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Sugar Replacer Blend

Sugar Replacer Blend in Candies 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

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up evaluation performed at time 0, 2, 4, 6, 10 and 24 hours

Awards & highlights

Study Summary

This trial tests how well a blend of sugar substitutes is tolerated in the digestive system at different doses.

Who is the study for?

Healthy individuals aged 18-55 with a BMI of 18.5-32, normal bowel habits, and moderate diet who don't smoke much or use certain drugs can join this study. They must be able to use technology for data collection, follow COVID guidelines, limit alcohol intake, and not be on conflicting medications or have recent major illnesses.Check my eligibility

What is being tested?

The trial is testing how well people tolerate low-sugar candies made with a sugar replacer blend versus regular sugar candies. It's set up so participants randomly try different doses in a single-blind manner where they don't know which type they're getting at each stage.See study design

What are the potential side effects?

Potential side effects may include digestive discomfort such as bloating, gas, diarrhea or constipation due to the body's response to different types of sugars and fiber in the sugar replacer blend used in the low-sugar candies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ evaluation performed at time 0, 2, 4, 6, 10 and 24 hours

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Total Area Under the Curve (tAUC) of composite gastrointestinal Symptom score

Secondary outcome measures

Frequency of Diarrhea within 24 hours

Frequency of composite score > 1 at each time point

Maximum score and time for maximum score for each gastrointestinal symptom

+6 more

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Test low sugar candies dose 3Active Control1 Intervention

82% reduced sugar chewable candy containing Soluble Corn Fiber + Resistant wheat dextrins provided at a dose of 50 g (corresponding to 2 servings)

Group II: Test low sugar candies dose 1Active Control1 Intervention

low-sugar chewable candy containing Soluble Corn Fiber + Inulin + Erythritol provided at a dose of 50 g (corresponding to 2 servings)

Group III: Test low sugar candies dose 2Active Control1 Intervention

64% reduced sugar chewable candy containing Soluble Corn Fiber + Resistant wheat dextrins provided at a dose of 50 g (corresponding to 2 servings)

Group IV: Control sugar candiesPlacebo Group1 Intervention

Control chewable candy made with sugar and provided at a dose of 50 g (corresponding to 2 servings)

Do I qualify?Apply below to find out

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Who is running the clinical trial?

INQUIS Clinical Research Ltd.Industry Sponsor

7 Previous Clinical Trials

235 Total Patients Enrolled

Mondelēz International, Inc.Lead Sponsor

32 Previous Clinical Trials

1,671 Total Patients Enrolled

INQUIS Clinical ResearchIndustry Sponsor

9 Previous Clinical Trials

265 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for individuals under 40 years of age to partake in this clinical investigation?

"This trial has established the age range of 18-55 as its inclusion criteria for participants."

Answered by AI

Is it possible to still apply for this clinical investigation?

"Per clinicaltrials.gov, this medical investigation is no longer accepting participants. It was first published on September 12th 2023 and last modified five days later. Fortunately, there are 5 other trials that have open recruitment as of now."

Answered by AI

Am I able to register for participation in this experiment?

"This investigation is searching for 60 guinea pigs, aged between 18-55 who presently have digestive tract tolerance. Other essential requirements include: nonpregnant/nonlactating healthful individuals with a BMI of 18.5-32.0kg/m²; no major medical issues, accidents or operations necessitating hospitalisation in the three months prior to screening; capacity to understand the trial methods and agreeableness to give knowledgeable approval for taking part; smokers limited to <10 cigarettes per day that are happy not altering their nicotine consumption during the study period; maximum alcohol intake of ≤3 standard drinks daily and ≤7 weekly;"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Evaluating the Impact of Incremental Doses of a Sugar Replacer Blend on Gastrointestinal Tolerance in Candies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05827198.