Influence of Food Matrix on Prebiotic Efficacy in Inulin Type Fructans

Healthy Clinical Trial

Official title:

Randomized Four-arm Trial Investigating the Effects of Different Food Matrices on the Prebiotic Efficacy of Inulin Type Fructans (ITF) From Chicory Root

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05581615
• Other study ID #: STUDY Number - 36/2020
• Status: Completed
• Phase: N/A
• Start date: November 20, 2020
• Est. completion date: October 6, 2021

Study information

• Verified date: December 2022
• Source: Beneo-Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: October 6, 2021
• Est. primary completion date: May 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Inulin
Each intervention provided 10 g/d inulin split into two dosages of 5 g.

Locations

Country	Name	City	State
United Kingdom	University of Reading	Reading

Sponsors (2)

Lead Sponsor	Collaborator
Beneo-Institute	University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

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