Gastrointestinal ToleranceNCT05827198
Evaluating the Impact of Incremental Doses of a Sugar Replacer Blend on Gastrointestinal Tolerance in Candies
A study testing Low-sugar candies compared to regular sugar candies in people with Gastrointestinal Tolerance and Healthy Population, run by Mondelēz International, Inc. at 1 site in Canada.
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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Tolerance, Healthy Population
- What is being tested?
- Low-sugar candies compared to regular sugar candies
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 12 Sep 2023to 27 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site
Inquis Clinical Research
Toronto, Ontario
Thomas MS Wolever, MD, PhD, 416-861-9177, twolever@inquis.com
Janice Campbell, MSc, 416-861-0506, jcampbell@inquis.com
About this study
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
Read the 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).
- Conditions
- Gastrointestinal Tolerance, Healthy Population
- Being tested
- Low-sugar candies compared to regular sugar candies
- Keywords
- Sugar replacer, Gastrointestinal symptoms, BHD-BSS, GITQ, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-sugar candies compared to regular sugar candiesOther
Acute intake
| Study group | Role | What they receive |
|---|---|---|
| Control sugar candies | Placebo comparator | Control chewable candy made with sugar and provided at a dose of 50 g (corresponding to 2 servings) Receives: Other: Low-sugar candies compared to regular sugar candies |
| Test low sugar candies dose 1 | Active comparator | low-sugar chewable candy containing Soluble Corn Fiber + Inulin + Erythritol provided at a dose of 50 g (corresponding to 2 servings) Receives: Other: Low-sugar candies compared to regular sugar candies |
| Test low sugar candies dose 2 | Active comparator | 64% reduced sugar chewable candy containing Soluble Corn Fiber + Resistant wheat dextrins provided at a dose of 50 g (corresponding to 2 servings) Receives: Other: Low-sugar candies compared to regular sugar candies |
| Test low sugar candies dose 3 | Active comparator | 82% reduced sugar chewable candy containing Soluble Corn Fiber + Resistant wheat dextrins provided at a dose of 50 g (corresponding to 2 servings) Receives: Other: Low-sugar candies compared to regular sugar candies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: tAUC between 0 and 24 hours
Secondary outcomes (9)
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
Measured: 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).
Measured: 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
Measured: 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
Measured: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Number of bowel movements
Number of bowel movements over the 24 hours
Measured: Evaluation performed over 24 hour after consumption of study products
straining during bowel movement
Proportion of participants having to strain or not
Measured: Evaluation performed over 24 hour after consumption of study products
discomfort during bowel movement
Proportion of participants having discomfort or not
Measured: Evaluation performed over 24 hour after consumption of study products
incomplete evacuation
Proportion of participants declaring incomplete evacuation or not
Measured: 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.
Measured: Evaluation performed over 24 hour after consumption of study products
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start12 Sep 2023 (estimated)
- Primary completion22 Dec 2023 (estimated)
- Study completion27 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In a 4-way cross-over, there is a set of 4 balanced sequences to which participants will be randomly assigned (ABCD, BADC, CDAB, DCBA). Blocks of 2, 3, or 4 sets of sequences were randomly ordered to create a balanced sequence for n=60 participants. Orders will be assigned to participants in the order they attended for the first visit after being recruited.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mondelēz International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- INQUIS Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827198
- Sponsor's protocol ID
- KBE067 / INQ-2239
- Status last verified
- Sep 2023
- First submitted
- 14 Mar 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Incremental Doses of a Sugar Replacer Blend on Gastrointestinal Tolerance in Candies
- ClinicalTrials.gov ID
- NCT05827198
- Acronym / sponsor ID
- KBE067 / INQ-2239
- Conditions
- Gastrointestinal Tolerance, Healthy Population
- Keywords
- Sugar replacer, Gastrointestinal symptoms, BHD-BSS, GITQ, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mondelēz International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- INQUIS Clinical Research
- Study start
- 12 Sep 2023 (estimated)
- Primary completion
- 22 Dec 2023 (estimated)
- Study completion
- 27 Jan 2024 (estimated)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- In a 4-way cross-over, there is a set of 4 balanced sequences to which participants will be randomly assigned (ABCD, BADC, CDAB, DCBA). Blocks of 2, 3, or 4 sets of sequences were randomly ordered to create a balanced sequence for n=60 participants. Orders will be assigned to participants in the order they attended for the first visit after being recruited.
| Arm | Type | Receives |
|---|---|---|
| Control sugar candies | Placebo comparator | Other: Low-sugar candies compared to regular sugar candiesControl chewable candy made with sugar and provided at a dose of 50 g (corresponding to 2 servings) |
| Test low sugar candies dose 1 | Active comparator | Other: Low-sugar candies compared to regular sugar candieslow-sugar chewable candy containing Soluble Corn Fiber + Inulin + Erythritol provided at a dose of 50 g (corresponding to 2 servings) |
| Test low sugar candies dose 2 | Active comparator | Other: Low-sugar candies compared to regular sugar candies64% reduced sugar chewable candy containing Soluble Corn Fiber + Resistant wheat dextrins provided at a dose of 50 g (corresponding to 2 servings) |
| Test low sugar candies dose 3 | Active comparator | Other: Low-sugar candies compared to regular sugar candies82% reduced sugar chewable candy containing Soluble Corn Fiber + Resistant wheat dextrins provided at a dose of 50 g (corresponding to 2 servings) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-sugar candies compared to regular sugar candiesAcute intake | Other | Control sugar candies, Test low sugar candies dose 1, Test low sugar candies dose 2, Test low sugar candies dose 3 |
Primary outcome
Total Area Under the Curve (tAUC) of composite gastrointestinal Symptom score
Time frame: tAUC between 0 and 24 hours
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).
9 secondary outcomes
Total Area Under the Curve of each individual gastrointestinal symptom
Time frame: tAUC between 0 and 24 hours
Frequency of composite score > 1 at each time point
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Frequency of Diarrhea within 24 hours
Time frame: Evaluation performed over 24 hour after consumption of study products
Maximum score and time for maximum score for each gastrointestinal symptom
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Number of bowel movements
Time frame: Evaluation performed over 24 hour after consumption of study products
straining during bowel movement
Time frame: Evaluation performed over 24 hour after consumption of study products
discomfort during bowel movement
Time frame: Evaluation performed over 24 hour after consumption of study products
incomplete evacuation
Time frame: Evaluation performed over 24 hour after consumption of study products
Stool consistency based on britol stool scale
Time frame: Evaluation performed over 24 hour after consumption of study products
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-sugar candies compared to regular sugar candies in people with Gastrointestinal Tolerance and Healthy Population, run by Mondelēz International, Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas MS Wolever, aMD, PhD (416-861-9177, twolever@inquis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Area Under the Curve (tAUC) of composite gastrointestinal Symptom score (time frame: tAUC between 0 and 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.