Biological Availability Clinical Trial
Official title:
Determination of Protein Digestibility of Whey and Zein in Ileostomates
Verified date | December 2019 |
Source | Wageningen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The evaluation of protein quality has top priority according to Food and Agricultural Organization of the United Nations. However, one aspect of protein quality, namely the digestibility of protein is largely unknown. A database on this matter is lacking as it is difficult to measure ileal digestibility in humans.
Status | Completed |
Enrollment | 10 |
Est. completion date | January 17, 2019 |
Est. primary completion date | January 17, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Male or female - Age between 18 and 60 - Willing to eat animal protein - Have a well-established and normally functioning terminal ileostomy, with stomal faeces of normal physiological consistency - Good general health, meaning subjects should be well-recovered from the ileostomy operation, their underlying disease should be cured or in remission and they should not have any other major health problems Exclusion Criteria: - Taken antibiotics or medication that majorly impair small intestinal digestion and absorption within eight weeks of participating in the study. - Have been pregnant or breastfeeding in the last 12 months, or plan to become pregnant during the study - Having renal impairment, coeliac disease or diabetes - Drug abuse - Alcohol consumption of >14 units per week. - Having an allergy or intolerance to dairy, corn products or fructose - Currently taking protein supplements and would not be willing to stop using these during the study - Being on a controlled diet or dietary weight loss regimen during the two weeks prior to the start of this study and/or during the study - Personnel of division of Human Nutrition, Wageningen University.. - Current participation in other research from the Division of Human Nutrition - Not having a general practitioner |
Country | Name | City | State |
---|---|---|---|
Netherlands | Division of Human Nutrition, Wageningen University | Wageningen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Wageningen University | Global Dairy Platform Incorporated, Massey University |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the ileal amino acid digestibility of Zein and Whey Protein Isolate | ileal digesta samples are collected in the nine hours after consumption of these proteins and after consumption of a protein-free diet. | 9 hours per day |
Status | Clinical Trial | Phase | |
---|---|---|---|
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