Taste, AlteredNCT04606524
Relationship Between MUC1 Expression and Gustatory Function in Postmenopausal Females
An observational study of Taste, Altered, run by October 6 University.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Taste, Altered
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
Read the 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
- Conditions
- Taste, Altered
- Medical subject headings
- Dysgeusia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | 25 postmenopausal females will be included in this study | |
| control group | 25 premenopausal females will be included in this tudy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12-18 month
Secondary outcomes (1)
MUC1 expression
Two milliliters of Stimulated whole saliva from each participant will be collected and added to RNA stabilizing solution and used for RNA extraction
Measured: 12-18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study startOct 2020 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Taste, AlteredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Abdelwhab, October 6 University
- Investigators
- reham aggour, Study director, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606524
- Sponsor's protocol ID
- 8-2020
- Status last verified
- Oct 2020
- First submitted
- 29 Aug 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between MUC1 Expression and Gustatory Function in Postmenopausal Females
- ClinicalTrials.gov ID
- NCT04606524
- Acronym / sponsor ID
- 8-2020
- Conditions
- Taste, Altered
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | –25 postmenopausal females will be included in this study |
| control group | – | –25 premenopausal females will be included in this tudy |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Alterations of the gustatory function in postmenopausal females
Time frame: 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
1 secondary outcome
MUC1 expression
Time frame: 12-18 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Taste, Altered
Recruiting
Taste Alterations Study
Chemotherapy Side Effects, Taste, Altered
Not yet recruiting
Personalised Nutritional Care in Older Patients With Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer
Recruiting
Gustabor Phase 2 - Treating Taste Changes During Cancer Therapy: A Randomized Study Evaluating an AI- Based Nutrition Intervention
Multiple Myeloma (MM), GI Cancer
RecruitingObservational study
Changes in Taste and Eating Habits Associated With GLP-1 Agonists in Weight Loss Patients
Obesity & Overweight, Taste Alterations
Not yet recruitingObservational study
Adaptation Strategies for Coping With the Impact of Sensory Alterations on Eating Behavior in Children With Cancer: A Qualitative Study From the Perspective of Children and Parents
Taste Alterations, Smell Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
reham aggour study director
October 6 University
Questions about this trial
What is this clinical trial studying?
An observational study of Taste, Altered, run by October 6 University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact amira abdelwhab (01007647877 ext. 020, amira.abdelwhab.dent@o6u.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alterations of the gustatory function in postmenopausal females (time frame: 12-18 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.