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

Launched by MONDELĒZ INTERNATIONAL, INC. · Apr 11, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how well a blend of sugar replacers, made up of inulin, soluble corn fiber, and erythritol, is tolerated by healthy adults when consumed in different amounts. The study will involve healthy individuals aged 18 to 55 years who have normal bowel habits and meet other specific health criteria. Participants will be randomly assigned to try different doses of the sugar replacer blend, and the study will help determine how their bodies react to it.

To join the trial, participants should be in good health, not pregnant or breastfeeding, and should not have any serious medical conditions. They also need to be willing to limit alcohol and avoid certain substances like marijuana during the study. Participants will use a smartphone, tablet, or computer to track their experience. The study is not yet recruiting, but those who qualify will contribute to understanding how sugar alternatives might affect digestion.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Non-pregnant, non-lactating, healthy individuals aged 18-55 years, inclusive
• • BMI 18.5-32.0kg/m², inclusive
• • No major illness, trauma or surgery requiring hospitalization within 3mo 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/d 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/d of fruits and vegetables combined and ≤3 (women) or ≤4 (men) servings/d 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
• • 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