Background <p>Tired and heavy legs are common venous complaints associated with both lifestyle factors and chronic venous insufficiency (CVI).</p> Methods <p>This randomized, double-blind, placebo-controlled, study was conducted with 122 healthy subjects experiencing heavy and tired legs and telangiectasia. Participants received one tablet per day of a food supplement containing 570&#xa0;mg of a formulated flavonoid complex (comprising 80% diosmin and a total flavonoid content of 90%) for 56 days. The control group included subjects with similar baseline characteristics, each receiving one tablet of placebo per day for the same duration. Assessment of leg discomfort, including sensations of heaviness and tiredness, as well as telangiectasia severity, skin color, and blood flow in the affected area, was conducted before (baseline or Day 0) and after 14 (D14), 28 (D28) and 56 (D56) days of supplementation. Additional evaluations included subjective perception of product effectiveness.</p> Results <p>By D56, significant improvements were recorded: sensation of heavy legs decreased by 41.7% (<i>p</i> &lt; 0.05), while the sensation of tired legs decreased by 45.2% (<i>p</i> &lt; 0.01). The number of responders in the active group was approximately twice compared to the placebo group. Participants also reported a positive perception of the product’s efficacy, and the treatment was well-tolerated.</p> Conclusions <p>These findings suggest that the tested food supplement provides beneficial effects in alleviating symptoms of heavy and tired legs.</p> Trial registration <p>ISRCTN15667863, date of registration14/01/2025.</p>

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A nutraceutical intervention for alleviating tired and heavy legs in healthy subjects: a randomized, double-blind, controlled study

  • Vincenzo Nobile,
  • Enza Cestone,
  • Gloria Roveda

摘要

Background

Tired and heavy legs are common venous complaints associated with both lifestyle factors and chronic venous insufficiency (CVI).

Methods

This randomized, double-blind, placebo-controlled, study was conducted with 122 healthy subjects experiencing heavy and tired legs and telangiectasia. Participants received one tablet per day of a food supplement containing 570 mg of a formulated flavonoid complex (comprising 80% diosmin and a total flavonoid content of 90%) for 56 days. The control group included subjects with similar baseline characteristics, each receiving one tablet of placebo per day for the same duration. Assessment of leg discomfort, including sensations of heaviness and tiredness, as well as telangiectasia severity, skin color, and blood flow in the affected area, was conducted before (baseline or Day 0) and after 14 (D14), 28 (D28) and 56 (D56) days of supplementation. Additional evaluations included subjective perception of product effectiveness.

Results

By D56, significant improvements were recorded: sensation of heavy legs decreased by 41.7% (p < 0.05), while the sensation of tired legs decreased by 45.2% (p < 0.01). The number of responders in the active group was approximately twice compared to the placebo group. Participants also reported a positive perception of the product’s efficacy, and the treatment was well-tolerated.

Conclusions

These findings suggest that the tested food supplement provides beneficial effects in alleviating symptoms of heavy and tired legs.

Trial registration

ISRCTN15667863, date of registration14/01/2025.