NCT07172009

Brief Summary

The digestion of carbohydrates begins in the mouth through the salivary enzyme amylase which breaks food starches into maltose and disaccharides. The mouth also has a large community of microorganisms which include bacteria, fungi, viruses and protozoa that can also assist in the digestion of carbohydrates. Mouthwashes containing antibacterial compounds such as chlorhexidine are used to kill oral bacteria, but current evidence indicates that a majority of these bacteria are essential for human health. The aim of this study is to investigate whether chlorhexidine mouthwash can also affect the digestion of carbohydrates. At least 25 individuals will be recruited. Participants will visit the laboratory in two occasions. A saliva and blood sample (fingertip to measure blood glucose) will be taken at baseline. Then, using a randomized, cross-over and double-blind design, the participants will rinse their mouth for two minutes with a placebo or chlorhexidine mouthwash. Then, participants will eat 50 g of white bread and blood glucose will be measured (fingertips) every 30 min for the following 2 hours. Another saliva sample will be collected at the end of each test.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress98%
Jun 2022Jun 2026

Study Start

First participant enrolled

June 8, 2022

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

3.5 years

First QC Date

September 11, 2025

Last Update Submit

September 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood glucose

    2 hours

Study Arms (2)

Chlorhexidine

EXPERIMENTAL
Other: Chlorhexidine mouthwash

Placebo

PLACEBO COMPARATOR
Other: Placebo mouthwash

Interventions

Rinsing the mouth with chlorhexidine mouthwash for 2 minutes before consuming 50 g of carbohydrates

Chlorhexidine

Rinsing the mouth with placebo mouthwash for 2 minutes before consuming 50 g of carbohydrates

Placebo

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Plymouth

Plymouth, Devon, PL4 8AA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Glucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Raul Bescos Garcia

    University of Plymouth

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Human Nutrition & Physiology

Study Record Dates

First Submitted

September 11, 2025

First Posted

September 15, 2025

Study Start

June 8, 2022

Primary Completion

December 10, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations