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Gazzetta Medica Italiana - Archivio per le Scienze Mediche 2021 June;180(6):289-94

DOI: 10.23736/S0393-3660.21.04651-9

Copyright © 2021 EDIZIONI MINERVA MEDICA

language: English

Effects of different doses of Pycnogenol® on plasma oxidative stress: a pilot, supplement study

Gianni BELCARO 1, 2 , Maria R. CESARONE 1, 2, Mark DUGALL 1, 2, Shu HU 1, 2, Paula PETERZAN 1, 2, Beatrice FERAGALLI 1, 2, Morio HOSOI 1, 2, Roberto COTELLESE 1, 2

1 IRVINE3 Labs, Department of Oral and Medical Sciences and Biotechnologies, Chieti-Pescara University, Chieti, Italy; 2 IA-PSS: International Agency for Pharma-Standard Supplements, Pescara, Italy



BACKGROUND: The aim of this pilot study was to evaluate the dose-response efficacy of Pycnogenol® supplementation in reducing oxidative stress in subjects with high oxidative stress, without any significant disease or risk condition. Pycnogenol® is known to be effective in reducing oxidative stress associated with increased inflammatory markers in common inflammatory conditions.
METHODS: The 160 subjects included were supplemented with different doses of Pycnogenol® ranging from 30 mg, 50 mg, 100 mg, 150 mg to 200mg/day in 5 comparable groups for a period of 4 weeks.
RESULTS: Overall, 152 subjects completed the 4 week-study: 32 in the 30 mg group, 30 in the 50 mg group, 28 in the 100 mg group, 32 in the 150 mg group and 30 subjects in the 200 mg group. Plasma oxidative stress was assessed at pre-baseline two days before inclusion. A baseline measurement was made at inclusion. Measurements of oxidative stress after 4 weeks were made before 10 a.m. in fasting conditions. Routine blood tests were within the reference range at 4 weeks. Blood pressure, heart rate and thyroid tests were normal at inclusion and at the end of the study. After 4 weeks of Pycnogenol® intake, oxidative stress decreased significantly in all dose groups. The decrease in oxidative stress was dose dependent and was progressively more pronounced for doses from 30 mg to 200 mg/day. The highest dose of 200 mg daily caused the most significant decrease in oxidative stress of 28% compared to a decrease of 12% with 30 mg/day. Even the lowest dose (around 0.3-0.4 mg/kg of body weight/daily) produced a significant effect on oxidative stress. No side effects were observed. There was a good compliance and a very good tolerability for Pycnogenol®.
CONCLUSIONS: This pilot registry evaluated the effects of Pycnogenol® at increasing doses in subjects with high oxidative stress. There is a relationship between the decrease of oxidative stress and the increase of the Pycnogenol® dose. Pycnogenol® supplementation appears to safely control oxidative stress in subjects with high oxidative stress without any significant disease or risk condition. Even low doses produce an improvement in oxidative stress. This observation may be verified, considering clinical aspects and efficacy, under real clinical conditions, in longer and larger studies.


KEY WORDS: Pycnogenols; Oxidative stress; Drug dosage calculations

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