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

NCT ID: NCT06204978

Last Updated: 2024-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-30
• Study Completion Date: 2023-12-20

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

scFOS Dose 1

scFOS 10g

Group Type: OTHER

short-chain fructo-oligosaccharides (dose 1)

Intervention Type: DIETARY_SUPPLEMENT

10 g / day at breakfast during 7 days (Day 8 - Day 14)

Baseline

Intervention Type: OTHER

0 g / day of short-chain fructo-oligosaccharides during 7 days (Day 1 - Day 7)

scFOS Dose 2

scFOS 20g

Group Type: OTHER

short-chain fructo-oligosaccharides (dose 2)

Intervention Type: DIETARY_SUPPLEMENT

20 g / day at breakfast during 7 days (Day 8 - Day 14)

Baseline

Intervention Type: OTHER

0 g / day of short-chain fructo-oligosaccharides during 7 days (Day 1 - Day 7)

Interventions

short-chain fructo-oligosaccharides (dose 1)

10 g / day at breakfast during 7 days (Day 8 - Day 14)

Intervention Type: DIETARY_SUPPLEMENT

short-chain fructo-oligosaccharides (dose 2)

20 g / day at breakfast during 7 days (Day 8 - Day 14)

Intervention Type: DIETARY_SUPPLEMENT

Baseline

0 g / day of short-chain fructo-oligosaccharides during 7 days (Day 1 - Day 7)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy children who were willing to participate in the study during school period;
• Have regular stool frequency: less than or equal to 3 stools per day and greater than or equal to 3 stools per week during the week prior to enrollment;
• Wanting to maintain their dietary and physical activity habits during the study;
• Agree to participate and have written informed consent from their parents or legal representatives ;
• A parent or legal representative must have a smartphone compatible with the e-PRO data collection application.

Exclusion Criteria

• Children who had a high fiber intake, as determined by the PNNS-GS2 score during the 7 days prior to inclusion;
• Children who regularly experience gastrointestinal symptoms or have a known ongoing or chronic gastrointestinal condition;
• Children who have any known pathologies, allergies, or food intolerances;
• Children who have received antibiotic treatment in the 2 months prior to inclusion;
• Consumption of any dietary supplement or medication that affects intestinal transit or the gastrointestinal sphere (such as fiber-based supplements, prebiotics, probiotics, symbiotics, osmotic laxatives, or intestinal dressings) within the two weeks prior to inclusion;
• History of gastrointestinal tract surgery (excluding appendectomy);
• Any medical or surgical history or treatment that could potentially influence the study criteria according to the investigator;
• Children been involved in another study within the last 2 months;
• Girl who have reached menarche and experience dysmenorrhea (abdominal pain and/or changes in bowel movements);
• Parents or legal guardians who are unable to understand, speak, and read French fluently, as well as those who are likely to disregard the protocol and questionnaire completion;
• Legal representative who are unable to provide informed consent due to a court decision or any other condition that may affect their judgment;
• Not affiliated to a health insurance fund through their parents or legal representative.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CEN Biotech

INDUSTRY

Sponsor Role: collaborator

Tereos

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CEN Experimental

Dijon, Burgundy, France

Countries

France

Other Identifiers

C1712

Identifier Type: -

Identifier Source: org_study_id