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Trial record 66 of 593 for:    maltodextrin

The Effect of Prebiotics on Gastrointestinal Functioning and Metabolism

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

Tracking Information
First Submitted Date  ICMJE March 23, 2015
First Posted Date  ICMJE July 7, 2015
Last Update Posted Date July 8, 2019
Study Start Date  ICMJE July 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE
 (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  ICMJE
 (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  ICMJE The Effect of Prebiotics on Gastrointestinal Functioning and Metabolism
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Change of Transit or Circulation
  • Obesity
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 19, 2018)
48
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2015)
50
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02491125
Other Study ID Numbers  ICMJE NL52300.068.15
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maastricht University Medical Center
Study Sponsor  ICMJE Maastricht University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Maastricht University Medical Center
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP