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Completed

NCT Number: NCT02491125

The Effect of Prebiotics on Gastrointestinal Functioning and Metabolism

The study will investigate the effect of cereal based prebiotic fibres on intestinal health and functioning and host metabolism.

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Key information

About this study

A human dietary intervention study will be performed in overweight to obese subjects with a slow gastrointestinal transit time comparing the effects of a soluble prebiotic fibre vs. placebo on gut health, including gut microbiota composition, gastrointestinal transit time, metabolic health and quality of life.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Overweight to obese men and women (BMI ≥ 25 kg/m2 <35 kg/m2)
  • Aged 20-50 years
  • Caucasian
  • Normal fasting glucose (<6.1 mmol/L.)
  • Normal blood pressure (systolic blood pressure 100-140 mmHg, diastolic blood pressure 60-90 mmHg)
  • Weight stable in last 3 months (±2 kg)
  • A low defecation frequency, <4 times/week and no constipation or underlying pathology, as determined by gastro-intestinal questionnaires).
  • A slow whole gut transit (>35h)

Exclusion criteria

  • Woman lactating, pregnant (where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test) or (post)-menopausal
  • Regular smokers
  • People with intensive fitness training, eg. athletes (≥3 per week ≥ 1 hour training)
  • Diabetes Mellitus (defined as FPG ≥ 7.0 mmol/l and or 2h PG ≥ 11.1 mmol/l)
  • Gastro-intestinal diseases or abdominal surgery, cardiovascular diseases, cancer, liver or kidney malfunctioning (determined based on ALAT and creatinine levels, respectively) disease with a life expectation shorter than 5 years
  • Following a hypocaloric diet
  • Gluten intolerance
  • Regular use of laxation products, or use of antibiotics, probiotics or prebiotics 3 months prior to the start of the study
  • More than 2 symptoms occurring over a period of 12 weeks in the preceding 12 months such as
  • Straining in >1/4 defecations;
  • Lumpy or hard stools in >1/4 defecations;
  • Sensation of incomplete evacuation in >1/4 defecations;
  • Sensation of anorectal obstruction/blockade in >1/4 defecations
  • Manual maneuvers to facilitate >1/4 defecations (e.g., digital evacuation, support of the pelvic floor); and/or
  • <3 defecations/week
  • Current use of medication interfering with study intervention or interfering with study endpoints/hypotheses
  • Not to be able to understand the study information
  • Blood donation 2 months prior to the study and during the study
  • Participation in other studies

Treatment and study plan

soluble wheat bran fibre

Dietary Supplement

12 weeks daily intake of 15g of soluble wheat bran fibre

Placebo

Dietary Supplement

12 weeks daily intake of 15g of maltodextrin

Other names: Maltodextrin

Primary outcomes

  1. Whole gut transit time [hours]

    Time frame: measured at baseline at week 1 and directly after the 12 week supplementation

    Whole gut transit time as measured by radio-opaque marker method

Secondary outcomes

  1. Gastric emptying [min]

    Time frame: measured at baseline at week 1 and directly after the 12 week supplementation

    Gastric emptying measured by isotope breath test

  2. Oro-cecal transit time [min]

    Time frame: measured at baseline at week 1 and directly after the 12 week supplementation

    Oro-cecal transit time measured by hydrogen breath test

  3. Defecation frequency (bowel movement per day)

    Time frame: measured at baseline at week 1 and directly after the 12 week supplementation

    Defecation frequency as measured via questionnaire

  4. Energy expenditure

    Time frame: measured at baseline at week 1 and directly after the 12 week supplementation

    Energy expenditure measured by indirect calorimetry

  5. Substrate oxidation

    Time frame: measured at baseline at week 1 and directly after the 12 week supplementation

    Fat and carbohydrate oxidation measured by indirect calorimetry

  6. Plasma inflammatory cytokines Interleukin-6,8 and 1 (pg/ml)

    Time frame: measured at baseline at week 1 and directly after the 12 week supplementation

    IL-6, IL8,IL-1 measured by enzyme linked immunosorbent assay

  7. Adipose tissue gene expression

    Time frame: measured at baseline at week 1 and directly after the 12 week supplementation

    Adipose tissue gene expression measured by quantitative real time polymerase chain reaction

  8. Gut permeability

    Time frame: measured at baseline at week 1 and directly after the 12 week supplementation

    Gut permeability as measured by multi sugar assay

  9. Microbiota composition

    Time frame: measured at baseline at week 1 and directly after the 12 week supplementation

    Microbiota composition as measured by illumina sequencing in feces

  10. Fecal Short chain fatty acid concentrations

    Time frame: measured at baseline at week 1 and directly after the 12 week supplementation

    Fecal Short chain fatty acid concentrations measured by ion exchange chromatography with conductivity detection

  11. Plasma short chain fatty acid concentrations

    Time frame: measured at baseline at week 1 and directly after the 12 week supplementation

    Plasma short chain fatty acid concentrations measured by liquid chromatography-mass spectrometry

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Effect of Prebiotic Fibre on Intestinal Health and Functioning

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 7, 2015
Registry last updated
Jul 8, 2019

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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