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Evaluating the Impact of Different Sugar Replacer Combinations on Gastrointestinal Tolerance

NCT05794100•Mondelēz International, Inc.

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

Detailed Description

This study is a randomized, double-blind, crossover trial with 23 visits consisting of one screening visit, one baseline visit, and 21 study visits (10 test periods each consisting of 2 test visits and one drop-off visit) across 11 weeks. For this study, 60 generally healthy subjects will be randomized to a test sequence and will consume one control product and nine test products over the course of the study. Before consumption of any study products, breath hydrogen lactulose assessment and collection of stool samples for microbiome analysis will be completed. Additionally, midway through the study, data will be reviewed in a blinded manner and a stool sample will be collected from a subset of 30 subjects for in vitro fermentation tests. Gastrointestinal symptoms and stool information will be collected using the Gastrointestinal Tolerance Questionnaire (GITQ) and Bowel Habit Diary with Bristol Stool Scale (BHD-BSS). The GITQ and BHD-BSS will be administered for 3 days and 7 days prior to study product consumption, respectively. Additionally, the GITQ and BHD-BSS will be collected throughout the day of study product consumption and the 2 days after product consumption. 24-h urine samples will be collected after study product consumption for urinary allulose analysis.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Male or female, 18-55 years of age, inclusive at Visit 1 (Day -11).
•2. BMI of 18.5 to 32.0 kg/m2, inclusive, at Visit 1 (Day -11).
•3. Have normal bowel movement habit (\<3 bowel movements/d to \>2 bowel movements/week) based on the BHD-BSS collected at Visit 2 (Day -4).
•4. Consumes fiber at an amount no more than the average American diet \[based on consumption of high-fiber containing plant-based foods (e.g., fruits, vegetables, legumes, pulses, nuts, and products labeled as good or excellent sources of fiber)\].
•5. Smokes 10 cigarettes or less in a day and has no plan to change nicotine habits during the study period.
•6. Non-user or former users (cessation ≥12 mo) of any marijuana or hemp products and has no plans to use marijuana or hemp products during the study period.
•7. Willing to maintain habitual dietary, lifestyle, and physical activity (with exceptions per study instructions) throughout the trial and willing to adhere to dietary, lifestyle, and physical activity requirements of the study.
•8. Willing to limit alcohol consumption to ≤3 standard drinks/d and ≤7 standard drinks/week throughout the trial.
•9. Willing to refrain from exclusionary medications, supplements, and products throughout the study.
•10. No health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history and routine laboratory test results.
+1 more criteria

Exclusion Criteria

•1. Moderate or severe GI symptoms or 3-d total score of \>2 for any individual GI symptom based on the baseline GITQ collected at Visit 2 (Day -4). Mild burping and/or flatulence totaling a 3-d score of \>2 is acceptable.
•2. Has a clinically significant GI-related reaction towards GI symptom-causing foods (e.g., beans and legumes, vegetables high in inulin, sodas or fruit drinks, sugar alcohols, inulin, fructooligosaccharides, gluten, and dairy products \[see Appendix 3\]) as judged by the Clinical Investigator.
•3. Female subjects who typically experience change in GI symptoms or bowel habits (e.g., increased or decreased laxation, bloating, abdominal cramping) at the time of menstruation. Subjects with these issues may be included if they are able to reliably predict the onset and duration of their menstruation-related symptoms (e.g., always occur only during the first two days of menses), in the judgment of the Clinical Investigator. Test visits will be scheduled around menses.
•4. Female subjects who is unwilling to wear a tampon during the collection of the 24-h urine samples when these collections occur during the time of menstruation.
•5. Abnormal laboratory test results of clinical significance at Visit 1 (Day -11), at the discretion of the Clinical Investigator. One re-test will be allowed on a separate day prior to Visit 2 (Day -4), for subjects with abnormal laboratory test results.
•6. Clinically important GI condition that would potentially interfere with the evaluation of the study products (e.g., inflammatory bowel disease, irritable bowel syndrome, gastric reflux, indigestion, dyspepsia, Crohn's disease, celiac disease, history of surgery for weight loss, gastroparesis, and clinically significant lactose or gluten intolerance or other food or ingredient allergies).
•7. Recent (within 2 weeks of Visit 1; Day -11) history of an episode of acute GI illness such as nausea/vomiting or diarrhea (defined as ≥3 loose or liquid stools/d).
•8. Self-reported history (within 6 weeks of Visit 1; Day -11) of constipation or diarrhea at the discretion of the Clinical Investigator.
•9. Uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine (including Type 1 and Type 2 diabetes mellitus), hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and/or anxiety disorders) or biliary disorders. Conditions which are well-controlled or resolved will be assessed by the Clinical Investigator on a case-by-case basis.
•10. Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at Visit 1 (Day -11). One re-test will be allowed on a separate day prior to Visit 2 (Day 0), for subjects whose blood pressure exceeds either of these cut points at Visit 1 (Day -11), in the judgment of the Clinical Investigator. If taken, the repeat blood pressure measurement will be used to determine eligibility. Stable use of hypertension medication is allowed \[defined as no change in medication regimen within the 3 mo prior to Visit 1 (Day -11)\].
+16 more criteria

Locations (1)

Biofortis Innovation Services

Addison, Illinois, United States

Key Dates

Start Date

October 11, 2021

Primary Completion Date

May 30, 2022

Completion Date

July 30, 2022

Last Updated

April 3, 2023

Enrollment

ACTUAL participants

Conditions

ToleranceHealthy Population

Interventions

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

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 3, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluating the Impact of Different Sugar Replacer Combinations on Gastrointestinal Tolerance

Inclusion Criteria

Exclusion Criteria

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