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

Gastrointestinal Tolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05827198
• Other study ID #: KBE067 / INQ-2239
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 12, 2023
• Est. completion date: January 27, 2024

Study information

• Verified date: September 2023
• Source: Mondelez International, Inc.
• Contact: Thomas MS Wolever, aMD, PhD
• Phone: 416-861-9177
• Email: twolever[@]inquis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 27, 2024
• Est. primary completion date: December 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Tolerance
• Healthy Population

Intervention

Other:
• Low-sugar candies compared to regular sugar candies
Acute intake

Locations

Country	Name	City	State
Canada	Inquis Clinical Research	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Mondelez International, Inc.	INQUIS Clinical Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of bowel movements	Number of bowel movements over the 24 hours	Evaluation performed over 24 hour after consumption of study products
Secondary	straining during bowel movement	Proportion of participants having to strain or not	Evaluation performed over 24 hour after consumption of study products
Secondary	discomfort during bowel movement	Proportion of participants having discomfort or not	Evaluation performed over 24 hour after consumption of study products
Secondary	incomplete evacuation	Proportion of participants declaring incomplete evacuation or not	Evaluation performed over 24 hour after consumption of study products
Secondary	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