NCT06291337

Brief Summary

The sweet taste receptor, TAS1R2-TAS1R3, is expressed both orally, where it signals sweet taste, and extraorally in the intestine and pancreas, where it may affect glucose absorption and metabolism. Recently, ibuprofen and naproxen have been identified to inhibit human T1R3 when heterologously expressed in cells. In the present study, the initial objective was to determine if ibuprofen and naproxen inhibit interactions of sugars with human sweet taste receptor under normal, physiological conditions. Ten healthy participants were asked to rate sweetness intensity for a range of sweet stimuli (sucrose, fructose, sucralose) after a prerinse of ibuprofen, naproxen or water. Both ibuprofen and naproxen inhibited sweet taste intensity in a dose-dependent manner. In association studies, ibuprofen use has been linked to preserved metabolic function, as its use is correlated with lower rates of Alzheimer's disease, diabetes and colon cancer. Here the investigators present a potential novel pathway for systemic ibuprofen to impact these metabolic diseases.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
Last Updated

March 4, 2024

Status Verified

February 1, 2024

Enrollment Period

3.3 years

First QC Date

February 15, 2024

Last Update Submit

February 26, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Sweet taste ratings

    The impact of oral rinses with NSAIDS on sweet taste ratings of sugars on a labeled magnitude scale was assessed. The numeric outcome is the value of sweetness intensity provided by the participant from the labeled magnitude scale with each sweetener oral rinse.

    6 months

  • Sugar detection thresholds

    The impact of oral rinses with NSAIDS on detection thresholds for sugars was assessed. The detection threshold is the lowest concentration of the sweetener solution that can be distinguished from water. The numeric outcome is the concentration of sweetener solution that can be distinguished from water.

    6 months

Study Arms (2)

Treatment of sweet taste receptors with Ibuprofen oral rinse

EXPERIMENTAL

Participants were tested for sweetness perception without and with an oral rinse of ibuprofen.

Drug: Inhibition of Sweet Taste by Ibuprofen Oral Rinses

Treatment of sweet taste receptors with naproxen oral rinse

EXPERIMENTAL

Participants were tested for sweetness perception without and with an oral rinse of naproxen.

Drug: Inhibition of Sweet Taste by Naproxen Oral Rinses

Interventions

Participants rinse the mouth with ibuprofen and the impact on perceived sweet taste elicited by sugar solutions in the mouth was assessed

Treatment of sweet taste receptors with Ibuprofen oral rinse

Participants rinse the mouth with naproxen and the impact on perceived sweet taste elicited by sugar solutions in the mouth was assessed

Treatment of sweet taste receptors with naproxen oral rinse

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant must be able to taste sugars as sweet
  • Participant must be able to make ratings on a scale and follow instructions

You may not qualify if:

  • Participant must not be on any medications that would preclude exposure to NSAIDS
  • Participant must not be on any medications that are know to alter taste perception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Food Science and Nutritional Sciences

New Brunswick, New Jersey, 08901, United States

Location

Study Officials

  • Paul A Breslin, Ph.D.

    Rutgers University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: We are testing individual sin a within subject control for their sweet taste ratings of sugars without and with oral rinses of ibuprofen and naproxen.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 15, 2024

First Posted

March 4, 2024

Study Start

June 1, 2020

Primary Completion

September 1, 2023

Study Completion

September 30, 2023

Last Updated

March 4, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial, after de-identification.

Shared Documents
STUDY PROTOCOL
Time Frame
Immediately following publication and ending 7 years following article publication.
Access Criteria
Researchers who provide a methodologically sound proposal. Proposals should be directed to breslin@monell.org to request data to achieve aims of the proposal. Data are available for 7 years at a third party website:
More information

Locations