Effects of a New Botanical Extracts Combination on Quality of Life in Menopausal Spanish Women

Quality of Life Clinical Trial

Official title:

Study on the Effect of a Nutritional Supplement With Isoflavones on the Symptoms of Climacteric in Healthy Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04381026
• Other study ID #: PRO_WH_HCT_2016.01
• Status: Completed
• Phase: N/A
• Start date: April 19, 2017
• Est. completion date: July 10, 2018

Study information

• Verified date: May 2020
• Source: Nektium Pharma SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was designed to evaluate the beneficial effects and safety of a standardised botanical extract combination containing soy isoflavone extract, grains of paradise seed dry extract and pomegranate skin dry extract on health-related Quality of Life in healthy Spanish menopausal women with hot flashes, anxiety, and depressive symptoms using the self reported and validated Cervantes Scale.

Description:

Fifty-seven outpatient women (45-65 years) with menstrual problems associated with climacteric syndrome were enrolled from April 2018 to April 2019 in the context of a prospective, placebo-controlled, double-blind study. Women were randomized to receive treatment with either the botanical combination (250 mg daily divided into two doses) or placebo for eight weeks. At the beginning and end of the study, health-related Quality of Life was assessed using the Cervantes Scale.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: July 10, 2018
• Est. primary completion date: June 6, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 55 Years

Eligibility

Inclusion Criteria:

• Women in the Climacteric Phase under medical criteria based on Health questionnaire, Blood and urine test.

• Informed consent to participate in the study.

Exclusion Criteria:

• Hormone-related pathologies.

• Menopause from surgery origin.

• Family or personal history of endocrine cancer.

• Known hypersensitivity to gluten, soybeans, soy protein, dairy products, pomegranate or grains of paradise.

• Vegetarian diet or daily consumption of soya rich-products during the last year.

• Anovulatory treatment.

• Hormone replacement treatment.

Related Conditions & MeSH terms

• Dietary Supplements
• Menopause
• Quality of Life

Intervention

Dietary Supplement:
• Botanical dry extracts combination
Aframomum melgueta dry extract (50mg), Glycine max bean dry extract (100mg) and Punica granatum skin extract (100mg)
• Placebo
Filler agent

Locations

Country	Name	City	State
Spain	Clinica Barem	Las Palmas de Gran Canaria	Las Palmas (Canary Islands)

Sponsors (2)

Lead Sponsor	Collaborator
Nektium Pharma SL	Clínica Barem

Country where clinical trial is conducted

Spain, 

References & Publications (17)

Balk E, Chung M, Chew P, Ip S, Raman G, Kupelnick B, Tatsioni A, Sun Y, Wolk B, DeVine D, Lau J. Effects of soy on health outcomes. Evid Rep Technol Assess (Summ). 2005 Aug;(126):1-8. Review. — View Citation

Bialonska D, Ramnani P, Kasimsetty SG, Muntha KR, Gibson GR, Ferreira D. The influence of pomegranate by-product and punicalagins on selected groups of human intestinal microbiota. Int J Food Microbiol. 2010 Jun 15;140(2-3):175-82. doi: 10.1016/j.ijfoodmi — View Citation

Buendía Bermejo J, Rodríguez Segarra R, Yubero Bascuñana N, Martínez Vizcaíno V. [Design and validation of a questionnaire in Spanish for measuring the quality of life in postmenopausal women: the MENCAV questionnaire]. Aten Primaria. 2001 Feb 15;27(2):94 — View Citation

Ferrari A. Soy extract phytoestrogens with high dose of isoflavones for menopausal symptoms. J Obstet Gynaecol Res. 2009 Dec;35(6):1083-90. doi: 10.1111/j.1447-0756.2009.01058.x. — View Citation

Greene JG. Constructing a standard climacteric scale. Maturitas. 1998 May 20;29(1):25-31. — View Citation

Heinemann K, Ruebig A, Potthoff P, Schneider HP, Strelow F, Heinemann LA, Do MT. The Menopause Rating Scale (MRS) scale: a methodological review. Health Qual Life Outcomes. 2004 Sep 2;2:45. — View Citation

Igwe SA, Emeruwa IC, Modie JA. Ocular toxicity of Afromomum melegueta (alligator pepper) on healthy Igbos of Nigeria. J Ethnopharmacol. 1999 Jun;65(3):203-6. — View Citation

Ilic NM, Dey M, Poulev AA, Logendra S, Kuhn PE, Raskin I. Anti-inflammatory activity of grains of paradise (Aframomum melegueta Schum) extract. J Agric Food Chem. 2014 Oct 29;62(43):10452-7. doi: 10.1021/jf5026086. Epub 2014 Oct 20. — View Citation

Kang SJ, Choi BR, Kim SH, Yi HY, Park HR, Kim DC, Choi SH, Han CH, Park SJ, Song CH, Ku SK, Lee YJ. Dried pomegranate potentiates anti-osteoporotic and anti-obesity activities of red clover dry extracts in ovariectomized rats. Nutrients. 2015 Apr 9;7(4):2 — View Citation

Klein MA, Nahin RL, Messina MJ, Rader JI, Thompson LU, Badger TM, Dwyer JT, Kim YS, Pontzer CH, Starke-Reed PE, Weaver CM. Guidance from an NIH workshop on designing, implementing, and reporting clinical studies of soy interventions. J Nutr. 2010 Jun;140( — View Citation

Low Dog T. Menopause: a review of botanical dietary supplements. Am J Med. 2005 Dec 19;118 Suppl 12B:98-108. Review. — View Citation

Mori-Okamoto J, Otawara-Hamamoto Y, Yamato H, Yoshimura H. Pomegranate extract improves a depressive state and bone properties in menopausal syndrome model ovariectomized mice. J Ethnopharmacol. 2004 May;92(1):93-101. — View Citation

Munro IC, Harwood M, Hlywka JJ, Stephen AM, Doull J, Flamm WG, Adlercreutz H. Soy isoflavones: a safety review. Nutr Rev. 2003 Jan;61(1):1-33. Review. — View Citation

Palacios S, Ferrer-Barriendos J, Parrilla JJ, Castelo-Branco C, Manubens M, Alberich X, Martí A; Grupo Cervantes. [Health-related quality of life in the Spanish women through and beyond menopause. Development and validation of the Cervantes Scale]. Med Cl — View Citation

Satpathy S, Patra A, Purohit AP. Estrogenic activity of Punica granatum L. peel extract. Asian Pacific J. Reprod. 2013; 2(1): 19-24

Sugita J, Yoneshiro T, Hatano T, Aita S, Ikemoto T, Uchiwa H, Iwanaga T, Kameya T, Kawai Y, Saito M. Grains of paradise (Aframomum melegueta) extract activates brown adipose tissue and increases whole-body energy expenditure in men. Br J Nutr. 2013 Aug;11 — View Citation

Tranche S, Brotons C, Pascual de la Pisa B, Macías R, Hevia E, Marzo-Castillejo M. Impact of a soy drink on climacteric symptoms: an open-label, crossover, randomized clinical trial. Gynecol Endocrinol. 2016 Jun;32(6):477-82. doi: 10.3109/09513590.2015.11 — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline to week 8 in the bogy weight	To evaluate the body weight reduccion, a variable to quantify the percentage of reduction between after-treatment and before-treatment in body weight (BW) is generated: [Variation%=100 x ((initial BW value-final BW value)/ initial BW value)]	8 weeks
Primary	Change from Baseline to Week 8 in the global score of quality of life using the validated Cervantes Scale	To evaluate the improvement of quality of life after trial, a variable to quantify the percentage of reduction between after-treatment and before-treatment for global score (GS) in quality of life is generated: [Variation%=100 x ((initial GS value-final GS value)/ initial GS value)]	8 weeks
Secondary	Change from Baseline to Week 8 in the Menopause-health score of quality of life using the validated Cervantes Scale	To evaluate the improvement of quality of life after trial, a variable to quantify the percentage of reduction between after-treatment and before-treatment for Menopause and health score (MHS) in quality of life is generated: [Variation%=100 x ((initial MHS value-final MHS value)/ initial MHS value)]	8 weeks
Secondary	Change from Baseline to Week 8 in the psychic score of quality of life using the validated Cervantes Scale	To evaluate the improvement of quality of life after trial, a variable to quantify the percentage of reduction between after-treatment and before-treatment for psychic score (PS) in quality of life is generated: [Variation%=100 x ((initial PS value-final PS value)/ initial PS value)]	8 weeks
Secondary	Change from Baseline to Week 8 in the sexuality-couple score of quality of life using the validated Cervantes Scale.	To evaluate the improvement of quality of life after trial, a variable to quantify the percentage of reduction between after-treatment and before-treatment for sexuality-couple score (SCS) in quality of life is generated: [Variation%=100 x ((initial SCS value-final SCS value)/ initial SCS value)]	8 weeks

External Links

•   Clinical guides for menopause from AEEM
•   paper on Validity and reliability of the Kupperman test [Spanish]