Gastrointestinal Tolerance of Erythritol-containing Beverages in Young Children
NCT ID: NCT02016703
Last Updated: 2017-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
185 participants
INTERVENTIONAL
2006-03-31
2010-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Lactose, Sucrose & Corn Syrup Tolerance
NCT01789307
Effect of Formula on Infant Behavior
NCT02746016
Growth and Tolerance of Infants Fed Milk-Based Infant Formula
NCT03967132
Formula Tolerance of Term Infants
NCT04915937
Gastrointestinal Tolerance of Infant Formula
NCT02322138
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The children were divided into 4 dose groups. In each group of children, only one dose level was tested such that each child was exposed to only a single dose level versus placebo. The erythritol dose started at 5 grams and was increased by 10 g between each group of children only if the preceding dose level was found to have no significant GI tolerance effects. The effects on faecal parameters and gastrointestinal complaints were recorded in order to determine the threshold dose. After finding a significant difference in tolerance between erythritol and placebo in the 25 g dose cohort, a protocol amendment was approved allowing the investigators to study a dose of 20 g.
Test materials were prepared by Cargill, Vilvoorde, Belgium and supplied in bottles containing 250 mL of a noncarbonated fruit-flavoured (two flavours: strawberry and orange) clear drink sweetened with erythritol at four different dose levels: 5, 15, 20 and 25 g (equivalent to 2, 6, 8 and 10% w/v erythritol, respectively). Placebo was supplied in an identical manner but prepared with common nutritive carbohydrates (saccharose and maltodextrin) and providing an equivalent sweetness to that of the corresponding erythritol beverages (i.e.: 1.4, 4.2, 5.6 and 7% w/v).
In total 185 healthy young children aged 4-6 years were recruited at three clinical investigation centres after informed consent of both parents; 184 completed the study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
5 g group
5g erythritol dissolved in 250 ml (2% w/v) consumed within 15 min between meals (tested vs. 250 ml isosweet saccharose placebo under same conditions)
Erythritol drink
Placebo drink
15 g group
15g erythritol dissolved in 250 ml (6% w/v) consumed within 15 min between meals (tested vs. 250 ml isosweet saccharose placebo under same conditions)
Erythritol drink
Placebo drink
25 g group
25g erythritol dissolved in 250 ml (10% w/v) consumed within 15 min between meals (tested vs. 250 ml isosweet saccharose placebo under same conditions)
Erythritol drink
Placebo drink
20 g group
20g erythritol dissolved in 250 ml (8% w/v) consumed within 15 min between meals (tested vs. 250 ml isosweet saccharose placebo under same conditions)
Erythritol drink
Placebo drink
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Erythritol drink
Placebo drink
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age 4 to 6 years at Study D1 (day of consumption of the first beverage)
* Body Mass Index ³ 13 kg/m²
* Accustomed to having breakfast
* Having a regular defecation frequency inferior or equal to two per day
* Able to drink 250 mL within 15 minutes
* Toilet-trained / able to use a potty (both at day and night)
* Informed consent of both person entitled to parental rights
* Person entitled to parental rights affiliated to the French social security
Exclusion Criteria
* Participation in any non-invasive clinical trial up to 30 days before D1 of this study, including blood sampling and/ or, intravenous, inhalatory administration of substances
* Having a history of medical or surgical events that may significantly affect the study outcome, such as gastric and digestive diseases
* Any current metabolic or endocrine disease, including diabetes mellitus
* Use of medication, including antibiotics, laxatives and steroids
* Regular gastrointestinal complaints, such as stomach upsets, diarrhoea, constipation, flatulence, abdominal colic
4 Years
6 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biofortis Mérieux NutriSciences
OTHER
Cargill
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Evelyne Jacqz-Aigrain, PhD
Role: PRINCIPAL_INVESTIGATOR
Clinical Investigation Centre Robert Debré Hospital, Paris, France
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinical Investigation Centre Louis Pradel Hospital
Bron, , France
Biofortis Merieux NutriSciences
Nantes, , France
Clinical Investigation Centre Robert Debré Hospital
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bornet FR, Blayo A, Dauchy F, Slama G. Plasma and urine kinetics of erythritol after oral ingestion by healthy humans. Regul Toxicol Pharmacol. 1996 Oct;24(2 Pt 2):S280-5. doi: 10.1006/rtph.1996.0109.
Arrigoni E, Brouns F, Amado R. Human gut microbiota does not ferment erythritol. Br J Nutr. 2005 Nov;94(5):643-6. doi: 10.1079/bjn20051546.
Bornet FR, Blayo A, Dauchy F, Slama G. Gastrointestinal response and plasma and urine determinations in human subjects given erythritol. Regul Toxicol Pharmacol. 1996 Oct;24(2 Pt 2):S296-302. doi: 10.1006/rtph.1996.0111.
Tetzloff W, Dauchy F, Medimagh S, Carr D, Bar A. Tolerance to subchronic, high-dose ingestion of erythritol in human volunteers. Regul Toxicol Pharmacol. 1996 Oct;24(2 Pt 2):S286-95. doi: 10.1006/rtph.1996.0110.
Munro IC, Berndt WO, Borzelleca JF, Flamm G, Lynch BS, Kennepohl E, Bar EA, Modderman J. Erythritol: an interpretive summary of biochemical, metabolic, toxicological and clinical data. Food Chem Toxicol. 1998 Dec;36(12):1139-74. doi: 10.1016/s0278-6915(98)00091-x.
Storey D, Lee A, Bornet F, Brouns F. Gastrointestinal tolerance of erythritol and xylitol ingested in a liquid. Eur J Clin Nutr. 2007 Mar;61(3):349-54. doi: 10.1038/sj.ejcn.1602532. Epub 2006 Sep 20.
Lifshitz F, Ament ME, Kleinman RE, Klish W, Lebenthal E, Perman J, Udall JN Jr. Role of juice carbohydrate malabsorption in chronic nonspecific diarrhea in children. J Pediatr. 1992 May;120(5):825-9. doi: 10.1016/s0022-3476(05)80260-4. No abstract available.
Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. doi: 10.3109/00365529709011203.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CER-TDEOH05
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.