Written by Taylor Woosley, Science Writer. 12-week supplementation with 1150 mg of KM daily reduced hot flash severity by 40% and resulted in a significant and negative impact on two bone resorption markers CTx (β=-0.05, p=0.027) and NTx (β=-0.80) compared to placebo.
Menopause is typically defined after amenorrhea of 12 months in a woman aged 45 years or older1. Physiological and metabolic changes associated with menopause include a direct effect of estrogen deficiency, which has been shown to affect lipid metabolism, energy consumption, insulin resistance, and body fat composition2. Furthermore, decline in circulating estrogen levels causes a rapid acceleration in bone loss, with an average decrease in bone mineral density (BMD) at about 10% during the menopausal transition3.
Kudzu flower extract contain isoflavones that are classified as phytoestrogens and induce weak estrogen-like effects4. Furthermore, mandarin peel features high levels of flavonoids such as naringin, rutin, and hesperidin, which are reported to exert various bioactive activities such as antioxidant and anti-inflammatory activities5. Flavonoids have a beneficial effect on bone cell metabolism, contributing to the prevention of bone diseases, such as osteoarthritis and osteoporosis6.
Kim et al. conducted a randomized controlled parallel design with two arms of a fixed-dose of KM or matching placebo to evaluate the efficacy and safety of an extract mixture of kudzu flower and mandarin peel (KM) on modulating hot flashes and bone turnover markers in peri- and post-menopausal women. Subject inclusion consisted of peri- and post-menopausal women aged 45 to 60 years experiencing menopausal hot flashes (HFs) based on the Kupperman Index (KI) ≥15 and an average daily HF score ≥10 for 1 week before the screening visit. 84 participants were assigned to either the KM group (n=42) or the placebo (n=42) and were instructed to consume three capsules once a day for 12 weeks. The KM capsules contained 383.4 mg of KM, with 70.3 mg/g of three tectorigenin derivatives and 51.7 mg/g hesperidin for a total of 1150 mg KM per day. The placebo capsule contained lactose in place of KM.
Subjects were informed to maintain normal diet and lifestyle practices throughout the trial but to refrain from consuming kudzu, mandarin peel, citrus, calcium, and isoflavone-rich foods. At baseline and weeks 6 and 12, all participants completed dietary intakes and the International Physical Activity Questionnaire (IPAQ). Additionally, the Pittsburgh Sleep Quality Index (PSQI) and Recommended Food Scores were measured at baseline and week 12. Fasted blood samples were obtained at baseline and week 12 to analyze levels of osteocalcin (OC), plasma C-telopeptide fragment (CTx), plasma N-telopeptide fragment (NTx), serum bone-specific alkaline phosphatase (BALP), estradiol, follicle stimulating hormone (FSH), and luteinizing hormone (LH). Hot flash occurrence was monitored via a daily diary completed by subjects over 12 weeks. Frequency and severity of menopausal symptoms was measured using the KI and Menopause-Specific Quality of Life Questionnaire (MenQOL) at baseline and end of intervention.
Student’s t-test for continuous variables and chi-squared or Fisher’s exact test for categorical variables was utilized to test differences in baseline characteristics between groups. Linear regression models were used to analyze the associations between HF scores or HF severity and bone turnover markers. 76 subjects were included in the final analysis. No significant differences were noted between the KM and placebo groups regarding age, KI scores, and HF scores. The mean age was 51.8 ± 0.4 years, with a KI of 24.7 and a HF score of 31.3. Significant findings of the study are as follows:
- At 12 weeks, both the HF scores (p=0.041) and HF severity (p<0.001) were significantly lower in the KM group compared to placebo. Furthermore, HF scores decreased by 60.1% and HF severity decreased by 40% in the KM group compared to placebo from the baseline.
- The KM group experienced a significant and negative impact on two bone resorption markers CTx (β=-0.05, p=0.027) and NTx (β=-0.80) compared to placebo.
- Difference in OC levels in the KM group from baseline to end of intervention were deemed statistically significant (p=0.001).
Results of the randomized controlled trial show that 12-week supplementation with KM significantly improved HF scores and severity, while also improving bone turnover markers. KM administration may be an effective method for improving symptoms associated with the menopausal transition. Study limitations include not measuring levels of serum serotonin, epinephrine, and the levels of RANKL gene expression.
Source: Kim, Ji Eon, Hyeyun Jeong, Soohee Hur, Junho Lee, and Oran Kwon. “Efficacy and safety of kudzu flower–mandarin peel on hot flashes and bone markers in women during the menopausal transition: A randomized controlled trial.” Nutrients 12, no. 11 (2020): 3237.
© 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
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Posted March 27, 2024.
Taylor Woosley studied biology at Purdue University before becoming a 2016 graduate of Columbia College Chicago with a major in Writing. She currently resides in Glen Ellyn, IL.
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- Tousen Y, Takebayashi J, Kondo T, et al. Safety and Efficacy Assessment of Isoflavones from Pueraria (Kudzu) Flower Extract in Ovariectomised Mice: A Comparison with Soy Isoflavones. Int J Mol Sci. Jun 12 2019;20(12)doi:10.3390/ijms20122867
- Lee S, Kim HJ. Antioxidant activities of premature and mature mandarin (Citrus unshiu) peel and juice extracts. Food Sci Biotechnol. May 2022;31(5):627-633. doi:10.1007/s10068-022-01064-5
- Ortiz AC, Fideles SOM, Reis CHB, et al. Therapeutic Effects of Citrus Flavonoids Neohesperidin, Hesperidin and Its Aglycone, Hesperetin on Bone Health. Biomolecules. Apr 23 2022;12(5)doi:10.3390/biom12050626