A randomized, double-blind, placebo-controlled crossover clinical trial to evaluate the anti-diabetic effects of Allium hookeri extract in the subjects with prediabetes

Soo-Hyun Park, Ui-Jin Bae, Eun-Kyung Choi, Su-Jin Jung, Sung-Hyen Lee, Jae-Heon Yang, You-Suk Kim, Do-Youn Jeong, Hyun-Ju Kim, Byung-Hyun Park, Soo-Wan Chae, Soo-Hyun Park, Ui-Jin Bae, Eun-Kyung Choi, Su-Jin Jung, Sung-Hyen Lee, Jae-Heon Yang, You-Suk Kim, Do-Youn Jeong, Hyun-Ju Kim, Byung-Hyun Park, Soo-Wan Chae

Abstract

Background: Allium hookeri is widely consumed as a vegetable and herbal medicine in Asia. A. hookeri has been reported anti-inflammatory, anti-obesity, osteoblastic, anti-oxidant, and anti-diabetic effects in animal studies. We investigated the anti-diabetic effects of A. hookeri aqueous extract (AHE) in the Korean subjects.

Methods: Prediabetic subjects (100 ≤ fasting plasma glucose (FPG) < 126 mg/dL) who met the inclusion criteria were recruited for this study. The enrolled subjects (n = 30) were randomly divided into either an AHE (n = 15, 486 mg/day) or placebo (n = 15) group. Outcomes were measurements of FPG, glycemic response to an oral glucose tolerance test (OGTT), insulin, C-peptide, hemoglobin A1c (HbA1c), total cholesterol, triglyceride, HDL-cholesterol, and LDL-cholesterol. The t-test was used to assess differences between the groups. A p-value < 0.05 was considered statistically significant.

Results: Eight weeks after AHE supplementation, HbA1c level was significantly decreased in the AHE group compared with the placebo group. No clinically significant changes in any safety parameter were observed.

Conclusion: The findings suggest that AHE can be effective in reducing HbA1c, indicating it as an adjunctive tool for improving glycemic control.

Trial registration: The study protocol was retrospectively registered at www.clinicaltrials.gov ( NCT03330366 , October 30, 2017).

Keywords: Allium hookeri; Hemoglobin A1c; Incremental area under the curve; Oral glucose tolerance test; Plasma glucose; Prediabetes.

Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Scheme of the crossover design
Fig. 2
Fig. 2
CONSORT diagram showing the study flow

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