Relationship Between MUC1 Expression and Gustatory Function in Postmenopausal Females

Sponsor
October 6 University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04606524
Collaborator
(none)
50
14

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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 (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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Relationship Between MUC1 Expression and Gustatory Function in Postmenopausal Females
    Anticipated Study Start Date :
    Oct 1, 2020
    Anticipated Primary Completion Date :
    Oct 1, 2021
    Anticipated Study Completion Date :
    Dec 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    study group

    25 postmenopausal females will be included in this study

    control group

    25 premenopausal females will be included in this tudy

    Outcome Measures

    Primary Outcome Measures

    1. Alterations of the gustatory function in postmenopausal females [12-18 month]

      , 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

    Secondary Outcome Measures

    1. MUC1 expression [12-18 month]

      Two milliliters of Stimulated whole saliva from each participant will be collected and added to RNA stabilizing solution and used for RNA extraction

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Inclusion criteria for study group include individuals who are in the age range of 50-75 years, history of complete amenorrhoea patients who are not taking any medication [including hormone replacement therapy (HRT) for female patients]. Also females who are not a denture wearer and those who are having good oral hygiene.

    Inclusion criteria for study group include individuals who are in the range between 20-40 years with normal menstrual cycle of 28 to 30 days. they should be healthy volunteers free from any systemic diseases

    Exclusion Criteria:
    • Exclusion criteria for both groups include patients having any oral diseases (like oral candidiasis)

    • 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • October 6 University

    Investigators

    • Study Director: reham aggour, October 6 University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amira Abdelwhab, Dr., October 6 University
    ClinicalTrials.gov Identifier:
    NCT04606524
    Other Study ID Numbers:
    • 8-2020
    First Posted:
    Oct 28, 2020
    Last Update Posted:
    Oct 28, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 28, 2020