Influence of Food Matrix on Prebiotic Efficacy in Inulin Type Fructans

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Inulin

• Registration Number: NCT05581615
• Lead Sponsor: Beneo-Institute

Brief Summary

The aim of the study is to investigate whether the food matrix has an influence on the prebiotic efficacy (bifidobacteria growth) of chicory-derived Orafti® inulin in healthy adult volunteers. The main question it aims to answer is:

Does the food matrix influence the prebiotic effect of chicory-derived inulin in terms of stimulation of bifidobacteria in the gut microbiota Participants will receive one of three food items containing inulin or pure inulin dissolved in water daily for 10 days. The food items or pure inulin powder will deliver 10 g/d inulin split into two dosages of 5 g/d. They will provide stool samples before and at the end of the intake period. They will record any gastrointestinal sensations and bowel habits in a diary. Urinary samples will be collected at baseline and end of intervention for analysis of metabolites with Nuclear Magnetic resonance (NMR).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-20
• Primary Completion: 2021-05-22
• Study Completion: 2021-10-06
• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-12
• Study First Posted: 2022-10-14
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Volunteer is healthy at the time of pre-examination
• Volunteer is aged ≥ 18 to ≤ 65 years at the time of pre-examination
• Volunteer's BMI is ≥ 18,5 and ≤ 29,9
• Volunteer follows an average Western European diet
• Volunteer has a stool frequency of at least 3 bowel movements per week
• Volunteer is able and willing to comply with the study instructions
• Volunteer is suitable for participation in the study according to the investigator/study personnel
• Written informed consent is given by volunteer

Exclusion Criteria

• No command of any local language
• Gastrointestinal disorders including irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) or other conditions that might affect the gut environment
• Food allergies or intolerances
• Vegetarians, vegans and/or extreme diets including high protein/fibre, ketogenic, intermittent fasting and/or carnivore
• Using drugs (e.g. antibiotics, aspirin, proton pump inhibitors) influencing gastrointestinal function (8 weeks before intervention)
• Use of laxatives and labelled pre- and probiotics in the previous 4 weeks before the beginning of intervention
• Clinically significant diabetes
• Volunteers currently involved or will be involved in another clinical or food study
• History of drug (pharmaceutical or recreational) or alcohol abuse.
• Has received bowel preparation for investigative procedures in the 4 weeks prior to the study
• Has undergone surgical resection of any part of the bowel.
• If participants are pregnant or are lactating

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pure inulin	Inulin	2 x 5 g/d inulin
Shortbread containing inulin	Inulin	2 x per day shortbread containing 5 g inulin per serving
Milk chocolate containing inulin	Inulin	2 x per day milk chocolate containing 5 g inulin per serving
Rice drink containing inulin	Inulin	2 x per day rice drink containing 5 g inulin per serving

Primary Outcome Measures

Name	Time	Method
Changes in level of Bifidobacterium spp.	10 days	Bifidobacterium spp. will be assessed by fluorescence in situ hybridisation - flow cytometry (FISH-FLOW) and 16S rRNA gene sequencing

Secondary Outcome Measures

Name	Time	Method
Abdominal pressure	10 days	Abdominal pressure will be recorded in daily diary according to a 4-point scale
Changes in level of total Bacteria	10 days	Total bacteria will be assessed by fluorescence in situ hybridisation - flow cytometry (FISH-FLOW)
Stool frequency	10 days	Numbers of stools will be recorded in daily diary
Bloating	10 days	Bloating will be recorded in daily diary according to a 4-point scale
Abdominal pain	10 days	Abdominal pain will be recorded in daily diary according to a 4-point scale
Flatulence	10 days	Flatulence will be recorded in daily diary according to a 4-point scale
Changes in gut bacterial composition	10 days	Bacterial numbers will be assessed by fluorescence in situ hybridisation - flow cytometry (FISH-FLOW) and 16S rRNA gene sequencing
Changes in urinary metabolites	10 days	Urinary metabolites will be analysed by Nuclear magnetic resonance (NMR)
Stool consistency	10 days	Stool consistency will be recorded in daily diary according to Bristol Stool Form Scale

Trial Locations

Locations (1)

University of Reading; 🇬🇧 Reading, United Kingdom