Evaluating the Impact of Fat and Sugar Replacer Blends on Gastrointestinal Tolerance in Biscuits

Mondelēz International, Inc.56 enrolled

Overview

This study is a randomized, double-blind, crossover trial aiming at evaluating the gastrointestinal tolerance and bowel habits of sugar- and fat- replacer ingredients and blends (maltitol, polydextrose, allulose and EPG)

The study will have a randomized, double-blind, crossover design with 8 visits consisting of one screening visit and 7 study visits (3 to 14-day interval between the start of each visit) across 4-12 weeks. Participants will be randomized to a test sequence and, during the course of the study, will complete 7 trial arms. At each visit eligible participants will come to INQUIS between 8-11am, and \~1-2h after consuming their usual breakfast at home. After rating the severity of GI symptoms, participants will consume one of the investigational products with a drink of water (250ml) and then be free to leave. The severity of 11 symptoms will be rated at 0, 2, 4, 6, 10 and 24h: Abdominal bloating, Abdominal pain, Gas/flatulence, Gas with discharge, Burping, Reflux (heartburn), Stomach rumbling (borborygmus), Urgency of bowel movement, Oily spotting (leakage), Nausea and Vomiting. The severity of each symptom will be rated by the subject as None, Mild, Moderate or Severe (these ratings will be assigned scores of 0, 1, 2 or 3, respectively). For each bowel movement (BM) passed during the 24h period, participants will be asked to record: the time, if they had to strain (yes or no), if they experienced discomfort (yes or no), if they felt there was incomplete evacuation (yes or no), if they had oily evacuation (oil separated from the stools) (yes or no), if they had oily stool (oily lumps in the stool) (yes or no) and the consistency of the stool rated using the using the Bristol Stool Scale (BSS).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Gastrointestinal Tolerance Healthy Population

Interventions

Test sandwiched biscuits with cremeOTHER

Acute intake

Control sandwiched biscuit with sugarOTHER

Acute intake

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Inquis Clinical Research

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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 11 GI symptoms). The score values can range from 0 up to 24 with the higher values showing the higher levels of symptoms (worse conditions).

Time frame: tAUC between 0 and 24 hours

Secondary Outcomes

Total Area Under the Curve of each individual gastrointestinal symptom

Total Area Under the Curve of each of the individual 11 gastrointestinal symptoms (Abdominal bloating, Abdominal pain, Gas/flatulence, Gas with discharge, Burping, Reflux (heartburn), Stomach rumbling (borborygmus), Urgency of bowel movement, Oily spotting (leakage), Nausea and Vomiting). Each symptom range from 0 up to 3 with 3 showing the highest / worse condiiton of symptoms

Time frame: 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)