NCT04381026

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2020

Completed
Last Updated

May 8, 2020

Status Verified

May 1, 2020

Enrollment Period

1.1 years

First QC Date

May 5, 2020

Last Update Submit

May 5, 2020

Conditions

MenopauseDietary SupplementsQuality of Life

Keywords

MenopauseHot flushesIsoflavonesAframomum melegueta extractPunica granatum extractCervantes Scale

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change from Baseline to Week 8 in the Menopause-health score of quality of life using the validated Cervantes Scale

    8 weeks

  • Change from Baseline to Week 8 in the psychic score of quality of life using the validated Cervantes Scale

    8 weeks

  • Change from Baseline to Week 8 in the sexuality-couple score of quality of life using the validated Cervantes Scale.

    8 weeks

Other Outcomes (1)

  • Change from baseline to week 8 in the bogy weight

    8 weeks

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

Pill of 500 mg containing filler agent, two pills daily for eight weeks.

Dietary Supplement: Placebo

Treatment Group with botanical extracts

EXPERIMENTAL

Pill of 500 mg containing botanicals and filler agent, two pills daily for eight weeks.

Dietary Supplement: Botanical dry extracts combination

Interventions

Botanical dry extracts combinationDIETARY_SUPPLEMENT

Aframomum melgueta dry extract (50mg), Glycine max bean dry extract (100mg) and Punica granatum skin extract (100mg)

Treatment Group with botanical extracts
PlaceboDIETARY_SUPPLEMENT

Filler agent

Placebo Group

Eligibility Criteria

Age45 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women in the Climacteric Phase under medical criteria based on Health questionnaire, Blood and urine test.
  • Informed consent to participate in the study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Barem

Las Palmas de Gran Canaria, Las Palmas (Canary Islands), 35005, Spain

Location

Related Publications (18)

  • Greene JG. Constructing a standard climacteric scale. Maturitas. 1998 May 20;29(1):25-31. doi: 10.1016/s0378-5122(98)00025-5.

    PMID: 9643514RESULT

  • Buendia Bermejo J, Rodriguez Segarra R, Yubero Bascunana N, Martinez Vizcaino 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):94-100. doi: 10.1016/s0212-6567(01)78780-x. Spanish.

    PMID: 11256098RESULT

  • Palacios S, Ferrer-Barriendos J, Parrilla JJ, Castelo-Branco C, Manubens M, Alberich X, Marti A; Grupo Cervantes. [Health-related quality of life in the Spanish women through and beyond menopause. Development and validation of the Cervantes Scale]. Med Clin (Barc). 2004 Feb 21;122(6):205-11. doi: 10.1016/s0025-7753(04)74198-6. Spanish.

    PMID: 15012887RESULT

  • 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. doi: 10.1186/1477-7525-2-45.

    PMID: 15345062RESULT

  • Low Dog T. Menopause: a review of botanical dietary supplements. Am J Med. 2005 Dec 19;118 Suppl 12B:98-108. doi: 10.1016/j.amjmed.2005.09.044.

    PMID: 16414334RESULT

  • Tranche S, Brotons C, Pascual de la Pisa B, Macias 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: 10.3109/09513590.2015.1132305. Epub 2016 Jan 25.

    PMID: 26806546RESULT

  • 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):2622-47. doi: 10.3390/nu7042622.

    PMID: 25912038RESULT

  • 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. doi: 10.1037/e439502005-001. No abstract available.

    PMID: 16194125RESULT

  • 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.

    PMID: 20025635RESULT

  • 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(6):1192S-1204S. doi: 10.3945/jn.110.121830. Epub 2010 Apr 14.

    PMID: 20392880RESULT

  • 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. doi: 10.1301/nr.2003.janr.1-33.

    PMID: 12638461RESULT

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

    RESULT

  • 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.ijfoodmicro.2010.03.038. Epub 2010 Apr 2.

    PMID: 20452076RESULT

  • 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. doi: 10.1016/j.jep.2004.02.006.

    PMID: 15099854RESULT

  • 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.

    PMID: 25293633RESULT

  • 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;110(4):733-8. doi: 10.1017/S0007114512005715. Epub 2013 Jan 11.

    PMID: 23308394RESULT

  • 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. doi: 10.1016/s0378-8741(98)00188-3.

    PMID: 10404417RESULT

  • Lopez-Rios L, Barber MA, Wiebe J, Machin RP, Vega-Morales T, Chirino R. Influence of a new botanical combination on quality of life in menopausal Spanish women: Results of a randomized, placebo-controlled pilot study. PLoS One. 2021 Jul 21;16(7):e0255015. doi: 10.1371/journal.pone.0255015. eCollection 2021.

    PMID: 34288973DERIVED

Related Links

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Laura López-Ríos, PhD

    Nektium Pharma SL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 8, 2020

Study Start

April 19, 2017

Primary Completion

June 6, 2018

Study Completion

July 10, 2018

Last Updated

May 8, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)