Effect of prebiotic fibres on Intestinal Health and Functioning

Completed

Conditions: Prevention of gastro-intestinal and chronic rmetabolic diseases
10017943
10000546

Registration Number: NL-OMON42114

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 48

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
- Blood donation 2 months prior to the study and during the study
- Participation in other studies

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Whole gut transit measured by clinically validated method with radio-opaque<br /><br>marker. A capsule containing 10 radio-opaque markers is ingested for 6<br /><br>consecutive days to distribute the markers evenly throughout the body. On day<br /><br>seven, the radio-opaque markers are visible on fluoroscopy images and numbers<br /><br>of retained markers are counted. Whole gut transit is determined by dividing<br /><br>the number of retained markers by the daily dosage number. </p><br>

Secondary Outcome Measures