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The Impact of Modified Wheat Bran on Carbohydrate Fermentation in the Colon in Healthy and Obese Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02796989
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Kristin Verbeke, KU Leuven

Tracking Information
First Submitted Date  ICMJE May 27, 2016
First Posted Date  ICMJE June 13, 2016
Last Update Posted Date January 29, 2018
Study Start Date  ICMJE March 2016
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2016)
The incremental plasma short-chain fatty acid concentrations will be measured using GC-FID after an intervention with wheat bran/placebo [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02796989 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2016)
  • Changes in glucose levels (mg/dL) [ Time Frame: 2 years ]
  • Changes in insulin levels (pmol/L) [ Time Frame: 2 years ]
  • Changes in cholesterol levels (mg/dL) [ Time Frame: 2 years ]
  • Changes in free fatty acids levels (mmol/L) [ Time Frame: 2 years ]
  • Changes in triglyceride levels (mg/dL) [ Time Frame: 2 years ]
  • Gut permeability using 51-Cr-EDTA [ Time Frame: 2 years ]
  • Total gastrointestinal transit time [ Time Frame: 2 years ]
  • Changes in gut microbiota before and after the intervention using 16S rRNA sequencing [ Time Frame: 2 years ]
  • Changes in metabolite patterns in the feces before and after the intervention using gas chromatography coupled to mass spectrometry [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact of Modified Wheat Bran on Carbohydrate Fermentation in the Colon in Healthy and Obese Subjects
Official Title  ICMJE Not Provided
Brief Summary During this project the effect of modified wheat bran on colon health and systemic health will be evaluated in a long-term intervention study in healthy and obese subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE
  • Healthy
  • Obese
Intervention  ICMJE
  • Dietary Supplement: Wheat bran
    20 g each day
  • Dietary Supplement: Placebo
    20 g each day
Study Arms  ICMJE
  • Active Comparator: Healthy - Wheat Bran
    Wheat bran 20 g each day
    Intervention: Dietary Supplement: Wheat bran
  • Placebo Comparator: Healthy - Placebo
    Placebo 20 g each day
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: Obese - Wheat bran
    Wheat bran 20 g each day
    Intervention: Dietary Supplement: Wheat bran
  • Placebo Comparator: Obese - Placebo
    Placebo 20 g each day
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2018)
50
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2016)
100
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged between 18 and 65 years old
  • BMI between 18 and 25 kg/m² OR higher than 30 kg/m²
  • Regular diet
  • Not dieting

Exclusion Criteria:

  • Use of antibiotics in the month preceding the study
  • Diabetes Type 1 or 2
  • Abdominal surgery (except from appendectomy)
  • Use of medication that affects the gastrointestinal tract during the last 2 weeks prior to the study including spasmolytics, anti-diarrhoea medication, anti-constipation medication
  • Use of pre- or probiotic supplements in the month preceding the study
  • Chronic gastrointestinal diseases, such as inflammatory bowel disease (Crohn's disease, ulcerative colitis), irritable bowel disease…
  • Pregnancy or lactation
  • Blood donation in the last 3 months
  • Abnormal Hb-level (Standard range between 14 and 18 g/dL for men and between 12 and 16 g/dL for women)
  • Participation in clinical studies involving radiation exposure in the past year
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02796989
Other Study ID Numbers  ICMJE s58346
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kristin Verbeke, KU Leuven
Study Sponsor  ICMJE KU Leuven
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account KU Leuven
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP