NCT05794100

Evaluating the Impact of Different Sugar Replacer Combinations on Gastrointestinal Tolerance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Mondelēz International, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized, double-blind, crossover trial aiming at evaluating the gastrointestinal tolerance of 3 sugar replacers mixes at 3 different doses. The investigators will also try to understand the factors that could explain the presence or absence of symptoms

Detailed description

This study is a randomized, double-blind, crossover trial with 23 visits consisting of one screening visit, one baseline visit, and 21 study visits (10 test periods each consisting of 2 test visits and one drop-off visit) across 11 weeks. For this study, 60 generally healthy subjects will be randomized to a test sequence and will consume one control product and nine test products over the course of the study. Before consumption of any study products, breath hydrogen lactulose assessment and collection of stool samples for microbiome analysis will be completed. Additionally, midway through the study, data will be reviewed in a blinded manner and a stool sample will be collected from a subset of 30 subjects for in vitro fermentation tests. Gastrointestinal symptoms and stool information will be collected using the Gastrointestinal Tolerance Questionnaire (GITQ) and Bowel Habit Diary with Bristol Stool Scale (BHD-BSS). The GITQ and BHD-BSS will be administered for 3 days and 7 days prior to study product consumption, respectively. Additionally, the GITQ and BHD-BSS will be collected throughout the day of study product consumption and the 2 days after product consumption. 24-h urine samples will be collected after study product consumption for urinary allulose analysis.

Conditions

• Tolerance
• Healthy Population

Interventions

Type	Name	Description
OTHER	Acute intake of one of the products (active comparator 1 to 9) or Placebo comparator	One pack of each product (1 to 10) will be consumed on a separate occasion

Timeline

• Start date: 2021-10-11
• Primary completion: 2022-05-30
• Completion: 2022-07-30
• First posted: 2023-04-03
• Last updated: 2023-04-03

Locations

1 site across 1 country: United States