Relationship Between MUC1 Expression and Gustatory Function in Postmenopausal Females

NCT ID: NCT04606524

Last Updated: 2020-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-31

Study Completion Date

2021-12-31

Brief Summary

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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

Detailed Description

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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 (0.01-1.0 mM), citric acid (0.32-0.032 mol l-1), quinine hydrochloride (0.01- 1.0 mM) and sucrose (0.01-1.0 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 9:00 am and 11:00 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 10,000 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

Conditions

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Taste, Altered

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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study group

25 postmenopausal females will be included in this study

No interventions assigned to this group

control group

25 premenopausal females will be included in this tudy

No interventions assigned to this group

Eligibility Criteria

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Exclusion Criteria

* those who have any systemic diseases (such as diabetes, nutritional deficiency, cardiovascular, respiratory and endocrinal disorders).
* Also any history that could affect gustatory function (e.g medications \&radiotherapy or smoking
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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October 6 University

OTHER

Sponsor Role lead

Responsible Party

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Amira Abdelwhab

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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reham aggour

Role: STUDY_DIRECTOR

October 6 University

Central Contacts

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amira abdelwhab

Role: CONTACT

01007647877 ext. 020

Other Identifiers

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8-2020

Identifier Type: -

Identifier Source: org_study_id