NCT07362563

Brief Summary

The main objective of this study is to evaluate the acute effects of prebiotic sodas on postprandial levels of glucagon-like peptide-1 (GLP-1), peptide YY (PYY), gastric emptying, and satiety levels in healthy adults.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 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 Start

First participant enrolled

January 1, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

January 9, 2026

Last Update Submit

January 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood GLP-1 iAUC

    Incremental area under the curve (iAUC) for GLP-1 from immediately prior to test-product consumption (t=0) to t=120 min following test-product consumption.

    For 2 hours post intervention

Secondary Outcomes (3)

  • Blood PYY iAUC

    For 2 hours post intervention

  • Gastric Emptying Rate/Transit Time via Acetaminophen

    Oral dose of acetaminophen with blood samples taken for 2 hours post intervention

  • Change in Perceived Satiety Levels

    For 2 hours post intervention

Study Arms (4)

Control Soda

PLACEBO COMPARATOR

Participants will consume one 12 oz can of a control soda

Other: Control Soda

Prebiotic Soda - Shelf Stable

EXPERIMENTAL

Participants will consume one 12 oz can of the shelf stable prebiotic soda

Other: Prebiotic Soda - Shelf Stable

Prebiotic Soda - Refrigerated

EXPERIMENTAL

Participants will consume one 12 oz can of the refrigerated prebiotic soda

Other: Prebiotic Soda - Refrigerated

Prebiotic Soda - Shelf Stable + Functional Ingredient

EXPERIMENTAL

Participants will consume one 12 oz can of the shelf stable prebiotic soda with an added functional ingredient

Other: Prebiotic Soda - Shelf Stable + Functional Ingredient

Interventions

Participants will consume one 12 oz can of a control soda that contains 0 g dietary fiber and 4 g total sugar.

Control Soda

Participants will consume one 12 oz can of a shelf stable prebiotic soda that contains 6 g dietary fiber and 4 g total sugar.

Prebiotic Soda - Shelf Stable

Participants will consume one 12 oz can of a shelf stable prebiotic soda that contains 9 g dietary fiber and 4 g total sugar.

Prebiotic Soda - Refrigerated

Participants will consume one 12 oz can of a shelf stable prebiotic soda that contains 6 g dietary fiber, 4 g total sugar, and an added functional ingredient.

Prebiotic Soda - Shelf Stable + Functional Ingredient

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 18-60 years, inclusive.
  • BMI between 18.0 and 30.0 kg/m2.
  • Stable weight in the last 3 months (+/-5kg).
  • Willing to abstain from unusual strenuous exercise, consuming alcoholic drinks and from taking fiber supplements for 24 hours before study days.
  • Willing to refrain from smoking tobacco or e-cigarettes, and using marijuana in any form for 12h before and during study visits.
  • Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
  • Subjects must be eligible to receive income in Canada and be covered by a health insurance plan such as Ontario Health Insurance Plan (OHIP).

You may not qualify if:

  • Self-reported pregnant or breastfeeding women.
  • Subjects with a history of severe food allergies or an allergy to acetaminophen.
  • Known history of diabetes, any gastrointestinal disorder that alters the absorption of nutrients, liver disease, or the presence of any health condition, illness or drug use that increases risk to the subject or to others or may affect the results, as judged by the Qualified Investigator (QI).
  • Subjects who are currently or in the last 2 months have been on oral or injectable GLP-1 receptor agonist (RA) medications.
  • Subjects who consume more than 14 alcoholic drinks per week, or more than 5 alcoholic drinks on any one occasion.
  • Subjects who have been on antibiotic therapy in the last 2 months.
  • Subjects taking the blood thinning drug warfarin.
  • Subjects who are habitual users of the following supplements in the past 30 days: berberine, curcumin, cinnamon, resveratrol, and gardenia.
  • Subjects which have undergone major surgery in the last 3 months.
  • Unwillingness or inability to comply with experimental procedures and to follow Inquis safety guidelines.
  • Subject is currently participating or recently (within 30 days of screening) participated in a clinical trial involving long-term exposure (greater than 24 hours) to an investigational drug, nutritional supplement, or lifestyle modification.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inquis Clinical Research

Toronto, Ontario, M5C 2N8, Canada

RECRUITING

MeSH Terms

Interventions

sodium bicarbonate-based toothpaste

Study Officials

  • Janice Campbell

    INQUIS Clinical Research

    STUDY DIRECTOR

Central Study Contacts

Director of Clinical Operations

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2026

First Posted

January 23, 2026

Study Start

January 1, 2026

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations