Status:
COMPLETED
Long-term Effects of Arabinoxylans on Intestinal Barrier Function
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Obesity
Overweight
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The higher prevalence of overweight and obesity among the population contributes to increased incidences of chronic metabolic diseases. Obesity is considered a low-grade systemic inflammatory conditio...
Eligibility Criteria
Inclusion
- Overweight men/women (BMI 28-35 kg/m2)
- Besides overweight, healthy human beings
- Fasting glucose \<7.0 mmol/L
- Normal HbA1c (4.4 to 6.2%)
- Consistently stable body weight for at least 6 months (± 2 kg)
Exclusion
- Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L);
- Gastroenterological diseases or abdominal surgery;
- Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
- Abuse of products; alcohol (\>20 alcoholic consumptions per week) and drugs
- Smoking
- Plans to lose weight or following a hypocaloric diet;
- Use of any medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing;
- Regular use of laxation products;
- Use of antibiotics in the 90 days prior to the start of study.
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
- Known pregnancy, lactation (checked by a pregnancy test before start of study)
- Blood donation within 3 months before study period
- Prohibited use of pro-, pre- or synbiotics during study period and three months prior to start of study. A list with forbidden products will be provided (E4 PreProbiotics).
- Self-admitted HIV-positive state
- History of any side effects towards intake of pro- or prebiotic supplements of any kind
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01877044
Start Date
January 1 2013
End Date
January 1 2014
Last Update
July 8 2015
Active Locations (1)
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1
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229 HX