Gastrointestinal Tolerance of Erythritol-containing Beverages in Young Children

Tolerance Clinical Trial

Official title:

Gastrointestinal Tolerance of Erythritol-containing Beverages in Young Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02016703
• Other study ID #: CER-TDEOH05
• Status: Completed
• Phase: N/A
• First received: December 16, 2013
• Last updated: July 18, 2017
• Start date: March 2006
• Est. completion date: July 2010

Study information

• Verified date: December 2013
• Source: Cargill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Purpose of this study: assess the maximum tolerated bolus dose of erythritol, delivered in a clear beverage, compared with placebo (saccharose) in 4-6 year old children.

Description:

The study is a randomized placebo-controlled, double-blind cross-over trial designed to determine the gastrointestinal (GI) responses and maximum tolerated dose of erythritol in young children as a single oral dose in a beverage in-between meals.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: July 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

Inclusion Criteria:

• Healthy

• 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 clinical trial including blood sampling and/or administration of substances up to 90 days before D1 of the study

• 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

Related Conditions & MeSH terms

• Gastrointestinal
• Tolerance

Intervention

Other:
• Erythritol drink

• Placebo drink

Locations

Country	Name	City	State
France	Clinical Investigation Centre Louis Pradel Hospital	Bron
France	Biofortis Merieux NutriSciences	Nantes
France	Clinical Investigation Centre Robert Debré Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Cargill	Biofortis Mérieux NutriSciences

Country where clinical trial is conducted

France, 

References & Publications (8)

Arrigoni E, Brouns F, Amadò R. Human gut microbiota does not ferment erythritol. Br J Nutr. 2005 Nov;94(5):643-6. — View Citation

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. — View Citation

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. — View Citation

Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. — View Citation

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. Review. — View Citation

Munro IC, Berndt WO, Borzelleca JF, Flamm G, Lynch BS, Kennepohl E, Bär EA, Modderman J. Erythritol: an interpretive summary of biochemical, metabolic, toxicological and clinical data. Food Chem Toxicol. 1998 Dec;36(12):1139-74. Review. Erratum in: Food Chem Toxicol 1999 Jun;37(6):I-II. Bernt WO [corrected to Berndt WO]. — View Citation

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. Epub 2006 Sep 20. — View Citation

Tetzloff W, Dauchy F, Medimagh S, Carr D, Bär A. Tolerance to subchronic, high-dose ingestion of erythritol in human volunteers. Regul Toxicol Pharmacol. 1996 Oct;24(2 Pt 2):S286-95. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diarrhoea and/or significant gastrointestinal (GI) symptoms	Diarrhoea = a single watery stool (Bristol Stool Scale Score of 7) and/or >3 faeces (regardless of consistency) in a 24 h period.; Significant GI symptoms = any GI symptoms having a severity recorded as "severe intensity" in the symptom diary	48 hours
Secondary	Stool frequency		48 hours
Secondary	Stool consistency	Stools were assigned a consistency score using the Bristol Stool Scale	48 hours
Secondary	Gastrointestinal symptoms	Occurrence, intensity and frequency of borborygmi, excess flatus, abdominal pain, distended stomach (bloating) and nausea. For vomiting, information collected included occurrence and frequency. Symptom intensity was graded as 0 (none), 1 (mild), 2 (average) and 3 (severe) except for vomiting.	24 hours
Secondary	Urinary erythritol excretion	Urine was collected for 24 h after consumption of the test drink and analyzed by HPLC to estimate the proportion absorbed and excreted.	24 hours