Gastrointestinal Tolerance of Erythritol-containing Beverages in Young Children

Cargill

Status: Completed

Conditions: Gastrointestinal; Tolerance

Treatments: Other: Placebo drink; Other: Erythritol drink

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02016703

CER-TDEOH05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 185 patients

Sex: All

Ages: 4 to 6 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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185 participants in 4 patient groups

5 g group

Experimental group

Description:

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)

Treatment:

Other: Erythritol drink

Other: Placebo drink

15 g group

Experimental group

Description:

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)

Treatment:

Other: Erythritol drink

Other: Placebo drink

25 g group

Experimental group

Description:

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)

Treatment:

Other: Erythritol drink

Other: Placebo drink

20 g group

Experimental group

Description:

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)

Treatment:

Other: Erythritol drink

Other: Placebo drink