NCT04606524

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

August 29, 2020

Last Update Submit

October 22, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Alterations of the gustatory function in postmenopausal females

    , 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

    12-18 month

Secondary Outcomes (1)

  • MUC1 expression

    12-18 month

Study Arms (2)

study group

25 postmenopausal females will be included in this study

control group

25 premenopausal females will be included in this tudy

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Analysis of epithelial oral mucosal MUC1 expression level in saliva

MeSH Terms

Conditions

Dysgeusia

Condition Hierarchy (Ancestors)

Taste DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • reham aggour

    October 6 University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 29, 2020

First Posted

October 28, 2020

Study Start

October 1, 2020

Primary Completion

October 1, 2021

Study Completion

December 1, 2021

Last Updated

October 28, 2020

Record last verified: 2020-10