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

February 27, 2015 updated by: Kristin Verbeke, KU Leuven

In Vivo Quantification of Short Chain Fatty Acids Production in the Human Colon After Consumption of Different Cereal Fractions.

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

Study Overview

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wheat derived fiber fraction 1
Arabinoxylan oligosaccharides
Experimental: Wheat derived fiber fraction 2
Dietary fiber enriched bran

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantification of acetate, propionate and butyrate production in the colon after consumption of each wheat derived fiber fraction
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

February 27, 2015

First Submitted That Met QC Criteria

February 27, 2015

First Posted (Estimate)

March 4, 2015

Study Record Updates

Last Update Posted (Estimate)

March 4, 2015

Last Update Submitted That Met QC Criteria

February 27, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • s55383

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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