Sweet Thresholds in Healthy Volunteers Study

NCT06697847 | Recruiting

• 1 other identifier: 2Brsv1
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Taste Thresholds in Healthy Volunteers

Keywords

Taste thresholds; Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrolment to a final taste test 6 weeks later

Secondary Outcomes (3)

• Score on Becks Depression Inventory

  From enrolment to a final questionnaire 6 weeks later

• Score on Patient Health Questionnaire 9

  From enrolment to a final questionnaire 6 weeks later

• Score on Generalised Anxiety Disorder scale 7

  From enrolment to a final questionnaire 6 weeks later

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ranvier Health Ltd: lead

Study Sites (1)

Westbury Lodge, Westbury Park

Bristol, City Of Bristol, BS6 7JE, United Kingdom

RECRUITING

Central Study Contacts

David Adams S Chief Investigator, MBChB

CONTACT

+44 759440372; davidadams@ranvierhealth.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: November 27, 2024
• Primary Completion: January 31, 2025
• Study Completion: March 14, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)