Gastrointestinal Tolerance of Erythritol-containing Beverages in Young Children

July 18, 2017 updated by: Cargill
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

185

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69677
        • Clinical Investigation Centre Louis Pradel Hospital
      • Nantes, France, 44800
        • Biofortis Mérieux NutriSciences
      • Paris, France, 75935
        • Clinical Investigation Centre Robert Debré Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Other: Erythritol drink
Other: Placebo drink
Experimental: 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)
Other: Erythritol drink
Other: Placebo drink
Experimental: 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)
Other: Erythritol drink
Other: Placebo drink
Experimental: 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)
Other: Erythritol drink
Other: Placebo drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diarrhoea and/or significant gastrointestinal (GI) symptoms
Time Frame: 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
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stool frequency
Time Frame: 48 hours
48 hours
Stool consistency
Time Frame: 48 hours
Stools were assigned a consistency score using the Bristol Stool Scale
48 hours
Gastrointestinal symptoms
Time Frame: 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.
24 hours
Urinary erythritol excretion
Time Frame: 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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cargill

Collaborators

Biofortis Mérieux NutriSciences

Investigators

  • Principal Investigator: Evelyne Jacqz-Aigrain, PhD, Clinical Investigation Centre Robert Debré Hospital, Paris, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

December 16, 2013

First Submitted That Met QC Criteria

December 16, 2013

First Posted (Estimate)

December 20, 2013

Study Record Updates

Last Update Posted (Actual)

July 19, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CER-TDEOH05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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