In Vivo Quantification of Short Chain Fatty Acids Production in the Human Colon

NCT ID: NCT02378376

Last Updated: 2015-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

During this project the amount of SCFA produced in the colon after consumption of 2 different 13C-labelled wheat fiber fractions will be quantified.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Wheat derived fiber fraction 1

Arabinoxylan oligosaccharides

Group Type EXPERIMENTAL

Arabinoxylan oligosaccharides

Intervention Type DIETARY_SUPPLEMENT

Wheat derived fiber fraction 2

Dietary fiber enriched bran

Group Type EXPERIMENTAL

Dietary fiber enriched bran

Intervention Type DIETARY_SUPPLEMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Arabinoxylan oligosaccharides

Intervention Type DIETARY_SUPPLEMENT

Dietary fiber enriched bran

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Regular diet with 3 meals a day (minimal 5 times a week)
* BMI between 18.5 and 27 kg/m2

Exclusion Criteria

* Calorie restricted diet or other special diet during the study or during the last month prior to the study
* Antibiotics in the month prior to the study
* Former surgeries on the gastrointestinal tract, with the exception of an appendectomy
* use of the following types of medications with effects on the gastrointestinal tract during the last 2 weeks prior to the study (spasmolytica, anti-diarrhea, anti-constipation, probiotics)
* Chronic disease of the gastrointestinal tract such as Crohn's disease, ulcerative colitis, irritable bowel syndrome, chronic constipation, chronic frequent diarrhea, clinically relevant lactose intolerance
* Pregnancy, pregnancy desire or breastfeeding
* Diabetes (type 1 and 2)
* Blood donation in the past 3 months prior to the study
* Abnormal hemoglobin (Hb) levels in blood, men must have a Hb level between 14.0 and 18.0 g / dL and women between 12.0 and 16.0 g / dL
* Participation in studies in the past year in which radiation was used.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

KU Leuven

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kristin Verbeke

Professor Kristin Verbeke

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

s55383

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fiber Fermentation Study
NCT04570137 COMPLETED NA