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Evaluating the Impact of Different Sugar Replacer Combinations on Gastrointestinal Tolerance

NCT05794100 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-04-03

No results posted yet for this study

Summary

This study is a randomized, double-blind, crossover trial aiming at evaluating the gastrointestinal tolerance of 3 sugar replacers mixes at 3 different doses. The investigators will also try to understand the factors that could explain the presence or absence of symptoms

Conditions

  • Tolerance
  • Healthy Population

Interventions

OTHER

Acute intake of one of the products (active comparator 1 to 9) or Placebo comparator

One pack of each product (1 to 10) will be consumed on a separate occasion

Sponsors & Collaborators

  • BioFortis

    collaborator OTHER

  • Mondelēz International, Inc.

    lead INDUSTRY

Principal Investigators

  • Kathleen M Kelley, MD · BioFortis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-11
Primary Completion
2022-05-30
Completion
2022-07-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05794100 on ClinicalTrials.gov