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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Dyslipidemias; Hypercholesterolemia; Hypertriglyceridemia; Postmenopausal Symptoms; Hyper-LDL-cholesterolemia; Hypo HDL Cholesterolaemia
• Intervention / Treatment: Drug: Placebo; Drug: Phytoestrogen

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Prischa Saengow, MD.; Phone Number: +66-65-2162299; Email: purnprattana@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; starch, no active substance	Drug: Placebo; consume 1 starch capsule twice a day for 2 months
Experimental: PM1; Pueraria mirifica 1 Subspecies: A Process/Extraction: C Planting location: E	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
Experimental: PM2; Pueraria mirifica 2 Subspecies: B Process/Extraction: C Planting location: F	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
Experimental: PM3; Pueraria mirifica 3 Subspecies: B Process/Extraction: D Planting location: G	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum lipid parameters	serum triglyceride, total cholesterol, LDL, HDL	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	mmHg	2 months
Body mass index(BMI) or body weight		2 months
waist circumference	cm	2 months
Menopause symptom score	Greene Climacteric Scale(GCS) minimum values= 0 , maximum values=63 , higher scores mean higher menopause symptom(worse outcome).	2 months

Collaborators and Investigators

• Sponsor: Dhurakij Pundit University
• Investigators: Principal Investigator: Prischa Saengow, MD., Dhurakij Pundit University

Publications and helpful links

General Publications

• [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).

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: January 14, 2024
• First Submitted That Met QC Criteria: January 14, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Dyslipidemia; Hypercholesterolemia; Postmenopausal women; Phytoestrogens; Hypertriglyceridemia; Postmenopausal Symptoms; Pueraria Mirifica; Hyper-LDL-cholesterolemia; Hypo HDL Cholesterolaemia; Randomized clinical trail
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Hypertriglyceridemia; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens, Non-Steroidal; Estrogens; Phytoestrogens
• Other Study ID Numbers: DPUHREC010/66FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Not sure yet whether it is possible to share but plan to up load all the record form and lab investigation if possible

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No