Evaluating the Impact of Different Sugar Replacer Combinations on Gastrointestinal Tolerance

NCT05794100 | Completed

• 1 other identifier: KBE062 / BIO-2110
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sugar replacer; Gastrointestinal symptoms; GITQ; BHD-BSS; Acute; microbiota

Outcome Measures

Primary Outcomes (1)

• Difference in area under the curve (AUC) of the composite Gastrointestinal symptom score of each test product versus control

  AUC of the composite Gastrointestinal symptoms score based on GITQ (gastro-intestinal tolerance questionnaire)

  AUC between 0 to 48 hours after intake of products

Secondary Outcomes (13)

• Difference in the continuous AUC of the composite GI symptom score between doses within each formulation

  AUC between 0 to 48 hours after intake of products

• Difference in the continuous AUC of the composite GI symptom score between formulations within each dose

  AUC between 0 to 48 hours after intake of products

• Difference in the continuous AUC for each individual GI symptom score of test products as compared to control, dose within each formulation, and formulation within each dose

  AUC between 0 to 48 hours after intake of products

• Proportion of subjects who have a composite GI symptom score larger than 1 at each measured time point

  AUC between 0 to 48 hours after intake of products

• Proportion of subjects with diarrhea based on BHD-BSS (Bowel Habit Diary - Brictol Stool Scale)

  Evaluation over 24 hours following intake of products

Study Arms (10)

Test 1

ACTIVE COMPARATOR

No-sugar chewable candy containing Soluble Corn Fiber + Inulin + Allulose provided at a dose of 1 serving equivalent

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

Test 2

ACTIVE COMPARATOR

No-sugar chewable candy containing Soluble Corn Fiber + Inulin + Allulose provided at a dose of 1.75 serving equivalent

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

Test 3

ACTIVE COMPARATOR

No-sugar chewable candy containing Soluble Corn Fiber + Inulin + Allulose provided at a dose of 2.5 serving equivalent

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

Test 4

ACTIVE COMPARATOR

No-sugar chewable candy containing Soluble Corn Fiber + Inulin + FOS provided at a dose of 1 serving equivalent

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

Test 5

ACTIVE COMPARATOR

No-sugar chewable candy containing Soluble Corn Fiber + Inulin + FOS provided at a dose of 1.75 serving equivalent

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

Test 6

ACTIVE COMPARATOR

No-sugar chewable candy containing Soluble Corn Fiber + Inulin + FOS provided at a dose of 2.5 serving equivalent

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

Test 7

ACTIVE COMPARATOR

No-sugar chewable candy containing Maltitol + Polydextrose provided at a dose of 1 serving equivalent

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

Test 8

ACTIVE COMPARATOR

No-sugar chewable candy containing Maltitol + Polydextrose provided at a dose of 1.75 serving equivalent

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

Test 9

ACTIVE COMPARATOR

No-sugar chewable candy containing Maltitol + Polydextrose provided at a dose of 2.5 serving equivalent

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

Test 10

PLACEBO COMPARATOR

Control chewable candy made with sugar and provided at a dose of 1 serving equivalent

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

Interventions

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

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

Also known as: No sugar chewable candies

Test 1; Test 10; Test 2; Test 3; Test 4; Test 5; Test 6; Test 7; Test 8; Test 9

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, 18-55 years of age, inclusive at Visit 1 (Day -11).
• BMI of 18.5 to 32.0 kg/m2, inclusive, at Visit 1 (Day -11).
• 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).
• Consumes fiber at an amount no more than the average American diet \[based on consumption of high-fiber containing plant-based foods (e.g., fruits, vegetables, legumes, pulses, nuts, and products labeled as good or excellent sources of fiber)\].
• Smokes 10 cigarettes or less in a day and has no plan to change nicotine habits during the study period.
• 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.
• 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.
• Willing to limit alcohol consumption to ≤3 standard drinks/d and ≤7 standard drinks/week throughout the trial.
• 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.
• Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.

You may not qualify if:

• 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.
• 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.
• 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.
• 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.
• 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.
• 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).
• 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).
• Self-reported history (within 6 weeks of Visit 1; Day -11) of constipation or diarrhea at the discretion of the Clinical Investigator.
• 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.
• 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 \[defined as no change in medication regimen within the 3 mo prior to Visit 1 (Day -11)\].
• Any known food allergy as well as intolerance or sensitivity to study product ingredients (Appendix 13).
• Extreme dietary habits or physical activity patterns at the discretion of the Clinical Investigator.
• History or presence of cancer in the prior 2 y, except for non-melanoma skin cancer.
• Major trauma or any other surgical event within 3 mo of Visit 1 (Day -11).
• Signs or symptoms of an active infection of clinical relevance within 5 d of Visit 1 (Day -11). The visit may be rescheduled such that all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 d prior to Visit 1 (Day -11)\*

Sponsors & Collaborators

• Mondelēz International, Inc.: lead
• BioFortis: collaborator

Study Sites (1)

Biofortis Innovation Services

Addison, Illinois, 60101, United States

Location

Study Officials

• Kathleen M Kelley, MD

  BioFortis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Products have been produced with different shapes and with very close texture, colors and taste. They are packaged in individual portion bags labeled "Product 1" to "Product 10".
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each subject will be allocated to a sequence of consumption of the 10 different products

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: April 3, 2023
• Study Start: October 11, 2021
• Primary Completion: May 30, 2022
• Study Completion: July 30, 2022
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)