Effect of Soya Bean on the Female Reproductive Hormones and Menopausal Symptoms

NCT07739615 | Not Yet Recruiting

• 1 other identifier: EBSHREC 04/040
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

Brief Summary

Menopause is one of the most emotionally, physically and Psychological miserable times in a woman's life.It occurs following cessation of menses resulting in the decline of endogenous estrogen. Phytoestrogens are natural plant derived compounds found in a wide variety of foods and soy bean is considered to be the richest source of plant estrogens. Current advances in management of menopause have relied on the use of hormone replacement therapy; however they are associated with adverse side effects if used over a long period of time. Currently, there is varying opinion regarding the physiological impact of soy bean consumption and results of studies are sparse and inconclusive. Hence, the need to determine the effect of soya bean consumption on the female reproductive hormones and relief of menopausal symptoms

Conditions

Menopausal Syndrome

Outcome Measures

Primary Outcomes (1)

• Changes in the Reproductive hormones

  Analysis of the Serum estrogen, progesterone, follicle stimulating hormone, lutenizing hormone and antimullerian hormone

  28days

Secondary Outcomes (1)

• Changes in menopausal symtoms

  28days

Study Arms (3)

50g Soya bean Group

EXPERIMENTAL

Received 50g daily of the soya bean powder as tea for 28days and their usual daily diet

Dietary Supplement: Soy Bean

100g Soya bean group

EXPERIMENTAL

Received 100g daily of the soya bean powder as tea for 28days and their usual daily diet

Dietary Supplement: Soy Bean

Normal Diet group

NO INTERVENTION

Was on their usual daily diet and acted as control for 28days.

Interventions

Soy Bean DIETARY_SUPPLEMENT

Soya bean is a phytoestrogen

100g Soya bean group; 50g Soya bean Group

Eligibility Criteria

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

You may qualify if:

• Women who gave consent
• Absence of Menses for more than 1year that is not due to medical treatment
• More than 40years of age

You may not qualify if:

• Women on hormone replacement therapy
• Women on any hormonal medication
• Allergy to soya products.
• year old or lesser

Sponsors & Collaborators

• Alex Ekwueme Federal University Teaching Hospital: lead

Study Officials

• DARLINTON-PETER CHIBUZOR UGOJI

  DAVID UMAHI FEDERAL UNIVERSITY TEACHING HOSPITAL UBURU, EBONYI STATE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DARLINTON-PETER CHIBUZOR UGOJI, FELLOWSHIP

CONTACT

08068748644; darlingtonpeter2012@gmail.com

Francis Iheanyichukwu Ugoji

CONTACT

08068748644; darlingtonpeter2012@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants and the outcome assessors were masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Model Details: 50g Soya bean Group: Received 50g daily of the soya bean powder as tea for 28days and their usual daily diet 100g Soya bean Group: Received 100g daily of the soya bean powder as tea for 28days and their usual daily diet Normal diet Group: Was on their usual daily diet and acted as control for 28days.

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 31, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1year
• Access Criteria: Those interested in it.