Sweet Thresholds in Healthy Volunteers Study

NCT ID: NCT06697847

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-27

Study Completion Date

2025-03-14

Brief Summary

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

Detailed Description

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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.

Conditions

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Taste Thresholds in Healthy Volunteers

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy volunteers

Adults with no mood disorder and who have not been diagnosed with or had treatment for a mood disorder in the last 6 months.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ranvier Health Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Westbury Lodge, Westbury Park

Bristol, City Of Bristol, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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David Adams S Chief Investigator, MBChB

Role: CONTACT

+44 759440372

Facility Contacts

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Michael Colgan

Role: primary

+44 7539 440372

Michaela M Willis, BA

Role: backup

+7539440372

Other Identifiers

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2Brsv1

Identifier Type: -

Identifier Source: org_study_id