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临床试验/NCT07739615
NCT07739615尚未招募不适用

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

Alex Ekwueme Federal University Teaching Hospital0 个研究点目标入组 69 人开始时间: 2026年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
69
主要终点
Changes in the Reproductive hormones

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

The participants and the outcome assessors were masked

入排标准

性别
Female
接受健康志愿者

入选标准

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

排除标准

  • Women on hormone replacement therapy
  • Women on any hormonal medication
  • Allergy to soya products.
  • 40year old or lesser

结局指标

主要结局

Changes in the Reproductive hormones

时间窗: 28days

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

次要结局

  • Changes in menopausal symtoms(28days)

研究者

发起方
Alex Ekwueme Federal University Teaching Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Darlington-Peter Chibuzor Ugoji

Medical doctor

Alex Ekwueme Federal University Teaching Hospital

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