The Effect of Prebiotics on Gastrointestinal Functioning and Metabolism

Effect of Prebiotic Fibre on Intestinal Health and Functioning

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

Study Overview

• Status: Completed
• Conditions: Obesity; Change of Transit or Circulation
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: soluble wheat bran fibre

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 12 weeks placebo maltodextrin 15g/day ( 5 g in beverage, to be consumed three times a day)	Dietary supplement: Placebo; 12 weeks daily intake of 15g of maltodextrin; Other Names: Maltodextrin
Experimental: soluble wheat bran fibre; 12 weeks soluble wheat bran fibre 15g/day (5 g in beverage, to be consumed three times a day)	Dietary supplement: soluble wheat bran fibre; 12 weeks daily intake of 15g of soluble wheat bran fibre

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole gut transit time [hours]	Whole gut transit time as measured by radio-opaque marker method	measured at baseline at week 1 and directly after the 12 week supplementation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: March 23, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 7, 2015

Study Record Updates

• Last Update Posted (Actual): July 8, 2019
• Last Update Submitted That Met QC Criteria: July 4, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: NL52300.068.15