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

NCT06220266 | Recruiting Phase 2

• 1 other identifier: DPUHREC010/66FB
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 diet control\&life style modification to see if there is the improvement of serum lipid parameters

Conditions

Dyslipidemias; Hypertriglyceridemia; Hypercholesterolemia; Hyper-LDL-cholesterolemia; Hypo HDL Cholesterolaemia; Postmenopausal Symptoms

Keywords

Phytoestrogens; Pueraria Mirifica; Postmenopausal women; Dyslipidemia; Hypertriglyceridemia; Hypercholesterolemia; Hyper-LDL-cholesterolemia; Hypo HDL Cholesterolaemia; Postmenopausal Symptoms; Randomized clinical trail

Outcome Measures

Primary Outcomes (1)

• Serum lipid parameters

  serum triglyceride, total cholesterol, LDL, HDL

  2 months

Secondary Outcomes (6)

• Menopause symptom score

  2 months

• Blood Pressure

  2 months

• Body mass index(BMI) or body weight

  2 months

• waist circumference

  2 months

• kidney function

  2 months

Study Arms (2)

Diet control & life style modification

PLACEBO COMPARATOR

Diet control \& life style modification

Drug: Diet control & life style modification

PM

EXPERIMENTAL

Pueraria mirifica

Drug: Phytoestrogen

Interventions

Phytoestrogen DRUG

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

PM

Diet control & life style modification DRUG

Diet control \& life style modification

Diet control & life style modification

Eligibility Criteria

• Gender Eligibility Details: Postmenopausal women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Natural menopause, last menstrual period more than one year ago.
• 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)
• Willing to participate in the project

You may not qualify if:

• Have ever received lipid-lowering medication or hormone replacement therapy or SERMs. During the past 6 weeks
• have had surgery on the ovaries or uterus before
• have a history of cancer within a 5-year period
• have diabetes or uncontrolled high blood pressure, including HbA1c \>9, Systolic blood pressure \>180 or Diastolic blood pressure \>110
• Endocrine system disease such as thyroid
• Ever had an organ transplant
• Regularly use drugs, marijuana, or drink alcohol.
• has a psychiatric disorder
• have other serious medical conditions that require close monitoring
• Inconvenient to follow up until the end of the research.

Sponsors & Collaborators

• Dhurakij Pundit University: lead

Study Sites (1)

Dhurakij Pundit University

Laksi, Bangkok, 10210, Thailand

RECRUITING

Related 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).

  BACKGROUND

MeSH Terms

Conditions

Dyslipidemias; Hypertriglyceridemia; Hypercholesterolemia

Interventions

Phytoestrogens

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperlipidemias

Intervention Hierarchy (Ancestors)

Estrogens, Non-Steroidal; Estrogens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Prischa Saengow, MD.

  Dhurakij Pundit University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prischa Saengow, MD.

CONTACT

+66-65-2162299; purnprattana@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Unmasked due to patient preference trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Model Details: Patient preference trial

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: January 23, 2024
• Study Start: March 2, 2024
• Primary Completion: August 1, 2024
• Study Completion: November 1, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

TH (1)