The Effect of Prebiotics on Gastrointestinal Functioning and Metabolism

Not Applicable

Completed

• Conditions: Change of Transit or Circulation; Obesity
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: soluble wheat bran fibre

• Registration Number: NCT02491125
• Lead Sponsor: Maastricht University Medical Center

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.

Study Timeline

• Study First Submitted: 2015-03-23
• Study Start: 2015-07
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-07
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2018-10
• Last Update Submitted: 2019-07-04
• Last Update Posted: 2019-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	12 weeks placebo maltodextrin 15g/day ( 5 g in beverage, to be consumed three times a day)
soluble wheat bran fibre	soluble wheat bran fibre	12 weeks soluble wheat bran fibre 15g/day (5 g in beverage, to be consumed three times a day)

Primary Outcome Measures

Name	Time	Method
Whole gut transit time [hours]	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 Outcome Measures

Name	Time	Method
Gastric emptying [min]	measured at baseline at week 1 and directly after the 12 week supplementation	Gastric emptying measured by isotope breath test
Plasma inflammatory cytokines Interleukin-6,8 and 1 (pg/ml)	measured at baseline at week 1 and directly after the 12 week supplementation	IL-6, IL8,IL-1 measured by enzyme linked immunosorbent assay
Adipose tissue gene expression	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
Gut permeability	measured at baseline at week 1 and directly after the 12 week supplementation	Gut permeability as measured by multi sugar assay
Microbiota composition	measured at baseline at week 1 and directly after the 12 week supplementation	Microbiota composition as measured by illumina sequencing in feces
Oro-cecal transit time [min]	measured at baseline at week 1 and directly after the 12 week supplementation	Oro-cecal transit time measured by hydrogen breath test
Defecation frequency (bowel movement per day)	measured at baseline at week 1 and directly after the 12 week supplementation	Defecation frequency as measured via questionnaire
Energy expenditure	measured at baseline at week 1 and directly after the 12 week supplementation	Energy expenditure measured by indirect calorimetry
Substrate oxidation	measured at baseline at week 1 and directly after the 12 week supplementation	Fat and carbohydrate oxidation measured by indirect calorimetry
Fecal Short chain fatty acid concentrations	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
Plasma short chain fatty acid concentrations	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