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Clinical Trials/NL-OMON42114
NL-OMON42114
Completed
Not Applicable

Effect of prebiotic fibres on Intestinal Health and Functioning - Prebiotics and metabolism

Medisch Universitair Ziekenhuis Maastricht0 sites48 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prevention of gastro-intestinal and chronic rmetabolic diseases
Sponsor
Medisch Universitair Ziekenhuis Maastricht
Enrollment
48
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
December 16, 2016
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Medisch Universitair Ziekenhuis Maastricht

Eligibility Criteria

Inclusion Criteria

  • \- Healthy, normal/overweight men and women (BMI \* 20 kg/m2 \<30kg/m2\)
  • \- Aged 20\-55 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
  • \- A slow gastro\-intestinal transit (\> 50th percentile based on Sadik et al. 2003, 2004\)

Exclusion Criteria

  • \- Woman lactating, pregnant 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, 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
  • \- Current use of medication interfering with study intervention or interfering with study endpoints/hypotheses
  • \- Not to be able to understand the study information

Outcomes

Primary Outcomes

Not specified

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