Long-term Effects of Arabinoxylans on Intestinal Barrier Function
Raktažodžiai
Santrauka
Datos
| Paskutinį kartą patikrinta: | 06/30/2015 |
| Pirmasis pateikimas: | 06/04/2013 |
| Numatytas registravimas pateiktas: | 06/11/2013 |
| Pirmas paskelbtas: | 06/12/2013 |
| Paskutinis atnaujinimas pateiktas: | 07/05/2015 |
| Paskutinis atnaujinimas paskelbtas: | 07/07/2015 |
| Faktinė studijų pradžios data: | 12/31/2012 |
| Numatoma pirminio užbaigimo data: | 12/31/2013 |
| Numatoma studijų užbaigimo data: | 12/31/2013 |
Būklė ar liga
Intervencija / gydymas
Dietary Supplement: NAXUS
Dietary Supplement: Placebo
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Placebo Comparator: Placebo Maltodextrin | Dietary Supplement: Placebo |
| Experimental: NAXUS 7.5 grams Arabinoxylan | |
| Experimental: NAXUS 15.0 grams Arabinoxylan |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | Inclusion Criteria: - 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 Criteria: - 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 |
Rezultatas
Pirminės rezultatų priemonės
1. The primary objective of this study is to assess the change from baseline intestinal barrier function at 6 weeks, by performing a gut sugar permeability test. [Baseline and after 6 weeks of administration]
Antrinės rezultatų priemonės
1. To assess the change from baseline intestinal barrier function at 6 weeks, by assessing the tight junction structure and proteins in colonic biopsies. [Baseline and after 6 weeks of administration]
2. To assess the change from baseline local and systemic immune system performance at 6 weeks. [Baseline and after 6 weeks administration]
3. To assess the change from baseline prebiotic properties at 3 and 6 weeks, by collecting faecal samples, intestinal contents and mucosal contents. [Baseline, after 3 and after 6 weeks of administration]
4. To assess the change from baseline glucose and lipid metabolism at 3 and 6 weeks [Baseline, after 3 and after 6 weeks of adminstration]
5. To assess the effect of different doses of NAXUS administration on tolerance and digestive (dys)comfort. [At baseline, after 1 wk of administration, after 2 wks of administration, after 3 wks of administration, after 4 wks of administration, after 5 wks of administration, after 6 wks of administration (in total 7 times)]
