NCT06479330

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

• 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 sugar replacer ingredients and blends (maltitol, kestose (Oligofructose), kestose + cocoa and polydextrose premix at different doses)

Detailed description

The study will have a randomized, double-blind, crossover design with 5 visits consisting of one screening visit and 5 study visits (3-14-day interval between the start of each visit) across 2-8 weeks. Participants will be randomized to a test sequence and will consume one control product and 4 test products made with the sugar replacer ingredients or blend of ingredients over the course of the study. At each visit, eligible participants will come to the lab between 8-11am, and \~1-2 hours after consuming their usual breakfast at home. After rating the severity of gastrointestinal symptoms, participants will consume one of the investigational products with a drink of water (250ml) and then be free to leave. The severity of 8 gastrointestinal symptoms (abdominal bloating, abdominal pain, flatulence, burping, reflux (heartburn), stomach rumbling (borborygmus), nausea and vomiting) will be rated at 2, 4, 6, 10 and 24 hours after starting to eat. Over the 24 hour period following consuming the investigational product a Bowel Habit Diary will be kept. For each bowel movement passed during the 24 hour period, participants will be asked to record: the time, if they had to strain, if they experienced discomfort, if they felt there was incomplete evacuation and the consistency of the stool rated using the Bristol Stool Scale (BSS).

Conditions

• Gastrointestinal Tolerance
• Healthy Population

Interventions

Type	Name	Description
OTHER	Milk Chocolate	Acute intake

Timeline

• Start date: 2024-07-09
• Primary completion: 2024-10-16
• Completion: 2024-12-20
• First posted: 2024-06-28
• Last updated: 2026-04-01

Locations

1 site across 1 country: Canada