The Effect of Prebiotics on Gastrointestinal Functioning and Metabolism

• ClinicalTrials.gov Identifier: NCT02491125
• Recruitment Status: Completed
• First Posted: July 7, 2015
• Last Update Posted: July 8, 2019
• Sponsor: Maastricht University Medical Center
• Information provided by (Responsible Party): Maastricht University Medical Center

Tracking Information

• First Submitted Date: March 23, 2015
• First Posted Date: July 7, 2015
• Last Update Posted Date: July 8, 2019
• Study Start Date: July 2015
• Actual Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 4, 2019)

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

• Original Primary Outcome Measures (submitted: July 1, 2015): Whole gut transit time [hours] [ Time Frame: change from baseline at week 1 and at 12 week supplementation ]
• Change History: Complete list of historical versions of study NCT02491125 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: July 4, 2019)

• 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
• 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
• 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
• Energy expenditure [ Time Frame: measured at baseline at week 1 and directly after the 12 week supplementation ]
  Energy expenditure measured by indirect calorimetry
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Original Secondary Outcome Measures (submitted: July 1, 2015)

• Gastric emptying [min] [ Time Frame: change from baseline at week 1 and at 12 week supplementation ]
• Oro-cecal transit time [min] [ Time Frame: change from baseline at week 1 and at 12 week supplementation ]
• Defecation frequency [ Time Frame: change from baseline at week 1 and at 12 week supplementation ]
• Energy expenditure and substrate utilization [ Time Frame: change from baseline at week 1 and at 12 week supplementation ]
  Including systemic metabolic, inflammatory and immunological markers, energy and substrate utilization, adipose tissue gene and protein expression
• Systemic inflammatory cytokines [ Time Frame: change from baseline at week 1 and at 12 week supplementation ]
• Adipose tissue protein and gene expression [ Time Frame: change from baseline at week 1 and at 12 week supplementation ]
• Gut permeability [ Time Frame: change from baseline at week 1 and at 12 week supplementation ]
• Microbiota composition and activity [ Time Frame: change from baseline at week 1 and at 12 week supplementation ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Prebiotics on Gastrointestinal Functioning and Metabolism
• Official Title: Effect of Prebiotic Fibre on Intestinal Health and Functioning
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Basic Science

Condition

• Change of Transit or Circulation
• Obesity

Intervention

• Dietary Supplement: soluble wheat bran fibre
  12 weeks daily intake of 15g of soluble wheat bran fibre
• Dietary Supplement: Placebo
  12 weeks daily intake of 15g of maltodextrin
  Other Name: Maltodextrin

Study Arms

• Placebo Comparator: Placebo
  12 weeks placebo maltodextrin 15g/day ( 5 g in beverage, to be consumed three times a day)
  Intervention: Dietary Supplement: Placebo
• Experimental: soluble wheat bran fibre
  12 weeks soluble wheat bran fibre 15g/day (5 g in beverage, to be consumed three times a day)
  Intervention: Dietary Supplement: soluble wheat bran fibre

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 19, 2018): 48
• Original Estimated Enrollment (submitted: July 1, 2015): 50
• Actual Study Completion Date: December 2016
• Actual Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02491125
• Other Study ID Numbers: NL52300.068.15
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Maastricht University Medical Center
• Study Sponsor: Maastricht University Medical Center
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Maastricht University Medical Center
• Verification Date: October 2018