Sweet Thresholds in Healthy Volunteers Study | NCT06697847

Studies
Sweet Thresholds in Healthy Volunteers Study

NCT06697847

Sponsor

Ranvier Health Ltd

Status

Completed

Last Update Posted

Jun 22, 2026Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Taste Thresholds in Healthy Volunteers

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 27, 2024Actual

Primary Completion Date

Jan 31, 2025Actual

Completion Date

Mar 14, 2025Actual

First Submitted Date

Nov 18, 2024

First Submission Date that Met QC Criteria

Nov 18, 2024

First Posted Date

Nov 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2026

Last Update Posted Date

Jun 22, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Label	Type	Description	Intervention Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.	From enrolment to a final questionnaire 6 weeks later

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults without mood questionnaires recruited by word of mouth and posters in retail establishments in England and Wales

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Westbury Lodge, Westbury Park		Bristol	City Of Bristol	BS6 7JE	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Data collected contains sensitive information and even when anonymised contains commercially sensitive information

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided