Effects of Phytoestrogen From Pueraria Mirifica in Improvement of Serum Lipid Parameters in Postmenopausal Women

Hypercholesterolemia Clinical Trial

Official title:

Effects of Phytoestrogen From Pueraria Mirifica in Improvement of Serum Lipid Parameters in Postmenopausal Women: Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06220266
• Other study ID #: DPUHREC010/66FB
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: March 2, 2024
• Est. completion date: November 2024

Study information

• Verified date: April 2024
• Source: Dhurakij Pundit University
• Contact: Prischa Saengow, MD.
• Phone: +66-65-2162299
• Email: purnprattana[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to learn about the effects of phytoestrogen from Pueraria Mirifica in improvement of serum lipid parameters. The primary question it aims to answer are: • phytoestrogen from Pueraria Mirifica can reduce serum triglyceride, total cholesterol, LDL and increase HDL or not Participants will receive capsules which composed of dry weight 50 mg of Pueraria Mirifica twice a day for 2 months. Researchers will compare with starch capsules to see if there is the improvement of serum lipid parameters

Description:

The secondary question it aims to answer are: - phytoestrogen from Pueraria Mirifica can reduce menopausal symptom score or not - phytoestrogen from Pueraria Mirifica can reduce body mass index(BMI) or not - phytoestrogen from Pueraria Mirifica can reduce waist circumference or not - phytoestrogen from Pueraria Mirifica can reduce blood pressure or not - phytoestrogen from Pueraria Mirifica effects to creatinine, BUN, eGFR or not - phytoestrogen from Pueraria Mirifica effects liver function enzymes or not

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: November 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Natural menopause, last menstrual period more than one year ago.

2. Abnormal lipid profile parameters The criteria set for this research are:

• LDL>130 mg/Dl or
• TG>150 mg/Dl or
• Total cholesterol>200 mg/Dl or
• HDL-C less than 50 mg/Dl. (Latest blood results not more than 6 months If the blood results are more than 3 months, a new blood test will be done.)

3. Willing to participate in the project

Exclusion Criteria:

1. Have ever received lipid-lowering medication or hormone replacement therapy or SERMs. During the past 6 weeks

2. have had surgery on the ovaries or uterus before

3. have a history of cancer within a 5-year period

4. have diabetes or uncontrolled high blood pressure, including HbA1c >9, Systolic blood pressure >180 or Diastolic blood pressure >110

5. Endocrine system disease such as thyroid

6. Ever had an organ transplant

7. Regularly use drugs, marijuana, or drink alcohol.

8. has a psychiatric disorder

9. have other serious medical conditions that require close monitoring

10. Inconvenient to follow up until the end of the research.

Related Conditions & MeSH terms

• Dyslipidemias
• Hyper-LDL-cholesterolemia
• Hypercholesterolemia
• Hypertriglyceridemia
• Postmenopausal Symptoms

Intervention

Drug:
• Phytoestrogen
consume 1 capsule twice a day for 2 months which one capsule composed of dry weight 50 mg of Pueraria Mirifica 1or Pueraria Mirifica 2 or Pueraria Mirifica 3
• Placebo
consume 1 starch capsule twice a day for 2 months

Locations

Country	Name	City	State
Thailand	Dhurakij Pundit University	Laksi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Dhurakij Pundit University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

[1] World Health Organization . Geneva: World Health Organization; c2019. Global Health Observatory (GHO) data [Internet] [cited 2019 Jun 20]. Available from: http://www.who.int/gho/ncd/mortality_morbidity/ncd_total/en/index.html. [Google Scholar] [2] World Health Organization . Geneva: World Health Organization; c2019. Preventing chronic diseases: a vital investment [Internet] [cited 2019 Jun 20]. Available from: http://www.who.int/chp/chronic_disease_report/en. [Google Scholar] [3] Rhee EJ, Kim HC, Kim JH, et al. 2018 Guidelines for the management of dyslipidemia [published correction appears in Korean J Intern Med. 2019 Sep;34(5):1171]. Korean J Intern Med. 2019;34(4):723-771. doi:10.3904/kjim.2019.188 [4] Xi Y, Niu L, Cao N, et al. Prevalence of dyslipidemia and associated risk factors among adults aged =35 years in northern China: a cross-sectional study. BMC Public Health. 2020;20(1):1068. Published 2020 Jul 6. doi:10.1186/s12889-020-09172-9 [5] Ambikairajah, Ananthan BSc, MTeach, PhDc; Walsh, Erin PhD; Cherbuin, Nicolas PhD. Lipid profile differences during menopause: a review with meta-analysis. Menopause 26(11):p 1327-1333, November 2019. DOI: 10.1097/GME.0000000000001403 [6] Liang J, & Shang Y (2013). Estrogen and cancer. Annu Rev Physiol, 75, 225-240. [7] Blaustein JD 2008 An estrogen by any other name. Endocrinology 149:2697-2698 [8] Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA.2002;288:321-333. [9] Sookvanichsilp N, Soonthornchareonnon N, Boonleang C. Estrogenic activity of the dichloromethane extract from Pueraria mirifica. Fitoterapia. 2008 Dec;79(7-8):509-14. doi: 10.1016/j.fitote.2008.05.006. Epub 2008 Jun 22. PMID: 18621111. [10] Peacock K, Ketvertis KM. Menopause. [Updated 2022 Aug 11]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK507826/ [11] Pappan N, Rehman A. Dyslipidemia. [Updated 2022 Jul 11]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK560891/ [12] Menazza S, Murphy E. The Expanding Complexity of Estrogen Receptor Signaling in the Cardiovascular System. Circ Res. 2016 Mar 18;118(6):994-1007. doi: 10.1161/CIRCRESAHA.115.305376. Epub 2016 Jan 7. PMID: 26838792; PMCID: PMC5012719. [13] Rossella E Nappi, et al. Menopause: a cardiometabolic transition. Lancet Diabetes Endocrinol. 2022 Jun;10(6):442-456. doi: 10.1016/S2213-8587(22)00076-6. [14] Hester M. den Ruijter, Georgios Kararigas. Estrogen and Cardiovascular Health. Front. Cardiovasc. Med., 2022 March 30:9 Sec. Sex and Gender in Cardiovascular Medicinehttps://doi.org/10.3389/fcvm.2022.886592 [15] Moskowitz D. A comprehensive review of the safety and efficacy of bioidentical hormones for the management of menopause and related health risks. Altern Med Rev. 2006 Sep;11(3):208-23. PMID: 17217322. [16] Holtorf K. The bioidentical hormone debate: are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy? Postgrad Med. 2009 Jan;121(1):73-85. doi: 10.3810/pgm.2009.01.1949. PMID: 19179815. [17] Howlader N, Altekruse SF, Li CI, Chen VW, Clarke CA, Ries LA, et al. US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status. J Natl Cancer Inst. 2014;106:dju055 [18] WHO launches new roadmap on breast cancer. World Health Organization. Updated at February 3, 2023. Access September 9, 2023. https://www.who.int/news/item/03-02-2023-who-launches-new-roadmap-on-breast-cancer [19] Yue W, Wang JP, Li Y, Fan P, Liu G, Zhang N, Conaway M, Wang H, Korach KS, Bocchinfuso W, Santen R. Effects of estrogen on breast cancer development: Role of estrogen receptor independent mechanisms. Int J Cancer. 2010 Oct 15;127(8):1748-57. doi: 10.1002/ijc.25207. PMID: 20104523; PMCID: PMC4775086. [20] Martinkovich, Stephen & Shah, Darshan & Lobo, Sonia & Arnott, John. (2014). Selective estrogen receptor modulators: Tissue specificity and clinical utility. Clinical Interventions in Aging. 4. 1437. 10.2147/CIA.S66690. [21] Pickar JH, Komm BS (Sep 2015).

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum lipid parameters	serum triglyceride, total cholesterol, LDL, HDL	2 months
Secondary	Menopause symptom score	Greene Climacteric Scale(GCS) minimum values= 0 , maximum values=63 , higher scores mean higher menopause symptom(worse outcome).	2 months
Secondary	Blood Pressure	mmHg	2 months
Secondary	Body mass index(BMI) or body weight		2 months
Secondary	waist circumference	cm	2 months
Secondary	kidney function	Creatinine, BUN, eGFR	2 months
Secondary	liver enzymes	AST, ALT	2 months