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Completed

NCT Number: NCT05581615

Influence of Food Matrix on Prebiotic Efficacy in Inulin Type Fructans

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).

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Reading

Reading, RG6 6DZ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inulin

Other

Each intervention provided 10 g/d inulin split into two dosages of 5 g.

Primary outcomes

  1. Changes in level of Bifidobacterium spp.

    Time frame: 10 days

    Bifidobacterium spp. will be assessed by fluorescence in situ hybridisation - flow cytometry (FISH-FLOW) and 16S rRNA gene sequencing

Secondary outcomes

  1. Changes in level of total Bacteria

    Time frame: 10 days

    Total bacteria will be assessed by fluorescence in situ hybridisation - flow cytometry (FISH-FLOW)

  2. Changes in gut bacterial composition

    Time frame: 10 days

    Bacterial numbers will be assessed by fluorescence in situ hybridisation - flow cytometry (FISH-FLOW) and 16S rRNA gene sequencing

  3. Stool frequency

    Time frame: 10 days

    Numbers of stools will be recorded in daily diary

  4. Stool consistency

    Time frame: 10 days

    Stool consistency will be recorded in daily diary according to Bristol Stool Form Scale

  5. Bloating

    Time frame: 10 days

    Bloating will be recorded in daily diary according to a 4-point scale

  6. Abdominal pressure

    Time frame: 10 days

    Abdominal pressure will be recorded in daily diary according to a 4-point scale

  7. Abdominal pain

    Time frame: 10 days

    Abdominal pain will be recorded in daily diary according to a 4-point scale

  8. Flatulence

    Time frame: 10 days

    Flatulence will be recorded in daily diary according to a 4-point scale

  9. Changes in urinary metabolites

    Time frame: 10 days

    Urinary metabolites will be analysed by Nuclear magnetic resonance (NMR)

Sponsors and collaborators

Lead sponsor

Beneo-Institute

Industry

Collaborators

  • University of Reading

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 14, 2022
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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