Sweet Thresholds in Healthy Volunteers Study

November 25, 2024 updated by: Ranvier Health Ltd

Assessing Taste Thresholds and Scores on Standardised Mood Questionnaires in Participants Without Mood Disorders

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

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sweet taste threshold
Time Frame: From enrolment to a final taste test 6 weeks later
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score on Becks Depression Inventory
Time Frame: From enrolment to a final questionnaire 6 weeks later
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
Score on Patient Health Questionnaire 9
Time Frame: From enrolment to a final questionnaire 6 weeks later
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.
From enrolment to a final questionnaire 6 weeks later
Score on Generalised Anxiety Disorder scale 7
Time Frame: From enrolment to a final questionnaire 6 weeks later
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.
From enrolment to a final questionnaire 6 weeks later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ranvier Health Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 27, 2024

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

March 14, 2025

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

November 18, 2024

First Posted (Actual)

November 20, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2Brsv1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Taste Thresholds in Healthy Volunteers

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe