Clinical trial NCT06697847: Sweet Thresholds in Healthy Volunteers Study
Official title: Assessing Taste Thresholds and Scores on Standardised Mood Questionnaires in Participants Without Mood Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Taste Thresholds in Healthy Volunteers
Keywords: Taste thresholds
Healthy volunteers
Lead sponsor: Ranvier Health Ltd
Sponsor class: INDUSTRY
First posted: 2024-11-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults without mood questionnaires recruited by word of mouth and posters in retail establishments in England and Wales

Brief summary: The sweet threshold (concentration of sucrose in water) at which healthy participants can detect a sweet flavour will be recorded.

Detailed description: The sweet threshold (concentration of sucrose in water) at which healthy participants can detect a sweet flavour will be recorded by means of application on a cotton bud to the anterior third of the tongue. Solutions will be presented in a pseudo-randomised order. Mood questionnaires will be completed (to check that participants are indeed healthy). The questionnaires used will be the Patient Health Questionnaire 9 (PHQ9), Beck's Depression Inventory (BDI) and Generalised Anxiety Disorder Questionnaire 7 (GAD-7).

This data is being collected with the intention of its use for comparison with sweet thresholds established in other populations using the same method of sweet threshold estimation.

Eligibility criteria: Inclusion Criteria:

. Male and female adults of 18 years old and over;

* Participants without a diagnosis of major depressive disorder (MDD) / anxiety disorder;
* Participants not taking an antidepressant during the preceding 6 months
* Not suffering from significant other mental or physical illness, such as confirmed psychosis, end of life care, or any other condition assessed as significant by the Site Investigator;
* Willing and able to comply with all study-related procedures;
* Not having COVID 19 or continuing effects of COVID 19 including altered sense of taste;
* Understands the study requirements and the treatment procedures and is able to provide written informed consent.

Exclusion Criteria:

* Taking antidepressant medication currently or during the previous 6 months;
* Known or suspected hypersensitivity or intolerance to any taste testing solutions, or any of their excipients;
* A history or presence of neurological or confounding psychiatric conditions (such as stroke, traumatic brain injury, epilepsy, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack, or schizophrenia);
* Patients with a diagnosis of chronic pain;
* Pregnancy or possibility pregnancy, or breastfeeding;
* Participants using supplements containing psychoactive herbs (for example St Johns Wort or 5-HTP (5-Hydroxytryptophan, also known as oxitriptan);
* Participants regularly using psychoactive stimulants (for example MDMA);
* Participants unable or unwilling to comply with study procedures.

Primary outcomes:
measure: Sweet taste threshold
timeFrame: From enrolment to a final taste test 6 weeks later
Secondary outcomes:
measure: Score on Becks Depression Inventory
timeFrame: From enrolment to a final questionnaire 6 weeks later
measure: Score on Patient Health Questionnaire 9
timeFrame: From enrolment to a final questionnaire 6 weeks later
measure: Score on Generalised Anxiety Disorder scale 7
timeFrame: From enrolment to a final questionnaire 6 weeks later
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Westbury Lodge, Westbury Park
state: City Of Bristol
Study officials:
References: