- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07739615
Effect of Soya Bean on the Female Reproductive Hormones and Menopausal Symptoms
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: DARLINTON-PETER CHIBUZOR UGOJI, FELLOWSHIP
- Telefonnummer: 08068748644
- E-post: darlingtonpeter2012@gmail.com
Studera Kontakt Backup
- Namn: Francis Iheanyichukwu Ugoji
- Telefonnummer: 08068748644
- E-post: darlingtonpeter2012@gmail.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Women who gave consent
- Absence of Menses for more than 1year that is not due to medical treatment
- More than 40years of age
Exclusion Criteria:
- Women on hormone replacement therapy
- Women on any hormonal medication
- Allergy to soya products.
- 40year old or lesser
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 50g Soya bean Group
Received 50g daily of the soya bean powder as tea for 28days and their usual daily diet
|
Soya bean is a phytoestrogen
|
|
Experimentell: 100g Soya bean group
Received 100g daily of the soya bean powder as tea for 28days and their usual daily diet
|
Soya bean is a phytoestrogen
|
|
Inget ingripande: Normal Diet group
Was on their usual daily diet and acted as control for 28days.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in the Reproductive hormones
Tidsram: 28days
|
Analysis of the Serum estrogen, progesterone, follicle stimulating hormone, lutenizing hormone and antimullerian hormone
|
28days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in menopausal symtoms
Tidsram: 28days
|
Using questionaire and standardised tools to collect information about menopausal symtoms
|
28days
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: DARLINTON-PETER CHIBUZOR UGOJI, DAVID UMAHI FEDERAL UNIVERSITY TEACHING HOSPITAL UBURU, EBONYI STATE
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- EBSHREC 04/040
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Tidsram för IPD-delning
Kriterier för IPD Sharing Access
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- ANALYTIC_CODE
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
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