Evaluating the Impact of Incremental Doses of a Sugar Replacer Blend on Gastrointestinal Tolerance in Chocolate

Launched by MONDELĒZ INTERNATIONAL, INC. · Jun 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well different sugar replacers, which are ingredients used to make sweets taste sweet without actual sugar, are tolerated by the digestive system when added to chocolate. The trial will look at various blends of these sugar replacers in healthy individuals to see if they can enjoy chocolate without experiencing any gastrointestinal discomfort, like bloating or gas.

To participate, you need to be a healthy adult between the ages of 18 and 55, with a body weight that falls within a normal range. You should not have any serious medical conditions or have recently taken certain medications that could affect your digestion. If you join, you will be asked to keep track of your experience with the chocolate products over a set period. Please note that you will need access to a mobile device to help collect data for the study, and you will have to follow specific guidelines regarding smoking, alcohol, and diet during the trial. This trial is not yet recruiting participants, but it aims to provide valuable information on how these sugar replacers affect our gut health.

Gender

ALL

Eligibility criteria

• 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