NCT07066176

Brief Summary

Development of Intestinal Permeability Tests for Clinical Nutrition and Metabolic Health Studies

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

July 7, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

1 month

First QC Date

June 30, 2025

Last Update Submit

September 19, 2025

Conditions

Intestinal Permeability

Keywords

intestinal permeability

Outcome Measures

Primary Outcomes (1)

  • Intestinal permeability

    lactulose-to-mannitol ratio in urine

    From baseline to hour 5

Secondary Outcomes (1)

  • Intestinal permeability

    At baseline, hour 2, hour 3 and hour 4

Study Arms (3)

Water

NO INTERVENTION

Mannitol and lactulose diluted in water (500mL)

Mixed meal beverage

PLACEBO COMPARATOR

Mannitol and lactulose diluted in mixed meal beverage (500mL)

Dietary Supplement: Mixed meal beverage

Mixed meal beverage and aspirin

EXPERIMENTAL

Aspirin (650mg) prior to mannitol and lactulose diluted in mixed meal beverage (500mL)

Drug: AspirinDietary Supplement: Mixed meal beverage

Interventions

AspirinDRUG

Aspirin 650mg prior mixed meal beverage

Mixed meal beverage and aspirin
Mixed meal beverageDIETARY_SUPPLEMENT

Mixed meal beverage

Mixed meal beverageMixed meal beverage and aspirin

Eligibility Criteria

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

You may qualify if:

  • Men and women
  • BMI \<40

You may not qualify if:

  • Enteropathies
  • Food intolerance or allergy related to the protocol
  • Pregnancy or breastfeeding within the last 3 months
  • Contraindications for aspirin - see Monograph

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INAF

Québec, Quebec, G1Y3S8, Canada

Location

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Alain Veilleux, PhD

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 30, 2025

First Posted

July 15, 2025

Study Start

July 7, 2025

Primary Completion

August 15, 2025

Study Completion

August 15, 2025

Last Updated

September 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)