CEN Experimental
Dijon, Burgundy, 21000, France
NCT Number: NCT06204978
The current intake of dietary fiber by children in France and Europe is below established nutritional recommendations. Therefore, promoting fiber consumption from childhood as part of a diversified diet is crucial. For over 20 years, the food industry has been using scFOS (short-chain fructo-oligosaccharides), a fiber produced from sugar beet, as an additional source of dietary fiber. This solution can help increase daily fiber intake, meet nutritional recommendations, and provide positive health effects. Although scFOS are commonly used, there has not yet been a prospective study specifically on children aged 6 to 12 to assess gastrointestinal comfort following their regular consumption at dietary doses of 10-20 g per day.
The European Food Safety Authority (EFSA) recommends that all manufacturers document the safety of food ingredients (EFSA, 2021). This is based on Directive 2002/46/EC, which states that substances added to foods, including those intended for specific groups, must be safe and bioavailable. The study aims to assess gastrointestinal comfort and scFOS tolerance in children aged 6 to 12 and is fully compliant with Directive 2002/46/EC and EFSA recommendations.
Looking for future studies?
Notify Me6 year–12 year
All sexes
Interventional
Not applicable
Dijon, Burgundy, 21000, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
10 g / day at breakfast during 7 days (Day 8 - Day 14)
20 g / day at breakfast during 7 days (Day 8 - Day 14)
0 g / day of short-chain fructo-oligosaccharides during 7 days (Day 1 - Day 7)
Time frame: Day 1, Day 2, Day 3,…Day 14
Daily gastrointestinal global and invidual symptom scores evaluated on 4-point Likert scales (1:none, 2:mild, 3:moderate, 4:severe) for the following symptoms: bloating, gurgling, flatulence, nausea, vomiting, abdominal pain, heartburn, acid reflux).
Time frame: Day 1, Day 2, Day 3, …Day 14
Number of stools per day
Time frame: Day 1, Day 2, Day 3, …Day 14
Daily score (Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 indicating softy stools, and 6 and 7 indicate diarrhoea)
Time frame: Day 1, Day 2, Day 3, …Day 14
Number and description of adverse event each day
Time frame: Day 1, Day 2, Day 3, …Day 14
Daily score (10-point numerical scale;from 1: "felt not at all well, in bad shape" to 10: "felt very well, in great shape");
Time frame: Day 14
Number of unused bags of product
Tereos
Industry
Acronym: FOSTI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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