Ignite Creation Date:
2024-07-17 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479330
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-19
Brief Title:
Evaluating the Impact of Incremental Doses of a Sugar Replacer Blend on Gastrointestinal Tolerance in Chocolate
Sponsor:
Mondelēz International Inc
Organization:
Mondelēz International Inc
Study Overview
Official Title:
Evaluating the Impact of Incremental Doses of a Sugar Replacer Blend on Gastrointestinal Tolerance in Chocolate
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None