Format

Send to

Choose Destination
Food Chem Toxicol. 2017 Oct;108(Pt B):519-523. doi: 10.1016/j.fct.2016.11.021. Epub 2016 Nov 24.

Safety assessment of 4-week oral intake of proanthocyanidin-rich grape seed extract in healthy subjects.

Author information

1
Research and Development Division, Kikkoman Corporation, 399 Noda, Noda-shi, Chiba 278-0037, Japan. Electronic address: asano@mail.kikkoman.co.jp.

Abstract

A clinical study was conducted to assess the safety and tolerability of oral doses of proanthocyanidin-rich grape seed extract (GSE) in healthy Japanese adult volunteers. In an open-label, 4-week toxicity test, 29 subjects daily received 1000, 1500, or 2500 mg GSE orally. Serum Fe levels of two subjects in the 2500 mg GSE group decreased to 61 and 60 μg/100 mL from 205 and 182 μg/100 mL at baseline respectively, at second week of GSE consumption; these values are low but within the normal range for the Japanese population. Two weeks after completing the 4-week course of GSE ingestion, the serum Fe levels of both subjects returned to near baseline levels (210 and 189 μg/100 mL). No subject discontinued the study. Oral intake of GSE up to 2500 mg for 4 weeks was found to be generally safe and well tolerated in humans. Research with a larger number of subjects is required to confirm these findings.

KEYWORDS:

Clinical study; Grape seed extract; Proanthocyanidin; Safety; Tolerability

PMID:
27889390
DOI:
10.1016/j.fct.2016.11.021
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center