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Completed

NCT Number: NCT02796989

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

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.

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Key information

Conditions

Healthy Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obese Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wheat Bran

Dietary Supplement

20 g each day

Placebo

Dietary Supplement

20 g each day

Primary outcomes

  1. The incremental plasma short-chain fatty acid concentrations will be measured using GC-FID after an intervention with wheat bran/placebo

    Time frame: 1 month

Secondary outcomes

  1. Changes in glucose levels (mg/dL)

    Time frame: 1 month

  2. Changes in insulin levels (pmol/L)

    Time frame: 1 month

  3. Changes in cholesterol levels (mg/dL)

    Time frame: 1 month

  4. Changes in free fatty acids levels (mmol/L)

    Time frame: 1 month

  5. Changes in triglyceride levels (mg/dL)

    Time frame: 1 month

  6. Gut permeability using 51-Cr-EDTA

    Time frame: 1 month

  7. Total gastrointestinal transit time

    Time frame: 1 month

  8. Changes in gut microbiota before and after the intervention using 16S rRNA sequencing

    Time frame: 1 month

  9. Changes in metabolite patterns in the feces before and after the intervention using gas chromatography coupled to mass spectrometry

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 13, 2016
Registry last updated
Feb 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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