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Background/Objective <p>Hypercholesterolemia is a well-known risk factor for cardiovascular disease. This clinical trial evaluated the effects of TOTUM-070, a polyphenol-rich blend of plant extracts, on lipid metabolism in individuals with moderate hypercholesterolemia.</p> Subjects/Methods <p>This was a 6-month, multicenter, randomized, double-blind, placebo-controlled trial. Individuals not receiving lipid-lowering treatment and with fasting low-density lipoprotein cholesterol (LDL-C) between 1.3 and 1.9 g/L received TOTUM-070 (5 g/day) or placebo. The primary outcome was the change in fasting LDL-C. Secondary endpoints included safety, changes in the lipid profile, anthropometric measurements, and gut microbiome composition.</p> Results <p>A total of 120 subjects (mean age:53.1 ± 10.3 years; BMI: 25.9 ± 3.7 kg.m<sup>2</sup>; 69.2% women; baseline LDL-C: 1.44 ± 0.23 g/L) were included and randomized. TOTUM-070 was well tolerated. After 6 months, fasting LDL-C was reduced in the TOTUM-070 group compared with the placebo group (Mean estimate: 1.31 ± 0.03 [1.25 ; 1.37] vs 1.41 ± 0.03 [1.35 ; 1.47], <i>p</i> = 0.0041). Compared with placebo, TOTUM-070 also reduced total cholesterol (<i>p</i> &lt; 0.01), non-high-density lipoprotein cholesterol (non-HDL-C) (<i>p</i> &lt; 0.001), triglycerides (<i>p</i> &lt; 0.05), apolipoprotein (apo)B100 (<i>p</i> &lt; 0.01), the apoB100/apoA1 ratio (<i>p</i> &lt; 0.01), oxidized LDL (<i>p</i> &lt; 0.05), and body weight (–1.4 kg; <i>p</i> &lt; 0.001). Furthermore, a decrease in the abundance of <i>Dorea</i> in fecal samples was observed in the TOTUM-070 group.</p> Conclusions <p>This clinical trial showed that supplementation with TOTUM-070 significantly lowers LDL-C and improves other lipid parameters in subjects with moderate hypercholesterolemia. As a polyphenol-rich plant-based blend, TOTUM-070 represents a promising non-pharmacological strategy that could complement lifestyle modifications for the management of early-stage hypercholesterolemia.</p>

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Effect of a polyphenol-rich extract on LDL cholesterol in mild to moderate hypercholesterolemia: a randomized, double-blind, placebo-controlled trial

  • 期刊论文

  • 发表日期：

    2025年12月24日

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  • Pascal Sirvent,
  • Cedric Langhi,
  • Marie Vallier,
  • Arsênio Rodrigues Oliveira,
  • Mikael Croyal,
  • Yolanda F. Otero,
  • Vivien Chavanelle,
  • Arnaud Michaux,
  • Maxime Bargetto,
  • Florian Le Joubioux,
  • Thierry Maugard,
  • Murielle Cazaubiel,
  • Annie Bouchard-Mercier,
  • Véronique Sapone,
  • Bruno Pereira,
  • Frédéric Dutheil,
  • Sebastien L. Peltier,
  • Jean-Marie Bard

摘要

Background/Objective

Hypercholesterolemia is a well-known risk factor for cardiovascular disease. This clinical trial evaluated the effects of TOTUM-070, a polyphenol-rich blend of plant extracts, on lipid metabolism in individuals with moderate hypercholesterolemia.

Subjects/Methods

This was a 6-month, multicenter, randomized, double-blind, placebo-controlled trial. Individuals not receiving lipid-lowering treatment and with fasting low-density lipoprotein cholesterol (LDL-C) between 1.3 and 1.9 g/L received TOTUM-070 (5 g/day) or placebo. The primary outcome was the change in fasting LDL-C. Secondary endpoints included safety, changes in the lipid profile, anthropometric measurements, and gut microbiome composition.

Results

A total of 120 subjects (mean age:53.1 ± 10.3 years; BMI: 25.9 ± 3.7 kg.m2; 69.2% women; baseline LDL-C: 1.44 ± 0.23 g/L) were included and randomized. TOTUM-070 was well tolerated. After 6 months, fasting LDL-C was reduced in the TOTUM-070 group compared with the placebo group (Mean estimate: 1.31 ± 0.03 [1.25 ; 1.37] vs 1.41 ± 0.03 [1.35 ; 1.47], p = 0.0041). Compared with placebo, TOTUM-070 also reduced total cholesterol (p < 0.01), non-high-density lipoprotein cholesterol (non-HDL-C) (p < 0.001), triglycerides (p < 0.05), apolipoprotein (apo)B100 (p < 0.01), the apoB100/apoA1 ratio (p < 0.01), oxidized LDL (p < 0.05), and body weight (–1.4 kg; p < 0.001). Furthermore, a decrease in the abundance of Dorea in fecal samples was observed in the TOTUM-070 group.

Conclusions

This clinical trial showed that supplementation with TOTUM-070 significantly lowers LDL-C and improves other lipid parameters in subjects with moderate hypercholesterolemia. As a polyphenol-rich plant-based blend, TOTUM-070 represents a promising non-pharmacological strategy that could complement lifestyle modifications for the management of early-stage hypercholesterolemia.