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| Name | Class |
|---|---|
| CEN Biotech | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| scFOS Dose 1 | Other | scFOS 10g |
|
| scFOS Dose 2 | Other | scFOS 20g |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| short-chain fructo-oligosaccharides (dose 1) | Dietary Supplement | 10 g / day at breakfast during 7 days (Day 8 - Day 14) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal symptoms evolution | 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). | Day 1, Day 2, Day 3,…Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Stool frequency evolution | Number of stools per day | Day 1, Day 2, Day 3, …Day 14 |
| Bristol Stool scale evolution (Stool consistency) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CEN Experimental | Dijon | Burgundy | 21000 | France |
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| short-chain fructo-oligosaccharides (dose 2) | Dietary Supplement | 20 g / day at breakfast during 7 days (Day 8 - Day 14) |
|
| Baseline | Other | 0 g / day of short-chain fructo-oligosaccharides during 7 days (Day 1 - Day 7) |
|
| Day 1, Day 2, Day 3, …Day 14 |
| Adverse events (except gastro-intestinal symptoms) evolution | Number and description of adverse event each day | Day 1, Day 2, Day 3, …Day 14 |
| Well-being evolution | Daily score (10-point numerical scale;from 1: "felt not at all well, in bad shape" to 10: "felt very well, in great shape"); | Day 1, Day 2, Day 3, …Day 14 |
| Consumption compliance | Number of unused bags of product | Day 14 |
| ID | Term |
|---|---|
| C074807 | BaseLine dental cement |
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