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

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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

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.

Condition or disease Intervention/treatment Phase
Healthy Obese Dietary Supplement: Wheat bran Dietary Supplement: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Study Start Date : March 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Arm Intervention/treatment
Active Comparator: Healthy - Wheat Bran
Wheat bran 20 g each day
Dietary Supplement: Wheat bran
20 g each day

Placebo Comparator: Healthy - Placebo
Placebo 20 g each day
Dietary Supplement: Placebo
20 g each day

Active Comparator: Obese - Wheat bran
Wheat bran 20 g each day
Dietary Supplement: Wheat bran
20 g each day

Placebo Comparator: Obese - Placebo
Placebo 20 g each day
Dietary Supplement: Placebo
20 g each day




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Changes in glucose levels (mg/dL) [ Time Frame: 2 years ]
  2. Changes in insulin levels (pmol/L) [ Time Frame: 2 years ]
  3. Changes in cholesterol levels (mg/dL) [ Time Frame: 2 years ]
  4. Changes in free fatty acids levels (mmol/L) [ Time Frame: 2 years ]
  5. Changes in triglyceride levels (mg/dL) [ Time Frame: 2 years ]
  6. Gut permeability using 51-Cr-EDTA [ Time Frame: 2 years ]
  7. Total gastrointestinal transit time [ Time Frame: 2 years ]
  8. Changes in gut microbiota before and after the intervention using 16S rRNA sequencing [ Time Frame: 2 years ]
  9. Changes in metabolite patterns in the feces before and after the intervention using gas chromatography coupled to mass spectrometry [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796989


Locations
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Belgium
KU Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
KU Leuven

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Responsible Party: Kristin Verbeke, Professor Kristin Verbeke, KU Leuven
ClinicalTrials.gov Identifier: NCT02796989     History of Changes
Other Study ID Numbers: s58346
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018