTUM-070 taken 2 times per day

Dietary Supplement: TOTUM-070

Interventions

TOTUM-070DIETARY_SUPPLEMENT

2.5-g dose of TOTUM-070 diet supplement; Four capsules per day to consume orally in two intakes

TOTUM-070

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index (BMI) between 18.5 and 35 kg/m²
  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIC Clermont Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

HypercholesterolemiaDyslipidemiasAtherosclerosis

Condition Hierarchy (Ancestors)

HyperlipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2022

First Posted

October 26, 2022

Study Start

December 14, 2022

Primary Completion

September 6, 2023

Study Completion

September 27, 2023

Last Updated

February 9, 2024

Record last verified: 2024-02

Locations

FR(1)