Sweet Thresholds in Healthy Volunteers Study

Ranvier Health Ltd30 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Taste Thresholds in Healthy Volunteers

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Westbury Lodge, Westbury Park

Bristol, City Of Bristol, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

Sweet taste threshold

Sweet taste threshold established by applying varying concentrations of sucrose solution to the tongue and assessing whether a sweet taste can be detected by the participant. The sweet threshold is the minimum concentration at which a participant can reliably detect the sweet flavour.

Time frame: From enrolment to a final taste test 6 weeks later

Secondary Outcomes

Score on Becks Depression Inventory

Becks depression inventory will be completed by the participant at the first and last visit. The score will be calculated to check that the participant is free of mood disorder. The scale ranges from 1-40 and a score of less than 10 is normal. Higher scores suggest increasing degrees of depression.

Time frame: From enrolment to a final questionnaire 6 weeks later

Score on Patient Health Questionnaire 9

Patient Health Questionnaire 9 will be completed by the participant at the first and last visit. The score will be calculated to check that the participant is free of mood disorder. The scale ranges from 0-27 and a score less than 5 suggests the subject is not depressed.

Time frame: From enrolment to a final questionnaire 6 weeks later

Score on Generalised Anxiety Disorder scale 7

Generalised Anxiety Disorder scale 7 will be completed by the participant at the first and last visit. The score will be calculated to check that the participant is free of mood disorder. The scale ranges from 0-21. A score of less than 4 suggests minimal anxiety and increasing scores suggest greater anxiety symptoms.

Time frame: From enrolment to a final questionnaire 6 weeks later

Central Contacts

David Adams S Chief Investigator, MBChB

CONTACT

+44 759440372 davidadams@ranvierhealth.com

Data from ClinicalTrials.gov

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