Is the artificial sweetener, sucralose, linked to gastrointestinal disruption during exercise?

ISRCTN	ISRCTN94557091
DOI	https://doi.org/10.1186/ISRCTN94557091
Sponsor	Central Michigan University
Funder	Central Michigan University

Submission date: 10/08/2026
Registration date: 10/08/2026
Last edited: 10/08/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Micah Zuhl
Principal investigator, Public, Scientific

Central Michigan University
1280 E CAMPUS DR College of Health Prof room 2219
Mount Pleasant
48859
United States of America

Phone	+1 (0)9897747762
Email	zuhl1m@cmich.edu

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Placebo
Assignment	Sequential
Purpose	Basic science
Scientific title	The impact of oral sucralose ingestion during exercise on markers of gastrointestinal discomfort and damage among healthy adults
Study objectives	The purpose of this study is to examine the effects of oral ingestion of sucralose during exercise on markers of gastrointestinal discomfort and damage.
Ethics approval(s)	Approved 27/01/2017, Central Michigan University Institutional Review Board 1 (Foust 104, Mount Pleasant, 48859, United States of America; +1 (0)9897746401; irb@cmich.edu), ref: 988458-2
Health condition(s) or problem(s) studied	Physically active adults with no known cardiopulmonary, metabolic, or immune disorders
Intervention	Ten healthy volunteers (aged 19-30 years) who exercise regularly will be recruited into a randomized controlled trial with a crossover design. Randomization will be sequential. The initial visit will be to answer a health history questionnaire, and perform baseline testing (body composition testing and a maximal exercise test). Additional visits will consist of ingesting a small dose of sucralose (44 mg) or a water placebo at rest, and during exercise. The exercise will be a 60-minute treadmill run/walk at 70% intensity. Venous blood (10 ml, 0.675 tbsp) will be collected during each visit to the lab to measure plasma markers of gastrointestinal distress.
Intervention type	Supplement
Primary outcome measure(s)	Gastrointestinal barrier integrity: intestinal fatty acid binding protein (I-FABP) levels in plasma measured using an enzyme-linked immunosorbent assay (ELISA) at baseline (pre) and immediately after exercise Gastrointestinal damage: claudin-3 (CLDN-3) levels in plasma measured using an enzyme-linked immunosorbent assay (ELISA) at baseline (pre) and immediately after exercise Gastrointestinal discomfort measured using a 1-5 point Likert scale at baseline (pre) and immediately post exercise Gastrointestinal symptoms measured using a 0-9 point scale at the post-exercise timepoint only
Key secondary outcome measure(s)
Completion date	01/05/2017

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	19 Years
Upper age limit	30 Years
Sex	All
Target sample size at registration	10
Total final enrolment	10
Key inclusion criteria	Physically active runners - running more than 60 minutes continuously each week
Key exclusion criteria	1. Known gastrointestinal, liver, seizure, or kidney disorder 2. Taking certain medications (nonsteroidal anti-inflammatory drugs [NSAIDs], antidepressants, or diuretics); nutritional supplements, including proteins, creatine, amino acids (e.g., branched-chain amino acids [BCAAs], glutamine, taurine), antioxidants (e.g., turmeric, curcumin, sulforaphane, omega-3), and prebiotics and probiotics
Date of first enrolment	01/02/2017
Date of final enrolment	01/04/2017

Locations

Countries of recruitment

United States of America

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

10/08/2026: Study's existence confirmed by Central Michigan University Institutional Review Board 1.