NCT06204978

Evaluation of Gastrointestinal Comfort Following Regular Consumption of Short-chain Fructo-oligosaccharides (10-20 g Per Day) by Children Aged 6-12 Years

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Tereos · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Gastrointestinal Tract

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	short-chain fructo-oligosaccharides (dose 1)	10 g / day at breakfast during 7 days (Day 8 - Day 14)
DIETARY_SUPPLEMENT	short-chain fructo-oligosaccharides (dose 2)	20 g / day at breakfast during 7 days (Day 8 - Day 14)
OTHER	Baseline	0 g / day of short-chain fructo-oligosaccharides during 7 days (Day 1 - Day 7)

Timeline

• Start date: 2022-11-30
• Primary completion: 2023-12-20
• Completion: 2023-12-20
• First posted: 2024-01-12
• Last updated: 2024-01-16

Locations

1 site across 1 country: France