NCT07372482

Evaluating the Impact of Fat and Sugar Replacer Blends on Gastrointestinal Tolerance in Biscuits

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (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 and bowel habits of sugar- and fat- replacer ingredients and blends (maltitol, polydextrose, allulose and EPG)

Detailed description

The study will have a randomized, double-blind, crossover design with 8 visits consisting of one screening visit and 7 study visits (3 to 14-day interval between the start of each visit) across 4-12 weeks. Participants will be randomized to a test sequence and, during the course of the study, will complete 7 trial arms. At each visit eligible participants will come to INQUIS between 8-11am, and \~1-2h after consuming their usual breakfast at home. After rating the severity of GI symptoms, participants will consume one of the investigational products with a drink of water (250ml) and then be free to leave. The severity of 11 symptoms will be rated at 0, 2, 4, 6, 10 and 24h: Abdominal bloating, Abdominal pain, Gas/flatulence, Gas with discharge, Burping, Reflux (heartburn), Stomach rumbling (borborygmus), Urgency of bowel movement, Oily spotting (leakage), Nausea and Vomiting. The severity of each symptom will be rated by the subject as None, Mild, Moderate or Severe (these ratings will be assigned scores of 0, 1, 2 or 3, respectively). For each bowel movement (BM) passed during the 24h period, participants will be asked to record: the time, if they had to strain (yes or no), if they experienced discomfort (yes or no), if they felt there was incomplete evacuation (yes or no), if they had oily evacuation (oil separated from the stools) (yes or no), if they had oily stool (oily lumps in the stool) (yes or no) and the consistency of the stool rated using the using the Bristol Stool Scale (BSS).

Conditions

• Gastrointestinal Tolerance
• Healthy Population

Interventions

Type	Name	Description
OTHER	Test sandwiched biscuits with creme	Acute intake
OTHER	Control sandwiched biscuit with sugar	Acute intake

Timeline

• Start date: 2025-10-28
• Primary completion: 2026-02-27
• Completion: 2026-02-27
• First posted: 2026-01-28
• Last updated: 2026-03-27

Locations

1 site across 1 country: Canada