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Sugar Replacer

Sugar Replacers in Chocolate for Gastrointestinal Tolerance

N/A
Waitlist Available
Research Sponsored by Mondelēz International, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Non-pregnant, non-lactating, healthy individuals aged 18-55 years, inclusive
Be between 18 and 65 years old
Must not have
Chronic moderate to severe gastrointestinal symptoms
Use of systemic antibiotics, antifungals or antiparasitics in the past 3 months and during the experimental period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Awards & highlights

Summary

This trial will test different sugar substitutes to see how well they are tolerated by the stomach.

Who is the study for?
Healthy adults aged 18-55, with a BMI of 18.5-32 kg/m², who haven't been hospitalized recently and don't smoke heavily or consume much alcohol. They must be able to use technology for data collection, not use marijuana/hemp products, have normal bowel movements, eat limited fruits/vegetables and whole grains, can receive income in Canada and follow COVID guidelines.
What is being tested?
The trial is testing how well people tolerate different doses of sugar replacers in chocolate. It's a randomized study where participants won't know which blend they're getting. The blends include maltitol, kestose (Oligofructose), kestose + cocoa mix and polydextrose premix.
What are the potential side effects?
Possible side effects may include digestive issues like bloating, gas, discomfort or changes in bowel habits due to the sugar replacer ingredients being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 55 years old, not pregnant, and not breastfeeding.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I often have severe stomach or bowel problems.
Select...
I haven't taken antibiotics, antifungals, or antiparasitics in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluation performed at time 0, 2, 4, 6, 10 and 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Total Area Under the Curve (tAUC) of composite gastrointestinal Symptom score
Secondary study objectives
Frequency of Diarrhea within 24 hours
Frequency of composite score > 1 at each time point
Maximum score for abdominal bloating
+21 more

Trial Design

5Treatment groups
Active Control
Placebo Group
Group I: Kestose + cocoa and polydextrose premix dose 2 chocolateActive Control1 Intervention
Millk chocolate with kestose oligofructose + cocoa and polydextrose premix dose 2 replacing all sugar at a dose of 45 g (2 servings)
Group II: Kestose + cocoa and polydextrose premix dose 1 chocolateActive Control1 Intervention
Millk chocolate with kestose oligofructose + cocoa and polydextrose premix dose 1 replacing all sugar at a dose of 45 g (2 servings)
Group III: Maltitol chocolateActive Control1 Intervention
Milk chocolate with maltitol replacing all sugar at a dose of 45 g (2 servings)
Group IV: Kestose chocolateActive Control1 Intervention
Milk chocolate with kestose oligofructose replacing all sugar at a dose of 45 g (2 servings)
Group V: Control chocolate with sugarPlacebo Group1 Intervention
Milk chocolate made with sugar at a dose of 45 g (2 servings)

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Who is running the clinical trial?

Mondelēz International, Inc.Lead Sponsor
33 Previous Clinical Trials
1,731 Total Patients Enrolled
INQUIS Clinical ResearchIndustry Sponsor
10 Previous Clinical Trials
325 Total Patients Enrolled
~20 spots leftby Oct 2024
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