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

Mondelez International

Status: Not yet enrolling

Conditions: Healthy Population; Gastrointestinal Tolerance

Treatments: Other: Milk Chocolate

Study type: Interventional

Funder types: Industry

Identifiers

NCT06479330

KBE070 / INQ-2402

Details and patient eligibility

About

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)

Full description

The study will have a randomized, double-blind, crossover design with 5 visits consisting of one screening visit and 5 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 4 test products made with the sugar replacer ingredients or blend of ingredients 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, 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 Bristol Stool Scale (BSS).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Non-pregnant, non-lactating, healthy individuals aged 18-55 years, inclusive
• Body Mass Index (BMI) 18.5-32.0kg/m², inclusive
• No major illness, trauma or surgery requiring hospitalization within 3 months 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/day 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/day of fruits and vegetables combined and ≤3 (women) or ≤4 (men) servings/day 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 (Ontario Health Insurance Plan)
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

60 participants in 5 patient groups, including a placebo group

Control chocolate with sugar

Placebo Comparator group

Description:

Milk chocolate made with sugar at a dose of 45 g (2 servings)

Treatment:

Other: Milk Chocolate

Maltitol chocolate

Active Comparator group

Description:

Milk chocolate with maltitol replacing all sugar at a dose of 45 g (2 servings)

Treatment:

Other: Milk Chocolate

Kestose chocolate

Active Comparator group

Description:

Milk chocolate with kestose oligofructose replacing all sugar at a dose of 45 g (2 servings)

Treatment:

Other: Milk Chocolate

Kestose + cocoa and polydextrose premix dose 1 chocolate

Active Comparator group

Description:

Millk chocolate with kestose oligofructose + cocoa and polydextrose premix dose 1 replacing all sugar at a dose of 45 g (2 servings)

Treatment:

Other: Milk Chocolate

Kestose + cocoa and polydextrose premix dose 2 chocolate

Active Comparator group

Description:

Millk chocolate with kestose oligofructose + cocoa and polydextrose premix dose 2 replacing all sugar at a dose of 45 g (2 servings)

Treatment:

Other: Milk Chocolate