Clinical trial NCT02491125: The Effect of Prebiotics on Gastrointestinal Functioning and Metabolism
Official title: Effect of Prebiotic Fibre on Intestinal Health and Functioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Change of Transit or Circulation
Obesity
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2015-07-07
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

Detailed description: 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.

Eligibility criteria: 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

  1. Straining in \>1/4 defecations;
  2. Lumpy or hard stools in \>1/4 defecations;
  3. Sensation of incomplete evacuation in \>1/4 defecations;
  4. Sensation of anorectal obstruction/blockade in \>1/4 defecations
  5. Manual maneuvers to facilitate \>1/4 defecations (e.g., digital evacuation, support of the pelvic floor); and/or
  6. \<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

Primary outcomes:
measure: Whole gut transit time [hours]
timeFrame: measured at baseline at week 1 and directly after the 12 week supplementation
Secondary outcomes:
measure: Gastric emptying [min]
timeFrame: measured at baseline at week 1 and directly after the 12 week supplementation
measure: Oro-cecal transit time [min]
timeFrame: measured at baseline at week 1 and directly after the 12 week supplementation
measure: Defecation frequency (bowel movement per day)
timeFrame: measured at baseline at week 1 and directly after the 12 week supplementation
measure: Energy expenditure
timeFrame: measured at baseline at week 1 and directly after the 12 week supplementation
measure: Substrate oxidation
timeFrame: measured at baseline at week 1 and directly after the 12 week supplementation
measure: Plasma inflammatory cytokines Interleukin-6,8 and 1 (pg/ml)
timeFrame: measured at baseline at week 1 and directly after the 12 week supplementation
measure: Adipose tissue gene expression
timeFrame: measured at baseline at week 1 and directly after the 12 week supplementation
measure: Gut permeability
timeFrame: measured at baseline at week 1 and directly after the 12 week supplementation
measure: Microbiota composition
timeFrame: measured at baseline at week 1 and directly after the 12 week supplementation
measure: Fecal Short chain fatty acid concentrations
timeFrame: measured at baseline at week 1 and directly after the 12 week supplementation
measure: Plasma short chain fatty acid concentrations
timeFrame: measured at baseline at week 1 and directly after the 12 week supplementation
Other outcomes:
Locations:
Study officials:
References:
citation: Muller M, Hermes GDA, Emanuel E C, Holst JJ, Zoetendal EG, Smidt H, Troost F, Schaap FG, Damink SO, Jocken JWE, Lenaerts K, Masclee AAM, Blaak EE. Effect of wheat bran derived prebiotic supplementation on gastrointestinal transit, gut microbiota, and metabolic health: a randomized controlled trial in healthy adults with a slow gut transit. Gut Microbes. 2020 Nov 9;12(1):1704141. doi: 10.1080/19490976.2019.1704141. Epub 2020 Jan 25.