Tolerance Clinical Trial
Official title:
Gastrointestinal Tolerance of Erythritol-containing Beverages in Young Children
Verified date | December 2013 |
Source | Cargill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Cargill | Biofortis Mérieux NutriSciences |
France,
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
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 |
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