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Sugar Replacer

Kestose + cocoa and polydextrose premix dose 2 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
* Body Mass Index (BMI) 18.5-32.0kg/m², inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Awards & highlights

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)

Eligible Conditions
  • Gastrointestinal Tolerance
  • Healthy Population

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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