- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02378376
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
Status
Completed
Conditions
Intervention / Treatment
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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