Effect of diet on microbiota composition in the small intestine bacterial gutflora microbiota composition
Conditions
Interventions
A high-protein/low-carbohydrate diet (26,7E% protein, 38.2E% carbohydrate), a
low-protein/high-carbohydrate diet (7E% protein, 59.6E% carbohydrate).
Sponsors
NIZO food research BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Healthy males • Age 18-30yrs • BMI between 20-30 kg/m2 • Regular bowel movement (defecation on average once a day) • Signed informed consent
Exclusion criteria
Exclusion criteria: • History or presence of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject*s ability to participate in the study (e.g. diabetes, cardiovascular disease, gastrointestinal disease, renal failure, cancer, infectious disease). • Presence of swallowing disorder • Use of any prescribed or non-prescribed medication (other than paracetamol) including antacids, analgesics, and herbal remedies during the three (3) weeks prior to study start. • Carrying a pacemaker or any other (implanted) medical electronic device • Scheduled for an MRI scan during the study period • Tobacco smoker • Unstable body weight (weight gain or loss >5kg in the past 3 months) • Use of antibiotics within 2 months of starting the study or planned during the study • Use of pro- or prebiotics • Constipation/infrequent bowel movement • Abuse of drugs/alcohol (alcohol: >4 consumptions/day or >20 consumptions/week) • Participation in another biomedical study • Having diarrhoea within 2 months prior to the study start • Vegetarianism/Veganism • Allergic for dairy products (milk allergy or lactose intolerance) • Known or suspected allergy to any product used in this study • Personnel of Wageningen University, Division of Human Nutrition. • Current participation in other research from the Division of Human Nutrition • Not willing to have an X-ray if the capsule is not recovered from the faeces
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of the IntelliCap® system when used as a gastrointestinal fluid sampling device, as assessed by reporting adverse events (AE) and serious adverse events (SAEs) that occur during the study along with their severity and potential relationship to the IntelliCap® system. Small intestinal microbiota composition after the 2 dietary intervention periods, analysed by 16S pyrosequencing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Small intestinal microbiota composition as compared to the faecal microbiota composition, analysed by 16S pyrosequencing. | — |
Countries
Netherlands
Outcome results
None listed