Randomised, double-blind, parallel group comparison of Ashitaba (Angelica Keiskei) chalcone effects on visceral fat areas and waist circumference of overweight persons

Abstract

This randomised, placebo-controlled, double-blind, parallel-group study aimed to determine whether encapsulated Ashitaba chalcone (16 mg comprising 10.1 mg 4-hydroxyderricin and 5.9 mg xanthoangelol) could reduce obesity in 17 men and 25 women with a body mass index (BMI) of 25 to < 30. Participants ingested capsules containing either the chalcone or a placebo daily for 12 weeks. The primary endpoint was changes in visceral fat areas determined by computed tomography (CT) at baseline, and at 8 and 12 weeks later. The primary endpoint, abdominal visceral fat area, was significantly reduced in the chalcone, compared with a placebo group 12 weeks after screening (p < 0.05). The secondary endpoint, waist circumference, was significantly decreased in the chalcone, compared with the placebo group at weeks 8 and 12 (p < 0.05 at week 8; p < 0.01 at week 12). Therefore, Ashitaba chalcone has anti-obesity benefits for overweight men and women.

Keywords:

• 4-Hydroxyderricin
• xanthoangelol
• obese
• visceral fat area
• waist circumference

Author contributions

All authors contributed to the interpretation of the results, and reviewed and approved the final manuscript.

Clinical trials registry

The clinical trial has been pre-registered as UMIN ID: UMIN000023988 (University Medical Information-Network-Clinical Trials Registry [UMIN-CTR], https://www.umin.ac.jp/ctr/

Compliance with ethics of experimentation

The Miyawaki Orthopaedics Clinic IRB approved this randomised, placebo-controlled, double-blind, parallel-group study (Approval date: July 25, 2016) that proceeded at Fukuhara Clinic under physician supervision according to the Ethical Guidelines for Medical Research Involving Human Participants published by the World Medical Association and the Declaration of Helsinki (2013 amendment).

Consent

Volunteers recruited from the public (by New Drug Research Centre, Inc., Hokkaido, Japan) received written and oral explanations of the purpose, methods, and anticipated side effects of the study. Thereafter, 72 of them provided written informed consent to participate in the study.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

This work was supported by Japan Biological Science Laboratory Co., Ltd., which provided funding and chalcone. The Japan Biological Science Laboratory Co., Ltd. was not involved in the conduct of the clinical study or data analysis.