NCT02378376

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
Last Updated

March 4, 2015

Status Verified

February 1, 2015

Enrollment Period

1.2 years

First QC Date

February 27, 2015

Last Update Submit

February 27, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Quantification of acetate, propionate and butyrate production in the colon after consumption of each wheat derived fiber fraction

    2 years

Study Arms (2)

Wheat derived fiber fraction 1

EXPERIMENTAL

Arabinoxylan oligosaccharides

Dietary Supplement: Arabinoxylan oligosaccharides

Wheat derived fiber fraction 2

EXPERIMENTAL

Dietary fiber enriched bran

Dietary Supplement: Dietary fiber enriched bran

Interventions

Arabinoxylan oligosaccharidesDIETARY_SUPPLEMENT
Wheat derived fiber fraction 1
Dietary fiber enriched branDIETARY_SUPPLEMENT
Wheat derived fiber fraction 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Kristin Verbeke

Study Record Dates

First Submitted

February 27, 2015

First Posted

March 4, 2015

Study Start

July 1, 2013

Primary Completion

September 1, 2014

Study Completion

February 1, 2015

Last Updated

March 4, 2015

Record last verified: 2015-02