Clinical trial NCT04606524: Relationship Between MUC1 Expression and Gustatory Function in Postmenopausal Females
Official title: Relationship Between MUC1 Expression and Gustatory Function in Postmenopausal Females
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Taste, Altered
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: study will include 50 healthy females free from any systemic diseases or inder any medications that may affect gustatory function divided into 2 groups study group and it will include 25 postmenopausal females control group it will include 25 postmenopausal females

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Alterations of the gustatory function in postmenopausal females
timeFrame: 12-18 month
Secondary outcomes:
measure: MUC1 expression
timeFrame: 12-18 month
Other outcomes:
Locations:
Study officials:
affiliation: October 6 University
name: reham aggour
role: STUDY_DIRECTOR
References: