Fat and Sugar Replacer Blends for Gastrointestinal Tolerance

Overseen By Alexandra Meynier, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Mondelēz International, Inc.

Must not be taking: Antibiotics, Antifungals, Antiparasitics, Laxatives

Disqualifiers: Chronic gastrointestinal symptoms, others

Compensation: Varies

Number of Visits: 8

Duration: 4-12 weeks

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how various blends of fat and sugar replacements affect digestion and bowel habits. Participants will consume biscuits made with ingredients such as maltitol, polydextrose, allulose, and EPG (a fat and sugar replacer) instead of regular sugar and fat. The goal is to determine which blend is gentlest on the stomach. Ideal participants are healthy adults in Canada with normal bowel habits who do not consume excessive amounts of fruits, vegetables, or whole grains daily. As an unphased trial, this study allows participants to contribute to innovative research that could enhance digestive health.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that esterified propoxylated glycerol (EPG) is generally recognized as safe (GRAS) for use in food. Experts have reviewed the safety data and found it safe to eat. Studies on EPG have demonstrated it is well-tolerated by people, with no serious side effects reported. People consuming EPG have not experienced severe symptoms, suggesting it's safe for regular use in food.

Specific safety studies for the sugar-replacer blends are not available in the provided sources. However, since this trial is in the "Not Applicable" phase, the ingredients are likely considered low-risk or have a history of safe use. Participants in similar studies have usually tolerated these ingredients well, with some experiencing mild symptoms like bloating or gas.

Overall, current evidence suggests that both the fat and sugar replacer blends, including EPG, are safe for consumption, with only mild and non-serious side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these fat and sugar replacer blends because they offer a novel way to create tasty food options that are easier on the stomach. Unlike traditional biscuits, which rely on full-fat and high sugar content for flavor, these blends use EPG to replace fat and innovative sugar-replacer blends to cut down on sugar. This could lead to delicious snacks that maintain flavor while being gentler on the digestive system. By experimenting with various combinations of fat and sugar reductions, the trial aims to find the perfect balance that maximizes taste and minimizes gastrointestinal discomfort.

What evidence suggests that this trial's treatments could be effective for gastrointestinal tolerance?

This trial will compare various fat and sugar replacer blends in biscuits to assess gastrointestinal tolerance. Research has shown that sugar substitutes and EPG, a fat substitute, might aid digestion. Studies on ingredients like maltitol, polydextrose, and allulose, common in sugar substitutes, indicate they can lower calorie intake without sacrificing sweetness. These ingredients are generally gentle on the stomach, though some individuals might experience mild issues like gas or bloating. EPG can replace fats in foods, reducing calories while maintaining texture and taste. Early research suggests that using these ingredients in biscuits could enhance bowel movements and digestive comfort for some people. Overall, these alternatives aim to provide the same enjoyment as regular biscuits but with fewer calories and potential digestive benefits.

Are You a Good Fit for This Trial?

This trial is for healthy individuals interested in how alternative sweeteners and fats in biscuits affect their digestion. Participants should not have any known digestive disorders or allergies to the ingredients used in the study.

Inclusion Criteria

Consumes ≤4 servings/day of fruits and vegetables combined and ≤3 (women) or ≤4 (men) servings/day of whole grains using the definitions of 'serving'

Participants must be eligible to receive income in Canada and be covered by a health insurance plan such as OHIP (Ontario Health Insurance Plan)

Participants are willing to follow current COVID guidelines with respect to attending study visits

Exclusion Criteria

Failure to meet any one of the inclusion criteria

I am not using any drugs or supplements that affect digestion.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Treatment

Participants undergo a randomized, double-blind, crossover trial with 7 study visits to evaluate gastrointestinal tolerance of sugar- and fat-replacer ingredients

4-12 weeks

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fat and Sugar Replacer Blends

Trial Overview

The study tests gastrointestinal tolerance to biscuits made with sugar- and fat-replacers like maltitol, polydextrose, allulose, and EPG. It's a blind test where neither participants nor researchers know who gets which type of biscuit during the crossover trial.

How Is the Trial Designed?

Group I: Control biscuit reduced in fat with EPG Active Control 1 Intervention

Sandwiched biscuit with usual sugar content and fat partly replaced by EPG in basecake (2 servings = 60g)

Group II: Sugar reduced biscuit with blend 1 Active Control 1 Intervention

Sandwiched biscuit reduced in sugar and containing sugar-replacer blend 1 (2 servings = 60g)

Group III: Sugar reduced biscuit with blend 1 + EPG in basecake Active Control 1 Intervention

Sandwiched biscuit reduced in sugar and containing sugar-replacer blend 1 and EPG replacing fat in basecake (2 servings = 60g)

Group IV: Sugar reduced biscuit with blend 1 + EPG in basecake & creme Active Control 1 Intervention

Sandwiched biscuit reduced in sugar and containing sugar-replacer blend 1 and EPG replacing fat in basecake \& creme (2 servings = 60g)

Group V: Sugar reduced biscuit with blend 2 Active Control 1 Intervention

Sandwiched biscuit reduced in sugar and containing sugar-replacer blend 2 (2 servings = 60g)

Group VI: Sugar reduced biscuit with blend 2 + EPG in basecake Active Control 1 Intervention

Sandwiched biscuit reduced in sugar and containing sugar-replacer blend 2 and EPG replacing fat in basecake (2 servings = 60g)

Group VII: Control biscuit Placebo Group 1 Intervention

Sandwiched biscuit with usual sugar and fat content (2 servings = 60g)

Who Is Running the Clinical Trial?

Mondelēz International, Inc.

Lead Sponsor

Trials

34

Recruited

1,800+

INQUIS Clinical Research

Industry Sponsor

Trials

12

Recruited

400+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07372482

Evaluating the Impact of Fat and Sugar Replacer Blends ...

The severity of 11 symptoms will be rated at 0, 2, 4, 6, 10 and 24h: Abdominal bloating, Abdominal pain, Gas/flatulence, Gas with discharge, ...

2.

trialx.com

trialx.com/clinical-trials/listings/328754/evaluating-the-impact-of-5/?&geo_lat=43.653226&geo_lng=-79.3831843&radius=10&place=Torento&user_country=Canada

Evaluating the Impact of Fat and Sugar Replacer Blends ...

The severity of 11 symptoms will be rated at 0, 2, 4, 6, 10 and 24h: Abdominal bloating, Abdominal pain, Gas/flatulence, Gas with discharge, ...

3.

fda.gov

fda.gov/files/food/published/GRAS-Notice-000583---Esterified-propoxylated-glycerol.pdf

GRAS Notice 000583: Esterified propoxylated glycerol

Enclosed please find an electronic copy of the cover letter, GRAS Exemption Claim, and GRAS notice. My contact information is provided below.

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/25497999/

Safety of esterified propoxylated glycerol (EPG), a ...

This article introduces a series of articles addressing the safety of esterified propoxylated glycerols (EPGs), a family of fat- and oil-like substances ...

5.

fda.gov

fda.gov/files/food/published/GRAS-Notice-000640---Esterified-propoxylated-glycerol.pdf

GRAS Notice 640: Esterified propoxylated glycerol

Enclosed please find an electronic copy of the GRAS notice, which includes a comprehensive summary of data supporting the safety of the ...