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

This study is a randomized, single-blind, crossover trial aiming at evaluating the gastrointestinal tolerance of a sugar replacer blend (inulin + soluble corn fiber + erythritol) at 3 different doses

Study Overview

• Status: Not yet recruiting
• Conditions: Gastrointestinal Tolerance; Healthy Population
• Intervention / Treatment: Other: Low-sugar candies compared to regular sugar candies

Detailed Description

The study will have a randomized, single-blind, crossover design with 5 visits consisting of one screening visit and 4 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 3 test products made with the sugar replacer blend 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/discomfort, Gas/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 using the Bristol Stool Scale (BSS).

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas MS Wolever, aMD, PhD; Phone Number: 416-861-9177; Email: twolever@inquis.com
• Study Contact Backup: Name: Alexandra Meynier, PhD; Phone Number: +33 (0)1 83 11 45 68; Email: alexandra.meynier@mdlz.com

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Inquis Clinical research
      • Contact: Thomas MS Wolever, MD, PhD; Phone Number: 416-861-9177; Email: twolever@inquis.com
      • Contact: Janice Campbell, MSc; Phone Number: 416-861-0506; Email: jcampbell@inquis.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Non-pregnant, non-lactating, healthy individuals aged 18-55 years, inclusive
• BMI 18.5-32.0kg/m², inclusive
• No major illness, trauma or surgery requiring hospitalization within 3mo of the screening visit
• Ability to understand the study procedures and willing to provide informed consent to participate in the study
• Non-smokers or smokers who smoke <10 cigarettes/day and are willing not to change nicotine habits during the study period
• Willing to limit alcohol consumption to ≤3 standard drinks/d and ≤7 standard drinks/week during the study period
• Willing to refrain from any marijuana or hemp products during the study period
• Normal bowel habits (>2 bowel movements/week and <3 bowel movements per day)
• Consumes ≤4 servings/d of fruits and vegetables combined and ≤3 (women) or ≤4 (men) servings/d of whole grains using the definitions of "serving" .
• Participants must have a cell phone/tablet/computer and be willing and able to use it to collect study data
• Participants must be eligible to receive income in Canada and be covered by a health insurance plan such as OHIP
• Participants are willing to follow current COVID guidelines with respect to attending study visits

Exclusion Criteria:

• Failure to meet any one of the inclusion criteria
• Chronic moderate to severe gastrointestinal symptoms
• Use of systemic antibiotics, antifungals or antiparasitics in the past 3 months and during the experimental period
• Use of medications, supplements, and products which may affect the results (laxative, anti-diarrhea, anti-constipation drugs, high fiber supplements)
• Individuals with any medical conditions or use of supplements or medications that increase risk to the subject or others or may affect the results, as judged by the Principal Investigator
• Unwillingness or inability to comply with the experimental procedures and to follow INQUIS safety guidelines
• Known intolerance, sensitivity, or allergy to any ingredients in the study test products
• Subject is currently participating or recently (within 30 days of screening) participated in a clinical trial involving long-term exposure (greater than 24 hours) to an investigational drug, nutritional supplement, or lifestyle modification

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control sugar candies; Control chewable candy made with sugar and provided at a dose of 50 g (corresponding to 2 servings)	Other: Low-sugar candies compared to regular sugar candies; Acute intake
Active Comparator: Test low sugar candies dose 1; low-sugar chewable candy containing Soluble Corn Fiber + Inulin + Erythritol provided at a dose of 50 g (corresponding to 2 servings)	Other: Low-sugar candies compared to regular sugar candies; Acute intake
Active Comparator: Test low sugar candies dose 2; 64% reduced sugar chewable candy containing Soluble Corn Fiber + Resistant wheat dextrins provided at a dose of 50 g (corresponding to 2 servings)	Other: Low-sugar candies compared to regular sugar candies; Acute intake
Active Comparator: Test low sugar candies dose 3; 82% reduced sugar chewable candy containing Soluble Corn Fiber + Resistant wheat dextrins provided at a dose of 50 g (corresponding to 2 servings)	Other: Low-sugar candies compared to regular sugar candies; Acute intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Area Under the Curve (tAUC) of composite gastrointestinal Symptom score	total area under the curve (tAUC) of the composite GastroIntestinal symptom score (sum of the scores for the 8 GI symptoms). The score values can range from 0 up to 24 with the higher values showing the higher levels of symptoms (worse conditions).	tAUC between 0 and 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Area Under the Curve of each individual gastrointestinal symptom	Total Area Under the Curve of each of the individual 8 gastrointestinal symptoms. Each symptom range from 0 up to 3 with 3 showing the highest / worse condiiton of symptoms	tAUC between 0 and 24 hours
Frequency of composite score > 1 at each time point	Proportion of participants who have a composite GastoInestinal symptom score >1 (moderate-to-severe) at each time point. The composite score can range from 0 up to 24 with the higher values showing the higher levels of symptoms (worse conditions).	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Frequency of Diarrhea within 24 hours	Proportion of participants with diarrhea, defined as 3 or more type 6 or 7 stools (based on the BSS) within the 24 hour period after consumption of the study products	Evaluation performed over 24 hour after consumption of study products
Maximum score and time for maximum score for each gastrointestinal symptom	For each individual GI symptom: the proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point, the maximum detected score (which can range from 0 up to 3) and the time of the maximum score	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Number of bowel movements	Number of bowel movements over the 24 hours	Evaluation performed over 24 hour after consumption of study products
straining during bowel movement	Proportion of participants having to strain or not	Evaluation performed over 24 hour after consumption of study products
discomfort during bowel movement	Proportion of participants having discomfort or not	Evaluation performed over 24 hour after consumption of study products
incomplete evacuation	Proportion of participants declaring incomplete evacuation or not	Evaluation performed over 24 hour after consumption of study products
Stool consistency based on britol stool scale	mean stool consistency on Bristol Stool Scale (BSS). The scale provide values from 1 to 7 depending on the type of stool with 1 being the driest stools and 7 the most liquid one.	Evaluation performed over 24 hour after consumption of study products

Collaborators and Investigators

• Sponsor: Mondelēz International, Inc.
• Collaborators: INQUIS Clinical Research

Study record dates

Study Major Dates

• Study Start (Estimated): September 12, 2023
• Primary Completion (Estimated): December 22, 2023
• Study Completion (Estimated): January 27, 2024

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Gastrointestinal symptoms; Acute; Sugar replacer; GITQ; BHD-BSS
• Other Study ID Numbers: KBE067 / INQ-2239

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No