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Trial record 66 of 588 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

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

Condition or disease Intervention/treatment Phase
Change of Transit or Circulation Obesity Dietary Supplement: soluble wheat bran fibre Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Prebiotic Fibre on Intestinal Health and Functioning
Study Start Date : July 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

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 Name: 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02491125     History of Changes
Other Study ID Numbers: NL52300.068.15
First Posted: July 7, 2015    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: October 2018