NCT05827198

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

September 12, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2024

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

3 months

First QC Date

March 14, 2023

Last Update Submit

September 5, 2023

Conditions

Gastrointestinal ToleranceHealthy Population

Keywords

Sugar replacerGastrointestinal symptomsBHD-BSSGITQAcute

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Total Area Under the Curve of each individual gastrointestinal symptom

    tAUC between 0 and 24 hours

  • Frequency of composite score > 1 at each time point

    Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours

  • Frequency of Diarrhea within 24 hours

    Evaluation performed over 24 hour after consumption of study products

  • Maximum score and time for maximum score for each gastrointestinal symptom

    Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours

  • Number of bowel movements

    Evaluation performed over 24 hour after consumption of study products

  • +4 more secondary outcomes

Study Arms (4)

Control sugar candies

PLACEBO COMPARATOR

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

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)

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)

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)

Other: Low-sugar candies compared to regular sugar candies

Interventions

Low-sugar candies compared to regular sugar candiesOTHER

Acute intake

Control sugar candiesTest low sugar candies dose 1Test low sugar candies dose 2Test low sugar candies dose 3

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inquis Clinical Research

Toronto, Ontario, Canada

Location

Central Study Contacts

Thomas MS Wolever, aMD, PhD

CONTACT

416-861-9177twolever@inquis.com

Alexandra Meynier, PhD

CONTACT

+33 (0)1 83 11 45 68alexandra.meynier@mdlz.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The products will be labelled with a code and participants will not be informed which test meal is which. However, since the portion sizes of some of the treatments differ, some information about them may be available to participants and study coordinators; that is why we have termed the study "single blind". Single blinding will be achieved by identifying the treatments by code on the case report forms and in the database, so that those doing the statistical analysis and the study sponsor will be unaware of the treatment assignments.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2023

First Posted

April 24, 2023

Study Start

September 12, 2023

Primary Completion

December 22, 2023

Study Completion

January 27, 2024

Last Updated

September 8, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)