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Gastrointestinal Tolerance of Erythritol-containing Beverages in Young Children

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ClinicalTrials.gov Identifier: NCT02016703
Recruitment Status : Completed
First Posted : December 20, 2013
Last Update Posted : July 19, 2017
Sponsor:
Collaborator:
Biofortis Mérieux NutriSciences
Information provided by (Responsible Party):
Cargill

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Tolerance Other: Erythritol drink Other: Placebo drink Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Gastrointestinal Tolerance of Erythritol-containing Beverages in Young Children
Study Start Date : March 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2010

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



Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Stool frequency [ Time Frame: 48 hours ]
  2. Stool consistency [ Time Frame: 48 hours ]
    Stools were assigned a consistency score using the Bristol Stool Scale

  3. 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.

  4. 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.



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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02016703


Locations
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France
Clinical Investigation Centre Louis Pradel Hospital
Bron, France, 69677
Biofortis Merieux NutriSciences
Nantes, France, 44800
Clinical Investigation Centre Robert Debré Hospital
Paris, France, 75935
Sponsors and Collaborators
Cargill
Biofortis Mérieux NutriSciences
Investigators
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Principal Investigator: Evelyne Jacqz-Aigrain, PhD Clinical Investigation Centre Robert Debré Hospital, Paris, France
Publications:
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Responsible Party: Cargill
ClinicalTrials.gov Identifier: NCT02016703    
Other Study ID Numbers: CER-TDEOH05
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: December 2013
Keywords provided by Cargill:
erythritol
polyol
laxation
gastrointestinal
tolerance
soft drinks
child
diarrhoea
Additional relevant MeSH terms:
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Erythritol
Vasodilator Agents