Skip to content

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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07739615
Enrollment
69
Registered
2026-07-31
Start date
2026-08-01
Completion date
2026-08-30
Last updated
2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopausal Syndrome

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

Detailed description

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. Sixty nine postmenopausal women will be randomized into three groups of 23 each. Group 1received 50g daily of the soya bean powder as tea for 28days, Group 2 received 100g daily of the soya bean powder as tea for 28days and Group 3 was on their normal diet and acts as control for 28days. Questionnaire and blood samples will be collected before and after the 28days for analysis. Blood will be assayed for the female reproductive hormone(Estrogen, Progesterone, Antimullerin hormone, FSH and LH), while standardized questionnaire will be used to get information on about objective of the study. The generated data will be analyzed with International Business Machine Statistical Package for Social Science (IBM-SPSS) software version 22(Chicago II, USA) 2015. Students' t-test (t-test) will be used for comparison between groups for continuous variables while chi-square (χ2) test will be used for categorical variables. Values were expressed as mean ± SD. Statistical significance will be considered at P\<0.05.

Interventions

DIETARY_SUPPLEMENTSoy Bean

Soya bean is a phytoestrogen

Sponsors

Alex Ekwueme Federal University Teaching Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The participants and the outcome assessors were masked

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

1. Women who gave consent 2. Absence of Menses for more than 1year that is not due to medical treatment 3. More than 40years of age

Exclusion criteria

1. Women on hormone replacement therapy 2. Women on any hormonal medication 3. Allergy to soya products. 4. 40year old or lesser

Design outcomes

Primary

MeasureTime frameDescription
Changes in the Reproductive hormones28daysAnalysis of the Serum estrogen, progesterone, follicle stimulating hormone, lutenizing hormone and antimullerian hormone

Secondary

MeasureTime frameDescription
Changes in menopausal symtoms28daysUsing questionaire and standardised tools to collect information about menopausal symtoms

Contacts

CONTACTDARLINTON-PETER CHIBUZOR UGOJI, FELLOWSHIP
darlingtonpeter2012@gmail.com08068748644
CONTACTFrancis Iheanyichukwu Ugoji
darlingtonpeter2012@gmail.com08068748644
PRINCIPAL_INVESTIGATORDARLINTON-PETER CHIBUZOR UGOJI

DAVID UMAHI FEDERAL UNIVERSITY TEACHING HOSPITAL UBURU, EBONYI STATE

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026