Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04606524
Status:
UNKNOWN
Last Update Posted:
2020-10-28
First Post:
2020-08-29
Brief Title:
Relationship Between MUC1 Expression and Gustatory Function in Postmenopausal Females
Sponsor:
October 6 University
Organization:
October 6 University
Study Overview
Official Title:
Relationship Between MUC1 Expression and Gustatory Function in Postmenopausal Females
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
50 females will be included in this study they will be divided into 2 groups study group which will include 25 postmenopausal females - and control group which will include premenopausal females For testing gustatory function a whole mouth above threshold taste test will be carried out in which a concentration of sucrose sodium chloride citric acid and quinine hydrochloride solutions were used for sweet salty sour and bitter types of taste respectively
Saliva will be collected to evaluate MUC1 expression
Saliva will be collected to evaluate MUC1 expression
Detailed Description:
50 females will be included in this study they will be divided into 2 groups study group which will include 25 postmenopausal females - and control group which will include premenopausal females
For testing gustatory function a whole mouth above threshold taste test will be carried out in which a concentration of sucrose sodium chloride citric acid and quinine hydrochloride solutions were used for sweet salty sour and bitter types of taste respectively Five concentration levels in ½ log steps of sodium chloride 001-10 mM citric acid 032-0032 mol l-1 quinine hydrochloride 001- 10 mM and sucrose 001-10 mM will be prepared in 5 ml samples All the solutions will be made with distilled water The intensity threshold of taste perception of each solution will be determined by scoring the lowest concentration as 5 and the highest concentration as 1 The solutions will be given in increasing concentrations The patient then should identify the quality salty sour sweet bitter or tasteless and intensity of each test solution Quality judgments for each solution will be coded as correct incorrect or tasteless by asking subjects to name the taste they perceived
Saliva will be collected in the morning between 900 am and 1100 am Patient will be instructed to stop eating and drinking at least 2 h before sample collection Chewing 1 g of gum base will be used to stimulate salivary flow The saliva that will be collected for the first 2 min will be discarded and then Stimulated whole saliva will be collected for the next 10 min with the mechanical chewing stimulation
Two milliliters of Stimulated whole saliva from each participant will be collected and added to RNA stabilizing solution and used for RNA extraction The SWS samples will be centrifuged at 10000 g for 20 min at 48C to remove any cellular debris The clarified supernatants will be aliquoted and frozen at 70 C for analytic experiments
this is to determination of oral mucosal epithelial MUC1 expression level
For testing gustatory function a whole mouth above threshold taste test will be carried out in which a concentration of sucrose sodium chloride citric acid and quinine hydrochloride solutions were used for sweet salty sour and bitter types of taste respectively Five concentration levels in ½ log steps of sodium chloride 001-10 mM citric acid 032-0032 mol l-1 quinine hydrochloride 001- 10 mM and sucrose 001-10 mM will be prepared in 5 ml samples All the solutions will be made with distilled water The intensity threshold of taste perception of each solution will be determined by scoring the lowest concentration as 5 and the highest concentration as 1 The solutions will be given in increasing concentrations The patient then should identify the quality salty sour sweet bitter or tasteless and intensity of each test solution Quality judgments for each solution will be coded as correct incorrect or tasteless by asking subjects to name the taste they perceived
Saliva will be collected in the morning between 900 am and 1100 am Patient will be instructed to stop eating and drinking at least 2 h before sample collection Chewing 1 g of gum base will be used to stimulate salivary flow The saliva that will be collected for the first 2 min will be discarded and then Stimulated whole saliva will be collected for the next 10 min with the mechanical chewing stimulation
Two milliliters of Stimulated whole saliva from each participant will be collected and added to RNA stabilizing solution and used for RNA extraction The SWS samples will be centrifuged at 10000 g for 20 min at 48C to remove any cellular debris The clarified supernatants will be aliquoted and frozen at 70 C for analytic experiments
this is to determination of oral mucosal epithelial MUC1 expression level
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None