Gastrointestinal, Tolerance
Conditions
Keywords
erythritol, polyol, laxation, gastrointestinal, tolerance, soft drinks, child, diarrhoea
Brief 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.
Detailed 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.
Interventions
OTHERErythritol drink
OTHERPlacebo drink
Sponsors
Biofortis Mérieux NutriSciences
Cargill
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diarrhoea and/or significant gastrointestinal (GI) symptoms | 48 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool frequency | 48 hours | — |
| Stool consistency | 48 hours | Stools were assigned a consistency score using the Bristol Stool Scale |
| Gastrointestinal symptoms | 24 hours | 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. |
| Urinary erythritol excretion | 24 hours | Urine was collected for 24 h after consumption of the test drink and analyzed by HPLC to estimate the proportion absorbed and excreted. |
Countries
France
Outcome results
None listed