gastro-intestinal tolerance gut health
Conditions
Interventions
Intervention 1: 300 mg recombinant humaan lactoferrine with skimmed milkpowder
Intervention 2: 1000 mg recombinant humaan lactoferrine with skimmed milkpowder
Intervention 3: placebo = skimmed milkpow
Sponsors
Pharming Group
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy as assessed by the - TNO health and lifestyle questionnaire, (P8896 F02; in Dutch) - results of the pre-study safety laboratory tests 2. Volunteers aged > 25 and
Exclusion criteria
Exclusion criteria: 1. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study 2. Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances 3. Having a history of medical or surgical events that may significantly affect the study outcome 4. Frequent and/or intense sports practice (more than 10 hours/week) 5. Smoking 6. Alcohol consumption > 21 units/week for males and > 14 units/week for females. 7. Any history of any allergy, sensitivity or anaphylaxis, especially if related (but not limited) to food products (e.g. chocolate, wheat, dairy products, or milk-derived products, egg, nuts, etc.) and seasonal allergy (e.g. hay fever) 8. Current or intermittent gastro-intestinal complaints (stomach upsets, diarrhoea, constipation, flatulence, abdominal colic, etc.), or any known gastro-intestinal disorder (e.g. ulcerative colitis, Crohn*s disease) 9. Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening 10. Use of antibiotics or laxatives within 1 month before day 01 of the study 11. Reported slimming or medically prescribed diet 12. Reported vegan, vegetarian or macrobiotic 13. Pregnant or lactating female or wishing to become pregnant in the period of the study 14. Females not using acceptable contraception 15. Recent blood donation (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters are clinical laboratory and gastro-intestinal tolerance as measured by questionnaires. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters are human lactoferrin (hLF) in faeces and blood, and anti-hLF antibodies in blood | — |
Countries
Netherlands
Outcome results
None listed