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Chocolate study: do sugar substitutes cause stomach issues?

NCT ID NCT06479330

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how different amounts of a sugar replacer blend in chocolate affect stomach comfort in healthy adults. 60 people took part in a blinded, crossover trial where they ate chocolate with varying doses of the replacer. Researchers measured symptoms like bloating, gas, and nausea to see how well the ingredients were tolerated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Jul 2024

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Non-pregnant, non-lactating, healthy individuals aged 18-55 years, inclusive * Body Mass Index (BMI) 18.5-32.0kg/m², inclusive * No major illness, trauma or surgery requiring hospitalization within 3 months of the screening visit * Ability to understand the study procedures and willing to provide informed consent to participate in the study * Non-smokers or smokers who smoke \<10 cigarettes/day and are willing not to change nicotine habits during the study period * Willing to limit alcohol consumption to ≤3 standard drinks/day and ≤7 standard drinks/week during the study period * Willing to refrain from any marijuana or hemp products during the study period * Normal bowel habits (\>2 bowel movements/week and \<3 bowel movements per day) * Consumes ≤4 servings/day of fruits and vegetables combined and ≤3 (women) or ≤4 (men) servings/day of whole grains using the definitions of "serving" . * Participants must have a cell phone/tablet/computer and be willing and able to use it to collect study data * Participants must be eligible to receive income in Canada and be covered by a health insurance plan such as OHIP (Ontario Health Insurance Plan) * Participants are willing to follow current COVID guidelines with respect to attending study visits Exclusion Criteria: * Failure to meet any one of the inclusion criteria * Chronic moderate to severe gastrointestinal symptoms * Use of systemic antibiotics, antifungals or antiparasitics in the past 3 months and during the experimental period * Use of medications, supplements, and products which may affect the results (laxative, anti-diarrhea, anti-constipation drugs, high fiber supplements) * Individuals with any medical conditions or use of supplements or medications that increase risk to the subject or others or may affect the results, as judged by the Principal - Investigator * Unwillingness or inability to comply with the experimental procedures and to follow INQUIS safety guidelines * Known intolerance, sensitivity, or allergy to any ingredients in the study test products * 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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Inquis Clinical Research

    Toronto, Ontario, Canada

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