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Toxicol Rep. 2018 Oct 9;5:1021-1031. doi: 10.1016/j.toxrep.2018.10.007. eCollection 2018.

Toxicological assessment of Xanthigen® nutraceutical extract combination: Mutagenicity, genotoxicity and oral toxicity.

Author information

1
Nektium Pharma SL, Las Palmas, Spain.
2
Facultad de Ciencias de La Salud, Universidad de Las Palmas de Gran Canaria (ULPGC), Las Palmas, Spain.
3
NOVAREX Co., Ltd. Ochang, Chungbuk, 363-885, Republic of Korea.
4
P.L. Thomas & Co., Inc., NJ 07960, USA.

Abstract

Xanthigen® is a nutraceutical combination for weight management capable of increasing energy expenditure via uncoupling protein 1 (UCP-1) in white adipose tissue. It consists of brown seaweed Undaria pinnatifida extract, rich in the carotenoid fucoxanthin (FX) and pomegranate seed oil (PSO), rich in punicic acid. Xanthigen was screened to determine its genotoxicity and 90-days repeated oral toxicity. Genotoxicity was assessed with the Ames test (TA89, TA100, TA1535, TA1537, WP2), chromosomal aberration assay (Chinese hamster ovary cells) and mammalian micronucleus test (in mice). Xanthigen did not exhibit genotoxicity in any tested strain. Sub-chronic toxicity was evaluated with daily oral administration of 250, 500 and 1000 mg/kg/day doses of Xanthigen® to Sprague-Dawley rats over 90 days. No deaths and no deleterious effects were observed during the 90-day treatment, indicating an absence of sub-chronic toxicity and a no observed adverse effect level greater than 1000 mg/kg/day. A statistically significant decrease in bodyweight and food intake in Xanthigen® treated groups was attributed to the weight loss property of Xanthigen®. Overall, Xanthigen® shows no significant mutagenic or toxic effects.

KEYWORDS:

BSE, brown seaweed extract; CPA, cytophosphadine; DMSO, dimethyl sulfoxide; FX, fucoxanthin; Functional foods; Genotoxicity; KFDA, Korean Food and Drug Administration; LD50, oral lethal dose 50%; MMC, mitomycin; MNPCEs, micronucleated polychromatic erythrocytes; MUFA, monounsaturated fatty acids; NCE, normochromatic erythrocytes; NOAEL, no observed adverse effect level; Nutraceutical; Oral toxicity; PCE, polychromatic erythrocytes; PSO, pomegranate seed oil; PUFA, polyunsaturated fatty acid; RCC, relative cell count; S9, metabolic activation system consisting of liver-derived cell extract; SFA, saturated fatty acids; SPF, specific pathogenic free; Xanthigen

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